A Study for Treatment of Pain in Patients With Diabetic N... | NCT00785577 | Trialant
NCT00785577
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
May 31, 2012Estimated
Enrollment
273Actual
Phase
Phase 2
Conditions
Diabetic Neuropathy, Painful
Interventions
Placebo
Pregabalin
LY545694 21 mg
LY545694 49 mg
LY545694 105 mg
Countries
United States
Mexico
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT00785577
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
11977
Secondary IDs
ID
Type
Description
Link
H8C-MC-LQBF
Other Identifier
Eli Lilly and Company
Brief Title
A Study for Treatment of Pain in Patients With Diabetic Neuropathy.
Official Title
A Phase 2 Study of the Effects of LY545694, an iGluR5 Antagonist, in the Treatment of Subjects With Painful Diabetic Neuropathy.
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Apr 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2008
Primary Completion Date
May 2010Actual
Completion Date
Jun 2010Actual
First Submitted Date
Nov 3, 2008
First Submission Date that Met QC Criteria
Nov 3, 2008
First Posted Date
Nov 5, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 25, 2011
Results First Submitted that Met QC Criteria
Apr 30, 2012
Results First Posted Date
May 31, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 25, 2011
Certification/Extension First Submitted that Passed QC Review
Feb 25, 2011
Certification/Extension First Posted Date
Mar 11, 2011Estimated
Last Update Submitted Date
Apr 30, 2012
Last Update Posted Date
May 31, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to test whether a new treatment will be safe and effective in treating pain. Patients with diabetic peripheral neuropathy will be included.
Detailed Description
Not provided
Conditions Module
Conditions
Diabetic Neuropathy, Painful
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
273Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules thrice daily (TID) po for 6 weeks
Drug: Placebo
Pregabalin
Active Comparator
Pregabalin thrice daily (TID) oral for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6
LY545694 placebo BID po for 5 weeks
Drug: Pregabalin
LY545694 21 mg
Experimental
LY545694 21 milligrams (mg) BID po for 1 week
Pregabalin placebo TID po for 6 weeks
Drug: LY545694 21 mg
LY545694 49 mg
Experimental
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
Pregabalin placebo TID po for 6 weeks
Drug: LY545694 49 mg
LY545694 105 mg
Experimental
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Pregabalin placebo TID po for 6 weeks
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
LY545694 placebo BID po for 5 weeks
Pregabalin placebo capsules TID po for 6 weeks
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks
This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Baseline, 5 weeks
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks
This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Baseline, 5 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have pain due to peripheral neuropathy based on disease diagnostic criteria: must have Type 1 or Type 2 diabetes mellitus, pain must being in the feet, with relatively symmetrical onset, daily pain must be present for at least 6 months, and diagnosis must be confirmed by a score of at least 3 on Part B of the Michigan Neuropathy Screening Instrument.
Have stable glycemic control, and glycated hemoglobin (HbA1c) less than or equal to 10%
Mean score of at least 4 on the 24-hour average page severity assessment from (from daily diary) Visits 2 to 3.
Fully completed daily diaries for at least 70% of the days between Visit 2 and 3.
Women must test negative for a serum pregnancy test at Visit 1, and must agree to use medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of study drug.
Are competent and able to freely give own informed consent.
Have an educational level and degree of understanding such that they can communicate intelligible with the investigator and study coordinator.
Have been judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol.
Exclusion Criteria:
Have historical exposure to drugs known to cause neuropathy, or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have been responsible for neuropathy.
Have pain that cannot be clearly differentiated from or conditions that interfere with the assessment of diabetic neuropathy pain.
Have had treatment with any centrally active neuroleptic drug within 30 days of visit 3.
Have had intolerance to pregabalin or have frequent and/or severe allergic reactions with multiple medications.
