An Efficacy Study of Compound LY2624803 in the Treatment... | NCT00784875 | Trialant
NCT00784875
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Feb 29, 2012Estimated
Enrollment
643Actual
Phase
Phase 2
Conditions
Primary Insomnia
Secondary Insomnia
Interventions
LY2624803
LY2624803
Placebo
zolpidem
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00784875
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
12063
Secondary IDs
ID
Type
Description
Link
I2K-MC-ZZAD
Other Identifier
Eli Lilly and Company
Brief Title
An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
Official Title
A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study of the Safety and Efficacy of LY2624803 in Outpatients With Insomnia
Acronym
SLUMBER
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jan 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
Oct 2008
Primary Completion Date
Feb 2010Actual
Completion Date
Feb 2010Actual
First Submitted Date
Oct 31, 2008
First Submission Date that Met QC Criteria
Oct 31, 2008
First Posted Date
Nov 4, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 17, 2011
Results First Submitted that Met QC Criteria
Jan 30, 2012
Results First Posted Date
Feb 29, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 9, 2010
Certification/Extension First Submitted that Passed QC Review
Dec 9, 2010
Certification/Extension First Posted Date
Dec 15, 2010Estimated
Last Update Submitted Date
Jan 30, 2012
Last Update Posted Date
Feb 29, 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)
Yes
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 compare an investigational drug (LY2624803) with placebo and with zolpidem in the treatment of outpatients with chronic insomnia.
Detailed Description
Outpatients with chronic insomnia who participate in this study will be treated in each of four 2-week treatment periods with bedtime doses of either placebo, zolpidem, LY2624803 1 mg, or LY2624803 3 mg. Neither patients nor investigators will be told what treatments are being given in any treatment period. A patient who completes all four treatment periods will be treated with placebo in 1, 2, or 3 of the periods; with zolpidem in 0, 1, or 2 of the periods; and with LY2624803 in either 1 or 2 of the periods. No patient will receive placebo for all four of the 2-week treatment periods. All patients will receive LY2624803 for at least one of the four 2-week treatment periods. During each treatment period, patients will record information each morning about their sleep the night before, and each evening about their functioning since waking up. Patients will also wear wrist actigraphy devices to record their physical activity. At the conclusion of each treatment period, patients will answer questions about their sleep, functioning, health, and relative preference for treatments.
Conditions Module
Conditions
Primary Insomnia
Secondary Insomnia
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
643Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Period A
Experimental
2-week double-blind placebo lead-in period. Period A is the first of four 2-week treatment periods.
Drug: Placebo
Period B
Experimental
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period B is the second of four 2-week treatment periods.
Drug: LY2624803
Drug: Placebo
Drug: zolpidem
Period C
Experimental
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period C is the third of four 2-week treatment periods.
Drug: LY2624803
Drug: Placebo
Drug: zolpidem
Period D
Experimental
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period D is the fourth of four 2-week treatment periods.
Drug: LY2624803
Drug: Placebo
Drug: zolpidem
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2624803
Drug
1 mg, oral capsule, once nightly before bedtime
Period B
Period C
Period D
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
Baseline, 2 weeks
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint
Unwanted time awake (minutes awake [MA] before sleep [between turning off the lights to first falling asleep], MA during sleep, MA after sleep before getting out of bed). Minimum would be 0; no defined maximum. The higher the number, the more the unwanted time awake. Calculated in minutes from participant-reported daily sleep questionnaire averaged (Avg.) across Period B. Change score subtracts Period B Avg. from Period A Avg. (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group, and insomnia type.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients must be between 18 and 85 years of age, with a stable living situation
Clinical diagnosis of either primary insomnia or "secondary" insomnia (comorbid with depression, anxiety, and/or medical illness)
Insomnia systems must be at least moderate in severity within the month prior to study entry, and must include difficulty staying asleep and/or problems with awakening earlier than desired
Psychiatric and medical conditions present must be stable over the 3 months prior to study entry, and not expected to worsen significantly or require hospitalization during participation in the study
Ongoing treatments for psychiatric and medical conditions present must have been stable for the 3 months prior to study entry, and must be expected to remain stable during participation in the study
Patients must be willing to abstain from taking medications (other than study drug) to help them sleep during participation in the study
Patients must be willing to consistently spend at least 7 hours each night either sleeping or trying to sleep during participation in the study
Patients must be able to speak and read English and be capable of using a computer with a web browser (computers with internet connections will be provided to patients who need them)
Exclusion Criteria:
Unusual or unstable sleep/wake schedule, such as with rotating shift work
Severe or unstable psychiatric or medical illness
Suicidal ideation
Substance abuse
Known obstructive sleep apnea, restless leg syndrome, or periodic limb movement disorder
History of seizures
Body Mass Index > 33
Clinically significant abnormality in clinical chemistry, hematology, urinalysis, and/or electrocardiogram
Anticipated inability to regularly use a medication which might reduce motor or cognitive functioning during sleeping hours, such as a person who might often need to be "on call", drive a car, or be responsible for the care of another person during sleeping hours
Contraindication to zolpidem
History of breast cancer
An estimated glomerular filtration rate (GFR; an index of renal function) that is <30 mL/min at study entry
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
85 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.
