A Study in Painful Diabetic Neuropathy | NCT01089556 | Trialant
NCT01089556
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jan 24, 2013Estimated
Enrollment
811Actual
Phase
Phase 3
Conditions
Diabetic Neuropathy, Painful
Interventions
Duloxetine
Pregabalin
Placebo
Countries
Australia
Canada
Croatia
France
Germany
Greece
Italy
Mexico
Netherlands
Poland
South Korea
Spain
Sweden
Switzerland
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01089556
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
13084
Secondary IDs
ID
Type
Description
Link
F1J-EW-HMGQ
Other Identifier
Eli Lilly and Company
Brief Title
A Study in Painful Diabetic Neuropathy
Official Title
Use of Duloxetine or Pregabalin in Monotherapy Versus Combination Therapy of Both Drugs in Patients With Painful Diabetic Neuropathy "The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study"
Acronym
COMBO-DN
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jan 2013
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
Mar 2010
Primary Completion Date
Nov 2011Actual
Completion Date
Nov 2011Actual
First Submitted Date
Mar 15, 2010
First Submission Date that Met QC Criteria
Mar 17, 2010
First Posted Date
Mar 18, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 30, 2012
Results First Submitted that Met QC Criteria
Oct 30, 2012
Results First Posted Date
Dec 4, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 17, 2013
Last Update Posted Date
Jan 24, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Name
Class
Boehringer Ingelheim
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin.
Detailed Description
Not provided
Conditions Module
Conditions
Diabetic Neuropathy, Painful
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
811Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Duloxetine
Experimental
Initial Treatment:
Duloxetine 30 milligram (mg) daily for 1 week
Duloxetine 60 mg daily for 7 weeks
Intensive Treatment:
Duloxetine 90 mg (60 mg in the morning, 30 mg in the evening) daily for 1 week
Change From Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
Week 8, Week 16
Secondary Outcomes
Measure
Description
Time Frame
Mean Change From Week 8 to Week 16 Endpoint in Items of the Brief Pain Inventory (BPI) Modified Short Form Worst Pain Score
BPI Modified Short Form worst pain score is a self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
Other Outcomes
Measure
Description
Time Frame
Mean Change From Baseline to Week 8 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Pain due to bilateral peripheral neuropathy (caused by type 1 or type 2 diabetes mellitus. Pain must begin in the feet, with relatively symmetrical onset. Daily pain should be present for more than 3 months [assessed by questioning patient]).
Score of at least 4 on the 24-hour average pain severity score on an 11-point Likert scale [on Brief Pain Inventory (BPI) Modified Short Form] at screening and at randomization.
Patient is currently not receiving treatment for diabetic peripheral neuropathic pain (DPNP) or was receiving treatment for DPNP, with a drug other than pregabalin or duloxetine, and completed the required washout
Patient has never received treatment with duloxetine or pregabalin. (However, a short course of less than 15 days of treatment, at any time previously, will be allowed.)
Stable glycemic control, as assessed by a physician investigator, and hemoglobin A1c (HbA1c) less than or equal to 12% at screening.
Exclusion Criteria:
Have a known hypersensitivity to duloxetine or pregabalin or any of the inactive ingredients or have any contraindication for the use of duloxetine or pregabalin.
Have uncontrolled narrow-angle glaucoma.
Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to randomization, or have a potential need to use a MAOI during the study or within 5 days after discontinuation of study drug.
Have received fluoxetine within 30 days prior to randomization.
Have acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
Have a serum creatinine greater than or equal to 1.5 milligram per deciliter (mg/dL) or a creatinine clearance less than 60 milliliter per minute (mL/min), at screening.
Are judged clinically by the investigator to be at suicidal risk or as defined by a score of 2 or greater on Question 9 of the Beck Depression Inventory-II (BDI-II), at screening or randomization
Have a historical exposure to drugs known to cause neuropathy (for example, vincristine), or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have been responsible for neuropathy.
Have pain that cannot be clearly differentiated from or conditions that interfere with the assessment of the DPNP.
Have serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness; symptomatic peripheral vascular disease; a history of seizure disorder; or other medical (including unstable hypertension and not clinically euthyroid) or psychological conditions that, in the opinion of the investigator, would compromise participation or be likely to require hospitalization during the course of the study.