Have current or previous (within the past 1 year) Axis 1 diagnosis of major depressive disorder, mania, bipolar disorder, psychosis, dysthymia, generalized anxiety disorder, alcohol or eating disorders according to Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria, as determined by the investigator and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
Have a serious of unstable cardiovascular, hepatic, renal, respiratory, ophthalmologic, gastrointestinal, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition that in the opinion of the investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
Have alanine aminotransaminase > 2 times upper limit of normal at Visit 1, based on reference ranges of central lab.
Have prior renal transplant, current renal dialysis, or serum creatinine laboratory values > 1.5 times upper limit of normal, based on reference ranges of the central lab at Visit 1.
Have a diagnosis or history of glaucoma.
Are taking excluded medication that cannot be stopped and washed out prior to Visit 2.
Have history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Are judged clinically by the investigator to be at suicidal risk in the opinion of the investigator based upon clinical interview and the Columbia Suicide-Severity Rating Scale.
Have a positive urine drug screen for any substance of abuse or excluded medication.
Are unwilling or unable to comply with the use of a data collection device to directly record data from the subject (daily diary).
Are pregnant or breast-feeding.
Are investigator site personnel directly affiliated with this study and/or their immediate families.
Are Lilly employees.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Have a history of recurrent seizures other than febrile seizures.
Have a history of severe gastroparesis.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Greenbrae
California
94904
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Study Period 1 was an up to 5-week screening phase when participants stopped use of excluded medications (525 participants entered; 252 discontinued ). Study Period 2 was a 5-week, double-blind therapy period when randomization and dispensing of study drug occurred. Study Period 3 was a 1-week washout phase when all study medication was stopped.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
FG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
Pregabalin TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6
LY545694 placebo BID po for 5 weeks
Pregabalin
LY545694 21 mg
Drug
LY545694 21 mg BID po for 1 week
Pregabalin placebo TID po for 6 weeks
LY545694 21 mg
LY545694
LY545694 49 mg
Drug
LY545694 escalated to 49 mg BID po for 1 week during Week 2.
Pregabalin placebo TID po for 6 weeks.
LY545694 49 mg
LY545694
LY545694 105 mg
Drug
LY545694 105 mg BID po for 5 weeks
Pregabalin placebo TID po for 6 weeks
LY545694 105 mg
LY545694
Change From Baseline in Weekly Mean Worst Daily Pain Severity Score at 5 Weeks
This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Baseline, 5 weeks
Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score
This scale measured the number of participants with a 30% reduction in weekly mean 24-hour APS score from baseline to endpoint. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).
Baseline through 5 weeks
Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks
Average BPI-I measured self-reported degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Baseline, 5 weeks
Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks
BPI-S measured self-reported severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Baseline, 5 weeks
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks
CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Baseline, 5 weeks
Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks
PGI-I measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Week 5
Change From Baseline in Short-form McGill Pain Questionnaire (SF-MPQ) Sensory Subscale Score at 5 Weeks
SF-MPQ consisted of 11 sensory descriptors describing pain that were rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Baseline, 5 weeks
Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks
ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represent better sleep.
Baseline, 5 weeks
Change From Baseline in Neuropathy-Specific Quality of Life (NeuroQoL) Questionnaire Score at 5 Weeks
NeuroQoL had 29 items: 13 assessed specific somatic experiences (pain, lost/reduced feeling, and diffuse sensory-motor symptoms); 14 assessed specific functional, social, and emotional experiences (restrictions in daily living activities, disruptions in social relationships, and emotional distress); 2 items assessed QoL and overall satisfaction. Items reported on a 5-point scale (never/not at all to all of the time/very much). Higher mean scores=more severe symptoms/greater disruption in functioning. First 27 items also associate with 3-point bothersome/importance scale (1=none to 3=very).
Baseline, 5 weeks
Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks
The SF-36 Health Status Survey was a generic, health-related scale assessing participants' quality of life on 8 domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health) and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.
Baseline, 5 weeks
Change From Baseline of European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score
The EQ-5D was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant.