Birmingham
Alabama
35213
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
None of Cohort 1 participants completed the study and few progressed beyond Period B. The efficacy analyses were conducted using data from Cohort 2 participants only. Participant flow includes participants from both cohorts.
Recruitment Details
LY2624803 was placed on clinical hold by Food and Drug Administration (FDA) on 18 December 2008. The FDA lifted the clinical hold effective 05 May 2009. For analysis purposes, participants who entered into study during 2008 were designated as Cohort 1, whereas participants who entered into study after 2008 were designated as Cohort 2.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
LY2624803 1 mg
Participants received LY2624803 1 mg in a 2-week treatment period.
FG001
LY2624803 3 mg
Participants received LY2624803 3 mg in a 2-week treatment period.
Periods
Title
Milestones
Reasons Not Completed
Period A - Baseline
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
LY2624803
Drug
3 mg, oral capsule, once nightly before bedtime
Period B
Period C
Period D
Placebo
Drug
matching placebo (capsule or tablet), once nightly before bedtime
Period A
Period B
Period C
Period D
zolpidem
Drug
5 or 10 mg, oral tablet, once nightly before bedtime
Period B
Period C
Period D
Baseline, 2 weeks
Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint
Elicited from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
Baseline, 2 weeks
Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint
Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
Baseline, 2 weeks
Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint
Calculated as (TIB-TTA)/TIB where TIB is time in bed and TTA is total unwanted time awake. Higher score indicates better sleep efficiency. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
Baseline, 2 weeks
Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint
Assessment of Sleep Quality (ASQ) scale is asked in the participant-reported daily sleep questionnaire; 8 items on 4 point Likert scale with a range of 0 to 24. Sleep experience score ranges from 0-9; awakening experience ranges from 0-15. The higher the score, the better the sleep. Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
Baseline, 2 weeks
Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint
DCIQ scale is asked in the participant-reported daily evening questionnaire; 5 point Likert scale with minimum of 0 and maximum of 44 (the higher the score, the more consequences of insomnia). Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
Baseline, 2 weeks
Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint
The ISI is a brief self-report instrument that measures a participant's perception of his or her insomnia. 7 questions on 5-point Likert scale with minimum of 0 and maximum of 28. The higher the score, the more severe the insomnia. It was collected at the bi-weekly office visits. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
Baseline, 2 weeks
Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint
The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary)
Baseline, 2 weeks
Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint
The EuroQoL Questionnaire-5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. The score ranges 0-100. The higher score indicates a better health state perceived by the participant. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
Baseline, 2 weeks
Treatment Satisfaction as Measured by the Participant Drug Preference Question
After study Periods A, and B, participants were asked to rate their experience with the treatment they had just completed. Data are presented as percentage of participants preferring the treatment received in Period A (placebo) or treatment received in Period B.
Baseline (Period A) and 2 weeks (Period B)
Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.
2 weeks
Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.
2 weeks
Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.
Baseline, 2 weeks
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type
Number of participants with AEs and SAEs. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.
Baseline through 8 weeks
Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.
Baseline, 2 weeks
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group
Number of participants with AEs and SAEs. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.
Baseline through 8 weeks
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Treatment Emergent Adverse Events (TEAEs) are defined as AEs that first occurred or worsened during the treatment period. TEAEs are summarized by study period and treatment group. TEAEs do not distinguish whether the events were deemed serious. A summary of non-serious AEs is located in the Reported Adverse Event module.
Baseline through 8 weeks
Number of Participants With Serious Adverse Events (SAEs)
SAEs do not distinguish whether the events are treatment-emergent. A summary of SAEs is located in the Reported Adverse Event module.
Baseline through 8 weeks
Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Baseline, 2 weeks of treatment over 8 weeks
Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for pulse rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Baseline, 2 weeks of treatment over 8 weeks
Change From Baseline in Weight at Each 2-week Treatment Endpoint
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for body weight are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Baseline, 2 weeks of treatment over 8 weeks
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Summary of number of participants with abnormal clinical chemistry, hematology and urinalysis laboratory results. A participant is included in the abnormal category if he/she experienced a result outside the normal reference ranges based on Lilly's reference range in the current period. All analytes have both lower and upper limits. The abnormal number includes both low (below normal range) and high (above normal range).
2 weeks of treatment over 8 weeks
Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for heart rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Baseline, 2 weeks of treatment over 8 weeks
Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF is the QT interval corrected for heart rate using Fridericia formula. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Baseline, 2 weeks of treatment over 8 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.