Have received non-pharmacological treatment for pain within 14 days prior to randomization, or do not agree to abstain from non-pharmacological treatment during the study.
Have a history of frequent and/or severe allergic reactions with multiple medications.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
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 - 5AM 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.
Newcastle
New South Wales
2292
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
The study consisted of 4 study periods (SP): 2 weeks screening and washout (SP I), 8 weeks initial treatment (SP II), 8 weeks intensive treatment (SP III), 2 weeks tapering (SP IV). Participants who did not achieve good pain control during SP II (<30% improvement) were considered non-responders and continued in the study and entered SP III.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Duloxetine (SP II)
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II (SP II).
FG001
Pregabalin (SP II)
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks
Duloxetine
Duloxetine + Pregabalin
Pregabalin
Pregabalin+Duloxetine
Week 8, Week 16
Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Week 8 through Week 16
Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Week 8 through Week 16
Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Week 8 through Week 16
Clinical Global Impression of Improvement (CGI-I) at Week 16 Endpoint
Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment for Study Period III. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
Week 16
Mean Change From Week 8 to Week 16 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire
The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
Week 8, Week 16
Mean Change From Week 8 to Week 16 Endpoint in Sheehan Disability Scale (SDS)
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.
Week 8, Week 16
Mean Change From Week 8 to Week 16 Endpoint in Hospital Anxiety and Depression Scale (HADS)
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
Week 8, Week 16
Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Week 8 Through Week 16
Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.
Week 8 through Week 16
Patient Global Impression of Improvement (PGI-I) Score at Week 16 Endpoint
Measures participant's perception of improvement at the time of assessment compared with the start of treatment for Study Period III. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
Week 16
Mean Change in Blood Pressure (BP) From Week 8 to Week 16 Endpoint
Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.
Week 8, Week 16
Mean Change in Heart Rate From Week 8 to Week 16 Endpoint
Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.
Week 8, Week 16
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Between Week 8 and Week 16 Endpoint
TEAEs in Study Period III are events that began or worsened after Week 8 compared with the period before Week 8.
Week 8 through Week 16
Number of Participants Who Discontinued From Study Between Week 8 and Week 16 Endpoint
Week 8 through Week 16
Baseline, Week 8
Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Baseline through Week 8
Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Baseline through Week 8
Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Baseline through Week 8
Clinical Global Impression of Improvement (CGI-I) at Week 8 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 better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit.
Week 8
Mean Change From Baseline to Week 8 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire
The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.
Baseline, Week 8
Mean Change From Baseline to Week 8 Endpoint in Sheehan Disability Scale (SDS)
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) mean values are controlled for treatment, site, baseline value and treatment*site.
Baseline, Week 8
Mean Change From Baseline to Week 8 Endpoint in Hospital Anxiety and Depression Scale (HADS)
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.
Baseline, Week 8
Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Baseline Through Week 8
Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.
Baseline through Week 8
Average Number of Hours Worked for Pay Per Week Baseline Through Week 8
Data presented are the average number of hours worked for pay per week during the last 8 weeks.
Baseline through Week 8
Average Number of Hours Worked for Pay Per Week Week 8 Through Week 16
Data presented are the average number of hours worked for pay per week during the last 8 weeks.
Week 8 through Week 16
Patient Global Impression of Improvement (PGI-I) Score at Week 8 Endpoint
Measures participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit.
Week 8
Mean Change in Blood Pressure (BP) From Baseline to Week 8 Endpoint
Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site.
Baseline, Week 8
Mean Change in Heart Rate From Baseline to Week 8 Endpoint
Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site.
Baseline, Week 8
Number of Participants With Treatment Emergent Adverse Events (TEAE) Between Baseline and Week 8 Endpoint
TEAEs in Study Period II are events that began or worsened after Week 0 compared with the period before Week 0.