Baseline, 5 weeks
Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks
The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Baseline, 5 weeks
Number of Participants Who Discontinued Due to Adverse Events (AEs) During the Therapy (Double-blind) Phase and 1-Week Washout (Follow-up) Phase
Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.
Baseline through 6 weeks
Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values
The number of participants by treatment group who had abnormal high or low laboratory values was reported by the investigator and summarized as serious adverse events (SAEs) from the "Investigations" system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module.
Baseline through 5 weeks
Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks
Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Baseline, 5 weeks
Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks
Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Baseline, 5 weeks
Number of Participants With Electrocardiogram Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas
The number of participants having QTcF and QTcB change ≥ 30 msec was summarized.
Baseline through 5 weeks
Percentage of Participants With Reported Hypoglycemic Events
Percentage of participants who reported hypoglycemic (lower than normal level of blood glucose) episodes was summarized as other non-serious adverse events (AEs) from the "Investigations" system organ class (preferred term = hypoglycemia). A listing of AEs is located in the Reported Adverse Event module.
Baseline through 5 weeks
Change From Baseline in Overall Total Quick Inventory of Depressive Symptomatology (QIDS) Score
The QIDS was a 16-item patient-rated measure of depressive symptomatology. Each item had a 0 to 3 point scale. The total score ranged from 0 to 27 with higher scores indicative of greater severity. QIDS was calculated by summing the scores from the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) major depressive disorder criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes.
Baseline, 5 weeks
Number of Participants With Suicidal Behaviors and Ideations
The Columbia Suicide Severity Rating Scale (C-SSRS) captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations were provided. Suicidal behavior = a "yes" answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation = a "yes" answer to any 1 of 5 suicidal ideation questions, which included the wish to be dead and 4 different categories of active suicidal ideation.
Baseline through week 5
Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks
This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, follow-up questions rated the degree to which the issue impaired his/her ability to do work or to read.
Week 5
Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)
Clearance is the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported.
Baseline through 5 weeks
Time to Response
Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 50% of the participants at risk had at least 30% response was reported.
Baseline through 5 weeks
Number of Participants With Neurological Treatment Emergent Adverse Events (TEAEs)
The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the "Nervous system disorders" system organ class was summarized. A listing of serious AEs (SAEs) and other non-serious AEs is located in the Reported Adverse Event module.
Baseline through 5 weeks
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tustin
California
92780
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
DeLand
Florida
32720
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fort Myers
Florida
33912
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jacksonville
Florida
32216
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
St Louis
Missouri
63141
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Oklahoma City
Oklahoma
73109
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dallas
Texas
75231
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aguascalientes
20217
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mexico City
11850
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Monterrey
64000
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hato Rey
00917
Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ponce
00716
Puerto Rico
FG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
FG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
FG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
FG00089 subjects
FG00145 subjects
FG00243 subjects
FG00349 subjects
FG00447 subjects
COMPLETED
FG00078 subjects
FG00136 subjects
FG00225 subjects
FG00336 subjects
FG00427 subjects
NOT COMPLETED
FG00011 subjects
FG0019 subjects
FG00218 subjects
FG00313 subjects
FG00420 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0017 subjects
FG00214 subjects
FG00310 subjects
FG00417 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Entry Criteria Exclusion
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Sponsor Decision
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Study Period 3: 1-Week Washout Phase
Type
Comment
Milestone Data
STARTED
FG00078 subjects
FG00136 subjects
FG00225 subjects
FG00336 subjects
FG00427 subjects
COMPLETED
FG00078 subjects
FG00136 subjects
FG00225 subjects
FG00335 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
BG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
BG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
BG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
BG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00089
BG00145
BG00243
BG00349
BG00447
BG005273
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00055.32± 10.00
BG00156.89± 8.19
BG00256.95± 8.35
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00037
BG00117
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
American Indian or Alaskan Native
Title
Measurements
BG0007
BG0014
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00057
BG00129
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks
This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG003
LY545694 105 mg
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00078
OG00126
OG00235
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.08± 0.22
OG001-2.22± 0.36
OG002-2.45± 0.32
OG003
Secondary
Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks
This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
Secondary
Change From Baseline in Weekly Mean Worst Daily Pain Severity Score at 5 Weeks
This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
Secondary
Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score
This scale measured the number of participants with a 30% reduction in weekly mean 24-hour APS score from baseline to endpoint. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population.