Glendale
Arizona
85306
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.
Mesa
Arizona
85210
United States
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Little Rock
Arkansas
72211
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.
Burbank
California
91505
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.
Glendale
California
91206
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.
Los Angeles
California
90048
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.
Oceanside
California
92056
United States
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Pismo Beach
California
93449
United States
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San Diego
California
92123
United States
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Santa Rosa
California
95405
United States
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Torrance
California
90502
United States
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Denver
Colorado
80239
United States
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Fruitland Park
Florida
34731
United States
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Hialeah
Florida
33012
United States
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Lauderdale Lakes
Florida
33319
United States
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Maitland
Florida
32751
United States
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Naples
Florida
34110
United States
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Pembroke Pines
Florida
33024
United States
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St. Petersburg
Florida
33707
United States
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Tampa
Florida
33607
United States
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Atlanta
Georgia
30342
United States
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Suwanee
Georgia
30024
United States
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Oak Brook
Illinois
60523
United States
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Springfield
Illinois
62711
United States
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Terre Haute
Indiana
47802
United States
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Crestview Hills
Kentucky
41017
United States
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Chevy Chase
Maryland
20815
United States
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Wellesley Hills
Massachusetts
02481
United States
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Sterling Heights
Michigan
48314
United States
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Florissant
Missouri
63033
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.
Las Vegas
Nevada
89146
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.
Brooklyn
New York
11235
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.
The Bronx
New York
10454
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.
Hickory
North Carolina
28601
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.
Raleigh
North Carolina
27612
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.
Winston-Salem
North Carolina
27103
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.
Cincinnati
Ohio
45246
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.
Cleveland
Ohio
44122
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.
Portland
Oregon
97210
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.
Jenkintown
Pennsylvania
19046
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.
Lincoln
Rhode Island
02865
United States
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Anderson
South Carolina
29621
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.
Memphis
Tennessee
38119
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.
Austin
Texas
78756
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.
San Antonio
Texas
78229
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.
Bellevue
Washington
98004
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.
Lakewood
Washington
98499
United States
FG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
FG003
Placebo
Participants received placebo in a 2-week treatment period.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003643 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003461 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003182 subjects
Type
Comment
Reasons
Entry Criteria Not Met
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0035 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0038 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00325 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00327 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003113 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
Period B - Efficacy Endpoint
Type
Comment
Milestone Data
STARTED
FG000114 subjects
FG001113 subjects
FG002117 subjects
FG003117 subjects
Cohort 2
FG000102 subjects
FG001102 subjects
FG002102 subjects
FG003101 subjects
COMPLETED
FG000100 subjects
FG001101 subjects
FG00296 subjects
FG00398 subjects
NOT COMPLETED
FG00014 subjects
FG00112 subjects
FG00221 subjects
FG00319 subjects
Type
Comment
Reasons
Entry Criteria Not Met
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG003
Period C
Type
Comment
Milestone Data
STARTED
FG000103 subjects
FG00197 subjects
FG00297 subjects
FG00398 subjects
COMPLETED
FG00096 subjects
FG00191 subjects
FG00284 subjects
FG00391 subjects
NOT COMPLETED
FG0007 subjects
FG0016 subjects
FG00213 subjects
FG0037 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0024 subjects
FG003
Period D
Type
Comment
Milestone Data
STARTED
FG00091 subjects
FG00189 subjects
FG00294 subjects
FG00388 subjects
COMPLETED
FG00086 subjects
FG00185 subjects
FG00288 subjects
FG00387 subjects
NOT COMPLETED
FG0005 subjects
FG0014 subjects
FG0026 subjects
FG0031 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
BG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
BG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
BG003
Placebo
Participants received placebo in Period B (2-week treatment period).
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000102
BG001102
BG002102
BG003101
BG004407
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
BG00052.81± 14.07
BG00152.77± 14.73
BG00250.65± 15
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00066
BG00152
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Caucasian
Title
Measurements
BG00075
BG00174
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG000102
BG001102
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 Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
minutes
Baseline, 2 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
OG003
Placebo
Participants received placebo in Period B (2-week treatment period).
Units
Counts
Participants
OG000102
OG001102
OG002102
OG003
Title
Denominators
Categories
Title
Measurements
OG00030.16± 5.300
OG00137.33± 5.186
OG00250.63± 5.186
OG003
Secondary
Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint
Unwanted time awake (minutes awake [MA] before sleep [between turning off the lights to first falling asleep], MA during sleep, MA after sleep before getting out of bed). Minimum would be 0; no defined maximum. The higher the number, the more the unwanted time awake. Calculated in minutes from participant-reported daily sleep questionnaire averaged (Avg.) across Period B. Change score subtracts Period B Avg. from Period A Avg. (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group, and insomnia type.