Baseline through Week 8
Number of Participants Who Discontinued From Study Between Baseline and Week 8 Endpoint
Baseline through Week 8
Australia
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Warrawong
New South Wales
2502
Australia
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Elizabeth Vale
South Australia
5112
Australia
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Kelowna
British Columbia
V1Y 1Z9
Canada
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Vancouver
British Columbia
V6H 3X8
Canada
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Winnipeg
Manitoba
R3P 3P4
Canada
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Halifax
Nova Scotia
B3H 3A7
Canada
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Cambridge
Ontario
N1R 7L6
Canada
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Laval
Quebec
H7T 2P5
Canada
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Osijek
31000
Croatia
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Rijeka
HR-51000
Croatia
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Varaždin
42000
Croatia
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Zagreb
10000
Croatia
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Angers
49933
France
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Bourges
18000
France
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Juan-les-Pins
06600
France
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Nevers
58000
France
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Nîmes
30029
France
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Paris
75018
France
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Valenciennes
59322
France
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Vierzon
18100
France
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Dresden
01307
Germany
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Schkeuditz
04435
Germany
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Ampelokipoi
11527
Greece
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Athens
11521
Greece
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MelÃssia
15126
Greece
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Catania
95100
Italy
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Milan
20162
Italy
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Naples
80131
Italy
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Rome
00161
Italy
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Mexico City
38000
Mexico
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Eindhoven
5623 EJ
Netherlands
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Maastricht
6229 HX
Netherlands
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Bialystok
15-445
Poland
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Lublin
20-538
Poland
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Szczecin
70-506
Poland
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Wroclaw
50-127
Poland
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Seoul
138-736
South Korea
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Girona
17007
Spain
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Valencia
46010
Spain
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Falköping
SE 52143
Sweden
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Huddinge
SE 141 86
Sweden
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Lund
22185
Sweden
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Stockholm
11522
Sweden
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Zurich
CH-8091
Switzerland
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Ankara
06100
Turkey (Türkiye)
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Izmir
35340
Turkey (Türkiye)
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Ashton-under-Lyne
Ashton-Under-Lyne
OL6 9RW
United Kingdom
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Chorley
Chorley
PR7 1PP
United Kingdom
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Manchester
Greater Manchester
M13 0JE
United Kingdom
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Ayrshire
Scotland
KA6 6DX
United Kingdom
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Nuneaton
Warwickshire
CV10 7BL
United Kingdom
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Livingston
West Lothian
EH54 6PP
United Kingdom
FG002
Duloxetine (SP III)
Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16 in Study Period III (SP III).
FG003
DLX + PGB (SP III)
Duloxetine (DLX) 60 mg plus Pregabalin (PGB) 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16 in Study Period III.
FG004
PGB + DLX (SP III)
Pregabalin (PGB) 300 mg plus Duloxetine (DLX) 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16 in Study Period III.
FG005
Pregabalin (SP III)
Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16 in Study Period III.
FG000404 subjects
FG001407 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Safety Population
FG000401 subjectsReceived at least 1 dose of study drug.
FG001403 subjectsReceived at least 1 dose of study drug.
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Non-responders Who Completed SPII
FG000158 subjects
FG001205 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG000333 subjects
FG001333 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG00071 subjects
FG00174 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Adverse Event
FG00035 subjects
FG00139 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Entry Criteria Not Met
FG00012 subjects
FG0018 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0004 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0004 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00012 subjects
FG00114 subjects
FG0020 subjects
FG0030 subjects
FG004
Not received any study drug
FG0003 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Period III (Weeks 9-16)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00274 subjectsOf those who completed SPII, 10 non-responders did not enter SPIII, while 4 responders entered SPIII
FG00375 subjectsOf those who completed SPII, 6 non-responders did not enter SPIII, while 3 responders entered SPIII
FG00495 subjectsOf those who completed SPII, 10 non-responders did not enter SPIII, while 4 responders entered SPIII
FG00599 subjectsOf those who completed SPII, 6 non-responders did not enter SPIII, while 1 responders entered SPIII
Efficacy and Safety Population
FG0000 subjects
FG0010 subjects
FG00273 subjectsReceived ≥1 dose study drug, had Week 8 and at least 1 assessment during Weeks 9-16 (SPIII)
FG003
COMPLETED
FG0000 subjects
FG0010 subjects
FG00260 subjects
FG00366 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00214 subjects
FG0039 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
BG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000401
BG001403
BG002804
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
BG00061.5± 10.62
BG00161.9± 10.95
BG00261.7± 10.78
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000182
BG001174
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG00037
BG00136
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Greece
Title
Measurements
BG00016
BG00112
BG002
Clinical Global Impressions of Severity Scale (CGI-S)
The clinician recorded how ill the participant was at the time of assessment, in relation to the clinician's total experience with this participant population. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). One participant in Duloxetine group and 2 participants in Pregabalin group had missing data and were not included in the calculation of mean and standard deviation (SD).