Posted
Number
participants
Baseline through 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
Secondary
Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks
Average BPI-I measured self-reported degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
Secondary
Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks
BPI-S measured self-reported severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
Secondary
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks
CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
Secondary
Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks
PGI-I measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.
Posted
Least Squares Mean
Standard Error
units on a scale
Week 5
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
Secondary
Change From Baseline in Short-form McGill Pain Questionnaire (SF-MPQ) Sensory Subscale Score at 5 Weeks
SF-MPQ consisted of 11 sensory descriptors describing pain that were rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
Secondary
Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks
ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represent better sleep.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
Secondary
Change From Baseline in Neuropathy-Specific Quality of Life (NeuroQoL) Questionnaire Score at 5 Weeks
NeuroQoL had 29 items: 13 assessed specific somatic experiences (pain, lost/reduced feeling, and diffuse sensory-motor symptoms); 14 assessed specific functional, social, and emotional experiences (restrictions in daily living activities, disruptions in social relationships, and emotional distress); 2 items assessed QoL and overall satisfaction. Items reported on a 5-point scale (never/not at all to all of the time/very much). Higher mean scores=more severe symptoms/greater disruption in functioning. First 27 items also associate with 3-point bothersome/importance scale (1=none to 3=very).
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
Secondary
Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks
The SF-36 Health Status Survey was a generic, health-related scale assessing participants' quality of life on 8 domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health) and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
Secondary
Change From Baseline of European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score
The EQ-5D was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
Secondary
Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks
The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
Secondary
Number of Participants Who Discontinued Due to Adverse Events (AEs) During the Therapy (Double-blind) Phase and 1-Week Washout (Follow-up) Phase
Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.
The safety analysis population included all 273 participants randomized to study drug.
Posted
Number
participants
Baseline through 6 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
Secondary
Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values
The number of participants by treatment group who had abnormal high or low laboratory values was reported by the investigator and summarized as serious adverse events (SAEs) from the "Investigations" system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module.
The safety analysis population included all 273 participants randomized to study drug.
Posted
Number
participants
Baseline through 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
Secondary
Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks
Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Least Squares Mean
Standard Error
millimeters of mercury (mmHg)
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
Secondary
Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks
Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Least Squares Mean
Standard Error
beats per minute (bpm)
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
Secondary
Number of Participants With Electrocardiogram Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas
The number of participants having QTcF and QTcB change ≥ 30 msec was summarized.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Number
participants
Baseline through 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
Secondary
Percentage of Participants With Reported Hypoglycemic Events
Percentage of participants who reported hypoglycemic (lower than normal level of blood glucose) episodes was summarized as other non-serious adverse events (AEs) from the "Investigations" system organ class (preferred term = hypoglycemia). A listing of AEs is located in the Reported Adverse Event module.
The safety analysis population included all 273 participants randomized to study drug.
Posted
Number
percentage of participants
Baseline through 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG003
LY545694 105 mg
Secondary
Change From Baseline in Overall Total Quick Inventory of Depressive Symptomatology (QIDS) Score
The QIDS was a 16-item patient-rated measure of depressive symptomatology. Each item had a 0 to 3 point scale. The total score ranged from 0 to 27 with higher scores indicative of greater severity. QIDS was calculated by summing the scores from the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) major depressive disorder criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
Secondary
Number of Participants With Suicidal Behaviors and Ideations
The Columbia Suicide Severity Rating Scale (C-SSRS) captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations were provided. Suicidal behavior = a "yes" answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation = a "yes" answer to any 1 of 5 suicidal ideation questions, which included the wish to be dead and 4 different categories of active suicidal ideation.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Number
participants
Baseline through week 5
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
Secondary
Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks
This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, follow-up questions rated the degree to which the issue impaired his/her ability to do work or to read.