All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
minutes
Baseline, 2 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
Secondary
Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint
Elicited from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
number of awakenings
Baseline, 2 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
OG003
Placebo
Secondary
Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint
Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
minutes
Baseline, 2 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
OG003
Placebo
Secondary
Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint
Calculated as (TIB-TTA)/TIB where TIB is time in bed and TTA is total unwanted time awake. Higher score indicates better sleep efficiency. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
ratio
Baseline, 2 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
OG003
Placebo
Secondary
Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint
Assessment of Sleep Quality (ASQ) scale is asked in the participant-reported daily sleep questionnaire; 8 items on 4 point Likert scale with a range of 0 to 24. Sleep experience score ranges from 0-9; awakening experience ranges from 0-15. The higher the score, the better the sleep. Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 2 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
Secondary
Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint
DCIQ scale is asked in the participant-reported daily evening questionnaire; 5 point Likert scale with minimum of 0 and maximum of 44 (the higher the score, the more consequences of insomnia). Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 2 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
Secondary
Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint
The ISI is a brief self-report instrument that measures a participant's perception of his or her insomnia. 7 questions on 5-point Likert scale with minimum of 0 and maximum of 28. The higher the score, the more severe the insomnia. It was collected at the bi-weekly office visits. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 2 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
Secondary
Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint
The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary)
All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 2 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
Secondary
Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint
The EuroQoL Questionnaire-5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. The score ranges 0-100. The higher score indicates a better health state perceived by the participant. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).
All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 2 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
Secondary
Treatment Satisfaction as Measured by the Participant Drug Preference Question
After study Periods A, and B, participants were asked to rate their experience with the treatment they had just completed. Data are presented as percentage of participants preferring the treatment received in Period A (placebo) or treatment received in Period B.
All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Number
percentage of participants
Baseline (Period A) and 2 weeks (Period B)
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
OG003
Placebo
Participants received placebo in Period B (2-week treatment period).
Secondary
Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.
All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Number
percentage of participants
2 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
OG003
Placebo
Participants received placebo in Period B (2-week treatment period).
Secondary
Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.
All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Number
percentage of participants
2 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
OG003
Placebo
Participants received placebo in Period B (2-week treatment period).
Secondary
Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.
Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.
Posted
Least Squares Mean
Standard Error
minutes
Baseline, 2 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
OG003
Placebo
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type
Number of participants with AEs and SAEs. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.
Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.
Posted
Number
participants
Baseline through 8 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in a 2-week treatment period.
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in a 2-week treatment period.
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
OG003
Placebo
Participants received placebo in a 2-week treatment period.
Secondary
Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.
Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.
Posted
Least Squares Mean
Standard Error
minutes
Baseline, 2 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in Period B (2-week treatment period).
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in Period B (2-week treatment period).
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
OG003
Placebo
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group
Number of participants with AEs and SAEs. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.
Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.
Posted
Least Squares Mean
Standard Error
participants
Baseline through 8 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in a 2-week treatment period.
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in a 2-week treatment period.
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
OG003
Placebo
Participants received placebo in a 2-week treatment period.
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Treatment Emergent Adverse Events (TEAEs) are defined as AEs that first occurred or worsened during the treatment period. TEAEs are summarized by study period and treatment group. TEAEs do not distinguish whether the events were deemed serious. A summary of non-serious AEs is located in the Reported Adverse Event module.
All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.
Posted
Number
participants
Baseline through 8 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in a 2-week treatment period.
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in a 2-week treatment period.
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
OG003
Placebo
Participants received placebo in a 2-week treatment period.
Secondary
Number of Participants With Serious Adverse Events (SAEs)
SAEs do not distinguish whether the events are treatment-emergent. A summary of SAEs is located in the Reported Adverse Event module.
All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.
Posted
Number
participants
Baseline through 8 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in a 2-week treatment period.
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in a 2-week treatment period.
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
OG003
Placebo
Participants received placebo in a 2-week treatment period.
Secondary
Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
mmHg
Baseline, 2 weeks of treatment over 8 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in a 2-week treatment period.
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in a 2-week treatment period.
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
OG003
Placebo
Participants received placebo in a 2-week treatment period.
Secondary
Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for pulse rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
beats per minute
Baseline, 2 weeks of treatment over 8 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in a 2-week treatment period.
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in a 2-week treatment period.
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
OG003
Placebo
Participants received placebo in a 2-week treatment period.
Secondary
Change From Baseline in Weight at Each 2-week Treatment Endpoint
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for body weight are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
kilogram
Baseline, 2 weeks of treatment over 8 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in a 2-week treatment period.
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in a 2-week treatment period.
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
OG003
Placebo
Participants received placebo in a 2-week treatment period.
Secondary
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Summary of number of participants with abnormal clinical chemistry, hematology and urinalysis laboratory results. A participant is included in the abnormal category if he/she experienced a result outside the normal reference ranges based on Lilly's reference range in the current period. All analytes have both lower and upper limits. The abnormal number includes both low (below normal range) and high (above normal range).