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG0004.0± 1.07
BG001
Patient Global Impressions of Severity Scale (PGI-S)
Measures participant's perception of severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (extremely ill).
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG0003.4± 1.42
BG001
Brief Pain Inventory (BPI) Severity: Average Pain Score
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Two participants in Pregabalin group had missing data and were not included in the calculation of mean and SD.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG0006.0± 1.55
BG001
Neuropathic Pain Symptom Inventory (NPSI)
The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. Two participants in Duloxetine group and 6 participants in Pregabalin group had missing data and were not included in the calculation of mean and SD.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG00047.3± 19.16
BG001
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Three participants in both Duloxetine group and Pregabalin group had missing data and were not included in the calculation of mean and SD.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG0006.8± 4.31
BG001
Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Two participants in Duloxetine group and 1 participant in Pregabalin group had missing data and were not included in the calculation of mean and SD.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG0005.5± 4.19
BG001
Sheehan Disability Scale (SDS)
The SDS is completed by the participants and is used to assess the effect of their symptoms on work (Item 1), social (Item 2) and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0-30 with higher values indicating greater disruption in the participant's work/social/family life. There were 118 participants in Duloxetine group and 128 participants in Pregabalin group who had missing data and were not included in the calculation of mean and SD.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG00013.3± 7.47
BG001
Average number of hours worked for pay per week
Data presented are average number of hours worked for pay per week during last 8 weeks prior to entering Study Period II. There were 275 participants in Duloxetine group and 281 participants in Pregabalin group who had missing data and were not included in the calculation of mean and SD.
Mean
Standard Deviation
hours
Title
Denominators
Categories
Title
Measurements
BG00039.5± 20.33
BG001
Number of days of work/school missed
Data presented are the number of days of work/school missed due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks prior to entering Study Period II. There were 278 participants in Duloxetine group and 281 participants in Pregabalin group who had missing data and were not included in the calculation of mean and SD.
Mean
Standard Deviation
days
Title
Denominators
Categories
Title
Measurements
BG0002.3± 7.98
BG001
Number of days hospitalized
Data presented are the number of days hospitalized due to DPNP during the last 8 weeks prior to entering Study Period II. There were 21 participants in Duloxetine group and 23 participants in Pregabalin group who had missing data and were not included in the calculation of mean and SD.
Mean
Standard Deviation
days
Title
Denominators
Categories
Title
Measurements
BG0000.0± 0.45
BG001
Blood pressure (BP)
One participant in both Duloxetine group and Pregabalin group had missing data and were not included in the calculation of mean and SD.
Mean
Standard Deviation
millimeter of mercury (mm Hg)
Title
Denominators
Categories
Systolic BP
Title
Measurements
BG000135.0± 16.27
BG001
Pulse rate
Three participants in Duloxetine group and 1 participant in Pregabalin group had missing data and were not included in the calculation of mean and SD.
Mean
Standard Deviation
beats per minute (bpm)
Title
Denominators
Categories
Title
Measurements
BG00076.0± 10.81
BG001
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 Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III).
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Week 8, Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Units
Counts
Participants
OG000169
OG001170
Title
Denominators
Categories
Title
Measurements
OG000-2.353(-2.688 to -2.017)
OG001-2.161(-2.509 to -1.812)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.370
LS Mean Differences (Final Values)
-0.192
95
No
Superiority or Other
Other Pre-specified
Mean Change From Baseline to Week 8 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.
All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II).