The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.
Posted
Number
participants
Week 5
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
Secondary
Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)
Clearance is the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported.
The PK dataset for population modeling consisted of quantifiable plasma LY545694 and Compound 64538 concentrations from participants following daily oral doses of LY545694 21 mg to LY545694 105 mg.
Posted
Geometric Mean
95% Confidence Interval
Liters per hour (L/hr)
Baseline through 5 weeks
ID
Title
Description
OG000
LY545694 Clearance (CLp)
Plasma LY545694 concentrations were obtained following daily oral doses of LY545694 21 mg to LY545694 105 mg.
OG001
Compound 645838 (CLm)
Plasma Compound 645838 concentrations were obtained following daily oral doses of LY545694 21 mg to 105 mg.
Units
Counts
Participants
Secondary
Time to Response
Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 50% of the participants at risk had at least 30% response was reported.
The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.
Posted
Number
time (days)
Baseline through 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
Secondary
Number of Participants With Neurological Treatment Emergent Adverse Events (TEAEs)
The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the "Nervous system disorders" system organ class was summarized. A listing of serious AEs (SAEs) and other non-serious AEs is located in the Reported Adverse Event module.
The safety analysis population included all 273 participants randomized to study drug.
Posted
Number
participants
Baseline through 5 weeks
ID
Title
Description
OG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
OG001
Pregabalin
Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
OG002
LY545694 21 mg
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks
LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1
49
43
49
EG003
LY545694 105 mg
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1
47
40
47
EG004
Pregabalin
Pregabalin thrice daily (TID) oral (po) for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6
0
45
31
45
EG005
Placebo Washout
A one-week washout period in which no placebo was taken.
0
89
15
89
EG006
LY545694 21 mg Washout
A one-week washout period in which no LY545694 21 mg was taken.
0
43
4
43
EG007
LY545694 49 mg Washout
A one-week washout period in which no LY545694 49 mg was taken.
0
49
7
49
EG008
LY545694 105 mg Washout
A one-week washout period in which no LY545694 105 mg was taken.
1
47
7
47
EG009
Pregabalin Washout
A one-week washout period in which no pregabalin was taken.
0
45
6
45
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial infarction
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG0030 events0 affected47 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected43 at risk
EG0070 events0 affected49 at risk
EG0081 events1 affected47 at risk
EG0090 events0 affected45 at risk
Vomiting
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Alanine aminotransferase abnormal
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Aspartate aminotransferase abnormal
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG0030 events0 affected47 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected43 at risk
EG0070 events0 affected49 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected45 at risk
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Bundle branch block left
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Nodal rhythm
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0012 events2 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Hyperacusis
Ear and labyrinth disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0011 events1 affected43 at risk
EG0023 events2 affected49 at risk
EG003
Blepharitis
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Blepharospasm
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Dry eye
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Macular oedema
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Phosphenes
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Photophobia
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Retinal exudates
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Retinopathy
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Uveitis
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Vision blurred
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected89 at risk
EG0014 events4 affected43 at risk
EG0022 events2 affected49 at risk
EG003
Visual impairment
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0003 events2 affected89 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0012 events2 affected43 at risk
EG0022 events2 affected49 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0008 events7 affected89 at risk
EG0013 events3 affected43 at risk
EG0024 events4 affected49 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Faecal incontinence
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0023 events3 affected49 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0012 events1 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0003 events3 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Lip disorder
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG00012 events11 affected89 at risk