All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had endpoint value. For LY2624803 1 mg, LY2624803 3 mg, Zolpidem 5 or 10 mg, and Placebo, the Number of Participants Analyzed were as follows: Period B: N=114, 113,117, 117; Period C: N=103, 97, 97, 98; and Period D: N=91, 89, 94, 88.
Posted
Number
participants
2 weeks of treatment over 8 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in a 2-week treatment period.
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in a 2-week treatment period.
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
Secondary
Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for heart rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
beats per minute
Baseline, 2 weeks of treatment over 8 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in a 2-week treatment period
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in a 2-week treatment period.
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
OG003
Placebo
Participants received placebo in a 2-week treatment period.
Secondary
Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF is the QT interval corrected for heart rate using Fridericia formula. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
Posted
Least Squares Mean
Standard Error
milliseconds
Baseline, 2 weeks of treatment over 8 weeks
ID
Title
Description
OG000
LY2624803 1 mg
Participants received LY2624803 1 mg in a 2-week treatment period.
OG001
LY2624803 3 mg
Participants received LY2624803 3 mg in a 2-week treatment period.
OG002
Zolpidem 5 or 10 mg
Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
OG003
Placebo
Time Frame
Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.
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
Period B - LY2624803 1 mg
Patients received LY2624803 1 mg in Period B (2-week treatment period.
1
114
28
114
EG001
Period B - LY2624803 3 mg
Patients received LY2624803 3 mg in Period B (2-week treatment period).
1
113
18
113
EG002
Period B - Placebo
Patients received placebo in Period B (2-week treatment period).
0
117
21
117
EG003
Period B - Zolpidem 5 or 10 mg
Patients received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1
117
33
117
EG004
Period C - LY2624803 1 mg
Patients received LY2624803 1 mg in Period C (2-week treatment period.
0
103
26
103
EG005
Period C - LY2624803 3 mg
Patients received LY2624803 3 mg in Period C (2-week treatment period).
0
97
34
97
EG006
Period C - Placebo
Patients received placebo in Period C (2-week treatment period).
2
98
22
98
EG007
Period C - Zolpidem 5 or 10 mg
Patients received Zolpidem 5 or 10 mg in Period C (2-week treatment period).
1
97
42
97
EG008
Period D - LY2624803 1 mg
Patients received LY2624803 1 mg in Period D (2-week treatment period.
0
91
29
91
EG009
Period D - LY2624803 3 mg
Patients received LY2624803 3 mg in Period D (2-week treatment period).
0
89
35
89
EG010
Period D - Placebo
Patients received placebo in Period D (2-week treatment period).
0
88
25
88
EG011
Period D - Zolpidem 5 or 10 mg
Patients received Zolpidem 5 or 10 mg in Period D (2-week treatment period).
0
94
34
94
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG0031 events1 affected117 at risk
EG0040 events0 affected103 at risk
EG0050 events0 affected97 at risk
EG0060 events0 affected98 at risk
EG0070 events0 affected97 at risk
EG0080 events0 affected91 at risk
EG0090 events0 affected89 at risk
EG0100 events0 affected88 at risk
EG0110 events0 affected94 at risk
Diverticulum
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Extradural haematoma
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG0030 events0 affected117 at risk
EG0040 events0 affected103 at risk
EG0051 events1 affected97 at risk
EG0060 events0 affected98 at risk
EG0070 events0 affected97 at risk
EG0080 events0 affected91 at risk
EG0091 events1 affected89 at risk
EG0101 events1 affected88 at risk
EG0110 events0 affected94 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Eye discharge
Eye disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Eye pain
Eye disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0002 events2 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Stomach discomfort
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Fatigue
General disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0011 events1 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Feeling abnormal
General disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Feeling jittery
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Irritability
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Pain
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Sluggishness
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Suprapubic pain
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Allergy to arthropod sting
Immune system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Cellulitis streptococcal
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Influenza
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0022 events2 affected117 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Otitis media
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0011 events1 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Neck injury
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Poisoning
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Blood pressure increased
Investigations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Electrocardiogram t wave abnormal
Investigations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Heart rate increased
Investigations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0012 events2 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Muscle rigidity
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Coordination abnormal
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Dizziness exertional
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Headache