Posted
Least Squares Mean
90% Confidence Interval
units on a scale
Baseline, Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Units
Counts
Secondary
Mean Change From Week 8 to Week 16 Endpoint in Items of the Brief Pain Inventory (BPI) Modified Short Form Worst Pain Score
BPI Modified Short Form worst pain score is a self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III).
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Week 8, Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Other Pre-specified
Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.
Posted
Number
percentage of participants
Baseline through Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Units
Counts
Participants
Secondary
Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.
Posted
Number
percentage of participants
Week 8 through Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Other Pre-specified
Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.
Posted
Number
percentage of participants
Baseline through Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Units
Counts
Participants
Secondary
Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.
Posted
Number
percentage of participants
Week 8 through Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Other Pre-specified
Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.
Posted
Number
percentage of participants
Baseline through Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Units
Counts
Participants
Secondary
Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.
Posted
Number
percentage of participants
Week 8 through Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Other Pre-specified
Clinical Global Impression of Improvement (CGI-I) at Week 8 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 better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit.
All randomized participants who received at least one dose of study drug, and had at least one post-baseline CGI-I measurement during Weeks 1-8 (Study Period II).
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Units
Counts
Participants
Secondary
Clinical Global Impression of Improvement (CGI-I) at Week 16 Endpoint
Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment for Study Period III. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
All randomized participants who received at least one dose of study drug, and had at least one CGI-I measurement during Weeks 9-16 (Study Period III).
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Other Pre-specified
Mean Change From Baseline to Week 8 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire
The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.
All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline NPSI measurements during Weeks 1-8 (Study Period II).
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline, Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Units
Secondary
Mean Change From Week 8 to Week 16 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire
The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
All randomized participants who received at least one dose of study drug, and had Week 8 and at least one NPSI measurements during Weeks 9-16 (Study Period III).
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Week 8, Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Other Pre-specified
Mean Change From Baseline to Week 8 Endpoint in Sheehan Disability Scale (SDS)
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) mean values are controlled for treatment, site, baseline value and treatment*site.
All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline SDS measurement during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline, Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Secondary
Mean Change From Week 8 to Week 16 Endpoint in Sheehan Disability Scale (SDS)
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.
All randomized participants who received at least one dose of study drug, and had Week 8 and at least one SDS measurement during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Week 8, Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Other Pre-specified
Mean Change From Baseline to Week 8 Endpoint in Hospital Anxiety and Depression Scale (HADS)
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.
All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline HADS measurements during Weeks 1-8 (Study Period II).
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline, Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Secondary
Mean Change From Week 8 to Week 16 Endpoint in Hospital Anxiety and Depression Scale (HADS)
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
All randomized participants who received at least one dose of study drug, and had Week 8 and at least one HADS measurements during Weeks 9-16 (Study Period III).
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Week 8, Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Other Pre-specified
Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Baseline Through Week 8
Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.
All randomized participants who received at least one dose of study drug and provided information of hospitalization and sick leave during Weeks 1-8 (Study Period II).
Posted
Mean
Standard Deviation
days
Baseline through Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Units
Counts
Participants
OG000
Secondary
Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Week 8 Through Week 16
Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.
All randomized participants who received at least one dose of study drug and provided information of hospitalization and sick leave during Weeks 9-16 (Study Period III).
Posted
Mean
Standard Deviation
days
Week 8 through Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Other Pre-specified
Average Number of Hours Worked for Pay Per Week Baseline Through Week 8
Data presented are the average number of hours worked for pay per week during the last 8 weeks.
All randomized participants who received at least one dose of study drug and had worked for pay during Weeks 1-8 (Study Period II).
Posted
Mean
Standard Deviation
hours
Baseline through Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Units
Counts
Participants
OG000
Other Pre-specified
Average Number of Hours Worked for Pay Per Week Week 8 Through Week 16
Data presented are the average number of hours worked for pay per week during the last 8 weeks.
All randomized participants who received at least one dose of study drug and had worked for pay during Weeks 9-16 (Study Period III).
Posted
Mean
Standard Deviation
hours
Week 8 through Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Units
Counts
Other Pre-specified
Patient Global Impression of Improvement (PGI-I) Score at Week 8 Endpoint
Measures participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit.
All randomized participants who received at least one dose of study drug, and at least one post-baseline PGI-I measurement during Weeks 1-8 (Study Period II).