EG00114 events12 affected43 at risk
EG00217 events15 affected49 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0004 events4 affected89 at risk
EG0017 events6 affected43 at risk
EG00213 events12 affected49 at risk
EG003
Asthenia
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0025 events3 affected49 at risk
EG003
Chills
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Fatigue
General disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected89 at risk
EG0011 events1 affected43 at risk
EG0023 events3 affected49 at risk
EG003
Feeling cold
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Feeling jittery
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Gait disturbance
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Irritability
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Malaise
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Oedema peripheral
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Pain
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Temperature intolerance
General disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Food allergy
Immune system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Cystitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Gastroenteritis bacterial
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Influenza
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0003 events3 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Localised infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Tinea cruris
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0003 events3 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Viral infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Wound infection
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Meniscus lesion
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Blood bicarbonate abnormal
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Blood bicarbonate increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Blood calcium increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Blood glucose decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Blood glucose increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected89 at risk
EG0012 events2 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Blood pressure diastolic decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Blood pressure increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Blood pressure systolic decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Blood urea increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Electrocardiogram poor r-wave progression
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Electrocardiogram qrs complex prolonged
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Electrocardiogram t wave abnormal
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Glucose urine present
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Grip strength decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Heart rate increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Monofilament pressure perception test abnormal
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Neurological examination abnormal
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Qrs axis abnormal
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Red blood cell sedimentation rate increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Rheumatoid factor increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Weight decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Weight increased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected89 at risk
EG0014 events4 affected43 at risk
EG0029 events9 affected49 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Food intolerance
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0003 events3 affected89 at risk
EG0012 events2 affected43 at risk
EG0025 events5 affected49 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Hypocholesterolaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Salt craving
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Vitamin d deficiency
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0004 events4 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0024 events3 affected49 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Posture abnormal
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Scoliosis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0013 events3 affected43 at risk
EG0022 events2 affected49 at risk
EG003
Coordination abnormal
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Decreased vibratory sense
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected89 at risk
EG0015 events5 affected43 at risk
EG0028 events8 affected49 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG00013 events11 affected89 at risk
EG0012 events1 affected43 at risk
EG0022 events2 affected49 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Hyporeflexia
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Monoparesis
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Motor dysfunction
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Muscle contractions involuntary
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Narcolepsy