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0006 events4 affected114 at risk
EG0011 events1 affected113 at risk
EG0023 events3 affected117 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0022 events2 affected117 at risk
EG003
Psychomotor hyperactivity
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Sedation
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0022 events2 affected117 at risk
EG003
Sleep paralysis
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0002 events2 affected114 at risk
EG0010 events0 affected113 at risk
EG0022 events2 affected117 at risk
EG003
Syncope vasovagal
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Tension headache
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0002 events2 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Depression
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Hypervigilance
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Initial insomnia
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Sleep inertia
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Bladder spasm
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Uterine spasm
Reproductive system and breast disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0002 events2 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Postnasal drip
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected114 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected117 at risk
EG003
Postmenopause
Social circumstances
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0021 events1 affected117 at risk
EG003
Hypertension
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected114 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected117 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
D007319
Sleep Initiation and Maintenance Disorders
Ancestor Terms
ID
Term
D020919
Sleep Disorders, Intrinsic
D020920
Dyssomnias
D012893
Sleep Wake Disorders
D009422
Nervous System Diseases
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077334
Zolpidem
Ancestor Terms
ID
Term
D011725
Pyridines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
Adverse Event
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0031 subjects
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Withdrawal by Subject
FG0004 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Sponsor Decision
FG0009 subjects
FG0016 subjects
FG00212 subjects
FG00312 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
2 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
Sponsor Decision
FG0005 subjects
FG0015 subjects
FG0024 subjects
FG0032 subjects
0 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Sponsor Decision
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
52.86
± 13.66
BG00452.27± 14.35
61
BG00361
BG004240
Male
BG00036
BG00150
BG00241
BG00340
BG004167
85
BG00372
BG004306
African
Title
Measurements
BG00021
BG00121
BG00212
BG00318
BG00472
Hispanic
Title
Measurements
BG0006
BG0015
BG0023
BG0039
BG00423
East Asian
Title
Measurements
BG0000
BG0012
BG0021
BG0032
BG0045
Unknown or Not Reported
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
102
BG003101
BG004407
101
22.79
± 5.153
OG003
Placebo
Participants received placebo in Period B (2-week treatment period).
Units
Counts
Participants
OG000102
OG001102
OG002102
OG003101
Title
Denominators
Categories
Before Sleep (n= 101, 101, 101, 101)
Title
Measurements
OG000-7.08± 2.524
OG001-6.45± 2.444
OG002-20.48± 2.440
OG003-1.46± 2.420
During Sleep (n= 101, 102, 101, 101)
Title
Measurements
OG000-14.84± 2.881
OG001-12.95± 2.812
OG002-21.46± 2.819
OG003
After Sleep (n= 100, 101, 99, 99)
Title
Measurements
OG000-9.07± 2.150
OG001-8.31± 2.108
OG002-4.91± 2.119
OG003
Participants received placebo in Period B (2-week treatment period).
Units
Counts
Participants
OG000102
OG001102
OG002102
OG003101
Title
Denominators
Categories
Title
Measurements
OG000-0.27± 0.066
OG001-0.26± 0.065
OG002-0.59± 0.065
OG003-0.18± 0.065
Participants received placebo in Period B (2-week treatment period).
Units
Counts
Participants
OG000102
OG001102
OG002102
OG003101
Title
Denominators
Categories
Title
Measurements
OG000-28.63± 4.678
OG001-28.62± 4.591
OG002-47.28± 4.579
OG003-13.09± 4.547
Participants received placebo in Period B (2-week treatment period).
Units
Counts
Participants
OG000102
OG001102
OG002102
OG003101
Title
Denominators
Categories
Title
Measurements
OG0000.06± 0.009
OG0010.06± 0.009
OG0020.10± 0.009
OG0030.03± 0.009
OG003
Placebo
Participants received placebo in Period B (2-week treatment period).
Units
Counts
Participants
OG000102
OG001102
OG002102
OG003101
Title
Denominators
Categories
Total Score
Title
Measurements
OG0000.17± 0.035
OG0010.17± 0.034
OG0020.25± 0.034
OG0030.13± 0.034
Feeling upon Awakening Subscale
Title
Measurements
OG0000.14± 0.034
OG0010.13± 0.033
OG0020.19± 0.033
OG003
Sleep Experience Subscale
Title
Measurements
OG0000.22± 0.042
OG0010.24± 0.042
OG0020.35± 0.042
OG003
OG003
Placebo
Participants received placebo in Period B (2-week treatment period).
Units
Counts
Participants
OG000100
OG00199
OG00296
OG00397
Title
Denominators
Categories
Title
Measurements
OG000-1.23± 0.395
OG001-0.87± 0.385
OG002-1.20± 0.394
OG003-0.73± 0.386
OG003
Placebo
Participants received placebo in Period B (2-week treatment period).
Units
Counts
Participants
OG00099
OG00196
OG00295
OG00394
Title
Denominators
Categories
Title
Measurements
OG000-2.85± 0.587
OG001-2.83± 0.578
OG002-4.63± 0.582
OG003-1.95± 0.574
OG003
Placebo
Participants received placebo in Period B (2-week treatment period).
Units
Counts
Participants
OG00097
OG00195
OG00294
OG00392
Title
Denominators
Categories
Physical Component Scores
Title
Measurements
OG000-2.32± 1.001
OG001-0.28± 0.987
OG002-0.82± 0.992
OG003-1.84± 0.991
Mental Component Scores
Title
Measurements
OG0002.49± 1.198
OG0011.11± 1.181
OG0021.21± 1.191
OG003
OG003
Placebo
Participants received placebo in Period B (2-week treatment period).
Units
Counts
Participants
OG00098
OG00195
OG00294
OG00393
Title
Denominators
Categories
Title
Measurements
OG000-3.06± 1.525
OG001-2.56± 1.503
OG002-1.71± 1.510
OG0030.23± 1.503
Units
Counts
Participants
OG00099
OG00196
OG00295
OG00394
Title
Denominators
Categories
Period A Treatment (placebo)
Title
Measurements
OG00023.2
OG00122.9
OG00212.6
OG00335.1
Period B Treatment
Title
Measurements
OG00076.8
OG00177.1
OG00287.4
OG003
Units
Counts
Participants
OG000102
OG001102
OG002102
OG00399
Title
Denominators
Categories
1 - Very much improved
Title
Measurements
OG0008.8
OG0019.8
OG00215.7
OG0035.1
2 - Much improved
Title
Measurements
OG00020.6
OG00123.5
OG00234.3
OG003
3 - Minimally improved
Title
Measurements
OG00045.1
OG00137.3
OG00230.4
OG003
4 - No change
Title
Measurements
OG00021.6
OG00128.4
OG00216.7
OG003
5 - Minimally Worse
Title
Measurements
OG0002.0
OG0010
OG0021.0
OG003
6 - Much worse
Title
Measurements
OG0002.0
OG0011.0
OG0022.0
OG003
7 - Very much worse
Title
Measurements
OG0000
OG0010
OG0020
OG003
Units
Counts
Participants
OG00099
OG00196
OG00295
OG00394
Title
Denominators
Categories
1 - Very much improved
Title
Measurements
OG0000
OG0012.1
OG0024.2
OG0033.2
2 - Much improved
Title
Measurements
OG00011.1
OG00116.7
OG00220.0
OG003
3 - Minimally improved
Title
Measurements
OG00062.6
OG00145.8
OG00255.8
OG003
4 - No change
Title
Measurements
OG00024.2
OG00131.3
OG00215.8
OG003
5 - Minimally worse
Title
Measurements
OG0001.0
OG0012.1
OG0024.2
OG003
6 - Much worse
Title
Measurements
OG0000
OG0011.0
OG0020
OG003
7 - Very much worse
Title
Measurements
OG0001.0
OG0011.0
OG0020
OG003
Participants received placebo in Period B (2-week treatment period).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
Participants received placebo in Period B (2-week treatment period).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
Units
Counts
Participants
OG000114
OG001113
OG002117
OG003117
Title
Denominators
Categories
Period B (n= 114, 113, 117, 117)
Title
Measurements
OG00028
OG00118
OG00233
OG00321
Period C (n= 103, 97, 97, 98)
Title
Measurements
OG00026
OG00134
OG00242
OG003
Period D (n= 91, 89, 94, 88)
Title
Measurements
OG00029
OG00135
OG00234
OG003
Units
Counts
Participants
OG000114
OG001113
OG002117
OG003117
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0022
OG0032
Units
Counts
Participants
OG000114
OG001113
OG002117
OG003117
Title
Denominators
Categories
Period B: DBP (n= 112, 111, 117, 117)
Title
Measurements
OG0000.15± 0.607
OG0010.21± 0.610
OG002-0.45± 0.594
OG003-0.41± 0.594
Period B: SBP (n= 112, 111, 117, 117)
Title
Measurements
OG0000.83± 0.908
OG0010.91± 0.912
OG002-0.05± 0.888
OG003
Period C: DBP (n= 102, 97, 97, 97)
Title
Measurements
OG0000.35± 0.675
OG0011.11± 0.693
OG002-0.68± 0.693
OG003
Period C: SBP (n= 102, 97, 97, 97)
Title
Measurements
OG0002.31± 0.932
OG0011.54± 0.960
OG0020.68± 0.957
OG003
Period D: DBP (n= 91, 89, 93, 88)
Title
Measurements
OG0000.33± 0.751
OG001-0.31± 0.760
OG0020.37± 0.743
OG003
Period D: SBP (n= 91, 89, 93, 88)
Title
Measurements
OG0000.03± 1.097
OG0011.17± 1.109
OG0020.87± 1.085
OG003
Units
Counts
Participants
OG000114
OG001113
OG002117
OG003117
Title
Denominators
Categories
Period B (n= 112, 111, 117, 117)
Title
Measurements
OG0000.65± 0.664
OG0010.95± 0.669
OG0020.41± 0.653
OG0030.62± 0.649
Period C (n= 102, 97, 97, 97)
Title
Measurements
OG0000.42± 0.758
OG0010.94± 0.777
OG002-0.64± 0.777
OG003
Period D (n= 91, 89, 93, 88)
Title
Measurements
OG0000.48± 0.813
OG001-0.36± 0.820
OG0021.49± 0.803
OG003
Units
Counts
Participants
OG000114
OG001113
OG002117
OG003117
Title
Denominators
Categories
Period B (n= 111, 111, 115, 114)
Title
Measurements
OG0000.13± 0.105
OG0010.27± 0.105
OG002-0.08± 0.103
OG0030.06± 0.104
Period C (n= 104, 100, 97, 96)
Title
Measurements
OG0000.03± 0.129
OG0010.30± 0.132
OG002-0.07± 0.135
OG003
Period D (n=91, 90, 93, 88)
Title
Measurements
OG0000.12± 0.164
OG0010.17± 0.165
OG0020.08± 0.162
OG003
OG003
Placebo
Participants received placebo in a 2-week treatment period.