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0012 events2 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Poor quality sleep
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0012 events2 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Psychomotor hyperactivity
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0002 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Sensory loss
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0004 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0012 events2 affected43 at risk
EG0025 events5 affected49 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Syncope
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Tremor
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG00211 events10 affected49 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Apathy
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Bradyphrenia
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected89 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Depression
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0022 events2 affected49 at risk
EG003
Depressive symptom
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Dissociation
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Dysthymic disorder
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Elevated mood
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Emotional disorder
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Euphoric mood
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Generalised anxiety disorder
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Hypomania
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Initial insomnia
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0011 events1 affected43 at risk
EG0027 events7 affected49 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Terminal insomnia
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Bladder sphincter atony
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Incontinence
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0012 events2 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0012 events2 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0022 events2 affected49 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Hyperoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0022 events2 affected49 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Pleural rub
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Postnasal drip
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0002 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Debridement
Surgical and medical procedures
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Renal stone removal
Surgical and medical procedures
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Skin graft
Surgical and medical procedures
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Tumour excision
Surgical and medical procedures
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected89 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected49 at risk
EG003
Hot flush
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected49 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected89 at risk
EG0010 events0 affected43 at risk
EG0022 events2 affected49 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
D003929
Diabetic Neuropathies
Ancestor Terms
ID
Term
D010523
Peripheral Nervous System Diseases
D009468
Neuromuscular Diseases
D009422
Nervous System Diseases
D048909
Diabetes Complications
D003920
Diabetes Mellitus
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069583
Pregabalin
C000593718
dasolampanel etibutil
Ancestor Terms
ID
Term
D005680
gamma-Aminobutyric Acid
D000613
Aminobutyrates
D002087
Butyrates
D000144
Acids, Acyclic
D002264
Carboxylic Acids
D009930
Organic Chemicals
D000596
Amino Acids
D000602
Amino Acids, Peptides, and Proteins
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
0 subjects
0 subjects
1 subjects
1 subjects
0 subjects
0 subjects
26 subjects
1 subjects
1 subjects
FG0040 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
58.59
± 7.71
BG00456.47± 7.77
BG00556.62± 8.71
20
BG00325
BG00419
BG005118
Male
BG00052
BG00128
BG00223
BG00324
BG00428
BG005155
2
BG0034
BG0042
BG00519
Asian
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
BG0052
Black or African American
Title
Measurements
BG00010
BG0016
BG0029
BG0034
BG0048
BG00537
Multiple
Title
Measurements
BG0001
BG0010
BG0021
BG0031
BG0041
BG0054
White
Title
Measurements
BG00071
BG00135
BG00230
BG00340
BG00435
BG005211
28
BG00329
BG00428
BG005171
Mexico
Title
Measurements
BG00026
BG00113
BG00212
BG00316
BG00416
BG00583
Puerto Rico
Title
Measurements
BG0006
BG0013
BG0023
BG0034
BG0043
BG00519
30
-2.42
± 0.33
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00078
OG00135
OG00226
OG00335
OG00430
Title
Denominators
Categories
Title
Measurements
OG000-2.31± 0.23
OG001-2.75± 0.33
OG002-2.25± 0.37
OG003-2.54± 0.33
OG004-2.21± 0.34
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00078
OG00135
OG00226
OG00335
OG00430
Title
Denominators
Categories
Title
Measurements
OG000-2.27± 0.25
OG001-2.87± 0.35
OG002-2.57± 0.40
OG003-2.77± 0.35
OG004-2.67± 0.37
OG003
LY545694 105 mg
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00089
OG00142
OG00248
OG00347
Title
Denominators
Categories
Title
Measurements