Units
Counts
Participants
OG000114
OG001113
OG002117
OG003117
Title
Denominators
Categories
Period B: Alkaline Phosphatase
Title
Measurements
OG0000
OG0011
OG0020
OG0030
Period B: Alanine Transaminase
Title
Measurements
OG0001
OG0010
OG0021
OG003
Period B: Aspartate Transaminase
Title
Measurements
OG0001
OG0011
OG0020
OG003
Period B: Total Bilirubin
Title
Measurements
OG0001
OG0012
OG0020
OG003
Period B: Creatine Phosphokinase
Title
Measurements
OG0001
OG0013
OG0022
OG003
Period B: Creatinine
Title
Measurements
OG0003
OG0011
OG0024
OG003
Period B: Glucose, Non-fasting or random
Title
Measurements
OG0006
OG0014
OG0022
OG003
Period B: Blood Urea Nitrogen
Title
Measurements
OG0002
OG0011
OG0022
OG003
Period B: Hemoglobin
Title
Measurements
OG0002
OG0011
OG0020
OG003
Period B: Leukocyte Count
Title
Measurements
OG0002
OG0011
OG0022
OG003
Period B: Platelet Count
Title
Measurements
OG0001
OG0011
OG0021
OG003
Period C: Alkaline Phosphatase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Period C: Alanine Transaminase
Title
Measurements
OG0000
OG0010
OG0022
OG003
Period C: Aspartate Transaminase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Period C: Total Bilirubin
Title
Measurements
OG0001
OG0011
OG0022
OG003
Period C: Creatine Phosphokinase
Title
Measurements
OG0003
OG0012
OG0020
OG003
Period C: Creatinine
Title
Measurements
OG0003
OG0010
OG0024
OG003
Period C: Glucose, Non-fasting or random
Title
Measurements
OG0004
OG0015
OG0021
OG003
Period C: Blood Urea Nitrogen
Title
Measurements
OG0002
OG0012
OG0021
OG003
Period C: Hemoglobin
Title
Measurements
OG0001
OG0010
OG0022
OG003
Period C: Leukocyte Count
Title
Measurements
OG0002
OG0013
OG0020
OG003
Period C: Platelet Count
Title
Measurements
OG0001
OG0010
OG0021
OG003
Period D: Alkaline Phosphatase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Period D: Alanine Transaminase
Title
Measurements
OG0000
OG0011
OG0021
OG003
Period D: Aspartate Transaminase
Title
Measurements
OG0002
OG0011
OG0021
OG003
Period D: Total Bilirubin
Title
Measurements
OG0003
OG0011
OG0021
OG003
Period D: Creatine Phosphokinase
Title
Measurements
OG0002
OG0012
OG0025
OG003
Period D: Creatinine
Title
Measurements
OG0001
OG0014
OG0024
OG003
Period D: Glucose, Non-fasting or random
Title
Measurements
OG0006
OG0012
OG0024
OG003
Period D: Blood Urea Nitrogen
Title
Measurements
OG0000
OG0012
OG0020
OG003
Period D: Hemoglobin
Title
Measurements
OG0000
OG0011
OG0020
OG003
Period D: Leukocyte Count
Title
Measurements
OG0001
OG0012
OG0023
OG003
Period D: Platelet Count
Title
Measurements
OG0000
OG0013
OG0020
OG003
Units
Counts
Participants
OG000114
OG001113
OG002117
OG003117
Title
Denominators
Categories
Period B (n= 112, 110, 115, 112)
Title
Measurements
OG0001.09± 0.689
OG0010.26± 0.695
OG0021.10± 0.681
OG0030.30± 0.688
Period C (n= 99, 94, 96, 95)
Title
Measurements
OG000-0.59± 0.734
OG0010.31± 0.753
OG002-0.02± 0.745
OG003
Period D (n= 91,86, 93, 87)
Title
Measurements
OG0001.71± 0.827
OG0011.71± 0.851
OG0021.43± 0.818
OG003
Participants received placebo in a 2-week treatment period.