OG00038
OG00118
OG00221
OG00321
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00079
OG00137
OG00226
OG00335
OG00430
Title
Denominators
Categories
Title
Measurements
OG000-2.73± 0.25
OG001-2.81± 0.34
OG002-2.31± 0.39
OG003-2.73± 0.34
OG004-2.30± 0.36
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00079
OG00137
OG00226
OG00335
OG00430
Title
Denominators
Categories
BPI-S Worst Pain
Title
Measurements
OG000-2.57± 0.29
OG001-3.54± 0.40
OG002-3.49± 0.47
OG003-2.94± 0.41
OG004-3.13± 0.44
BPI-S Least Pain
Title
Measurements
OG000-1.76± 0.26
OG001-2.44± 0.35
OG002-1.99± 0.40
OG003
BPI-S Average Pain
Title
Measurements
OG000-2.08± 0.26
OG001-2.92± 0.36
OG002-2.79± 0.41
OG003
BPI-S Current Pain
Title
Measurements
OG000-2.44± 0.28
OG001-3.06± 0.38
OG002-2.66± 0.44
OG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00079
OG00137
OG00226
OG00335
OG00430
Title
Denominators
Categories
Title
Measurements
OG000-1.07± 0.11
OG001-1.02± 0.15
OG002-1.28± 0.18
OG003-1.07± 0.15
OG004-1.03± 0.16
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00079
OG00137
OG00226
OG00335
OG00430
Title
Denominators
Categories
Title
Measurements
OG0002.58± 0.13
OG0012.28± 0.18
OG0022.37± 0.20
OG0032.63± 0.18
OG0042.41± 0.19
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00079
OG00136
OG00226
OG00335
OG00430
Title
Denominators
Categories
Title
Measurements
OG000-8.20± 0.73
OG001-8.60± 1.01
OG002-8.93± 1.20
OG003-8.95± 1.02
OG004-7.89± 1.10
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00078
OG00135
OG00226
OG00332
OG00430
Title
Denominators
Categories
Title
Measurements
OG0000.76± 0.08
OG0010.88± 0.11
OG0020.67± 0.13
OG0030.51± 0.12
OG0040.55± 0.12
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00089
OG00145
OG00240
OG00345
OG00444
Title
Denominators
Categories
Title
Measurements
OG000-0.56± 0.11
OG001-0.49± 0.15
OG002-0.58± 0.16
OG003-0.59± 0.15
OG004-0.31± 0.15
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00088
OG00145
OG00240
OG00345
OG00444
Title
Denominators
Categories
Title
Measurements
OG0007.51± 0.94
OG00110.70± 1.26
OG0028.16± 1.32
OG0035.78± 1.24
OG0046.33± 1.26
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00088
OG00145
OG00240
OG00345
OG00444
Title
Denominators
Categories
Title
Measurements
OG0000.09± 0.02
OG0010.09± 0.02
OG0020.11± 0.02
OG0030.05± 0.02
OG0040.07± 0.02
OG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00088
OG00145
OG00240
OG00344
OG00444
Title
Denominators
Categories
Title
Measurements
OG000-2.96± 0.70
OG001-2.58± 0.94
OG002-2.63± 0.99
OG003-1.97± 0.95
OG004-3.04± 0.95
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00089
OG00145
OG00243
OG00349
OG00447
Title
Denominators
Categories
Therapy (Double-blind) Phase
Title
Measurements
OG0005
OG0017
OG00214
OG00310
OG00417
1-Week Washout (Follow-up) Phase
Title
Measurements
OG0000
OG0010
OG0020
OG003
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00089
OG00145
OG00243
OG00349
OG00447
Title
Denominators
Categories
Alanine aminotransferase (ALT) abnormal
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
Aspartate aminotransferase (AST) abnormal
Title
Measurements
OG0000
OG0010
OG0020
OG003
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00079
OG00137
OG00226
OG00335
OG00430
Title
Denominators
Categories
Systolic Blood Pressure (mmHg)
Title
Measurements
OG000-1.82± 1.37
OG001-3.18± 1.93
OG0020.22± 2.26
OG003-0.24± 1.96
OG0040.08± 2.10
Diastolic Blood Pressure (mmHg)
Title
Measurements
OG000-0.87± 0.88
OG001-3.60± 1.25
OG002-0.07± 1.46
OG003
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00079
OG00137
OG00226
OG00335
OG00430
Title
Denominators
Categories
Title
Measurements
OG000-1.06± 1.05
OG001-3.60± 1.49
OG0020.87± 1.72
OG0031.47± 1.51
OG0041.66± 1.61
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00078
OG00141
OG00236
OG00342
OG00436
Title
Denominators
Categories
QTcB ≥30 msec
Title
Measurements
OG0004
OG0010
OG0022
OG0031
OG0041
QTcF ≥30 msec
Title
Measurements
OG0003
OG0010
OG0021
OG003
LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00089
OG00143
OG00249
OG00347
Title
Denominators
Categories
Title
Measurements
OG0001.12
OG0010.00
OG0020.00
OG0032.13
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00089
OG00145
OG00243
OG00349
OG00447
Title
Denominators
Categories
Title
Measurements
OG000-1.96± 0.22
OG001-1.49± 0.31
OG002-0.69± 0.34
OG003-0.46± 0.31
OG0040.20± 0.32
LY545694 21 milligrams (mg) BID po for 1 week.
OG003
LY545694 49 mg
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00089
OG00145
OG00243
OG00349
OG00447
Title
Denominators
Categories
Suicidal behaviors
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
Suicidal ideations
Title
Measurements
OG0001
OG0010
OG0021
OG003
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00079
OG00137
OG00226
OG00335
OG00430
Title
Denominators
Categories
YES
Title
Measurements
OG0008
OG0018
OG0023
OG0033
OG0044
NO
Title
Measurements
OG00071
OG00129
OG00223
OG003
OG000115
OG001118
Title
Denominators
Categories
Title
Measurements
OG00079.1(68.7 to 91.9)
OG00139.8(35.8 to 44.8)
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Units
Counts
Participants
OG00089
OG00145
OG00242
OG00348
OG00447
Title
Denominators
Categories
Title
Measurements
OG00036
OG00130
OG00230
OG00330
OG00430
OG004
LY545694 105 mg
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.