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Units
Counts
Participants
Secondary
Patient Global Impression of Improvement (PGI-I) Score at Week 16 Endpoint
Measures participant's perception of improvement at the time of assessment compared with the start of treatment for Study Period III. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.
All randomized participants who received at least one dose of study drug, and at least one PGI-I measurement during Weeks 9-16 (Study Period III).
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Other Pre-specified
Mean Change in Blood Pressure (BP) From Baseline to Week 8 Endpoint
Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site.
All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BP measurement during Week 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.
Posted
Least Squares Mean
95% Confidence Interval
millimeter of mercury (mm Hg)
Baseline, Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Units
Counts
Participants
OG000
Secondary
Mean Change in Blood Pressure (BP) From Week 8 to Week 16 Endpoint
Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.
All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BP measurement during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.
Posted
Least Squares Mean
95% Confidence Interval
millimeter of mercury (mm Hg)
Week 8, Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Other Pre-specified
Mean Change in Heart Rate From Baseline to Week 8 Endpoint
Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site.
All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline heart rate measurement during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.
Posted
Least Squares Mean
95% Confidence Interval
beats per minute (bpm)
Baseline, Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Units
Counts
Participants
OG000
Secondary
Mean Change in Heart Rate From Week 8 to Week 16 Endpoint
Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.
All randomized participants who received at least one dose of study drug, and had Week 8 and at least one heart rate measurement during Weeks 9- 16 (Study Period III). Last observation carried forward (LOCF) principle was used.
Posted
Least Squares Mean
95% Confidence Interval
beats per minute (bpm)
Week 8, Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Other Pre-specified
Number of Participants With Treatment Emergent Adverse Events (TEAE) Between Baseline and Week 8 Endpoint
TEAEs in Study Period II are events that began or worsened after Week 0 compared with the period before Week 0.
All randomized participants who received at least one dose of study drug during Weeks 1-8 (Study Period II).
Posted
Number
participants
Baseline through Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Between Week 8 and Week 16 Endpoint
TEAEs in Study Period III are events that began or worsened after Week 8 compared with the period before Week 8.
All randomized participants who received at least one dose of study drug during Weeks 9-16 (Study Period III).
Posted
Number
participants
Week 8 through Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Units
Counts
Other Pre-specified
Number of Participants Who Discontinued From Study Between Baseline and Week 8 Endpoint
All randomized participants who received at least one dose of study drug during Weeks 1-8 (Study Period II).
Posted
Number
participants
Baseline through Week 8
ID
Title
Description
OG000
Duloxetine
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
OG001
Pregabalin
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
Units
Counts
Participants
OG000
Secondary
Number of Participants Who Discontinued From Study Between Week 8 and Week 16 Endpoint
All randomized participants who received at least one dose of study drug during Weeks 9-16 (Study Period III).
Posted
Number
participants
Week 8 through Week 16
ID
Title
Description
OG000
Combination
All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
OG001
Monotherapy
All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
Units
Counts
Participants
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Duloxetine (SP II)
Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II (SP II).
12
401
216
401
EG001
Pregabalin (SP II)
Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
13
403
225
403
EG002
Duloxetine (SP III)
Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16 in Study Period III (SP III).
3
73
18
73
EG003
DLX + PGB (SP III)
Duloxetine (DLX) 60 mg plus Pregabalin (PGB) 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16 in Study Period III.
3
75
21
75
EG004
PGB + DLX (SP III)
Pregabalin (PGB) 300 mg plus Duloxetine (DLX) 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16 in Study Period III.
5
94
39
94
EG005
Pregabalin (SP III)
Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16 in Study Period III.
2
97
37
97
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure
Cardiac disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG0030 events0 affected75 at risk
EG0040 events0 affected94 at risk
EG0051 events1 affected97 at risk
Abdominal pain
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Constipation
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Duodenitis
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Flatulence
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Gastritis
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Nausea
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Vomiting
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Chest pain
General disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0012 events2 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Hernia
General disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Bronchopneumonia
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Cellulitis
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Erysipelas
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Gastroenteritis
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Gastrointestinal infection
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Pilonidal cyst
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Pneumonia
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Viral infection
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Brain contusion
Injury, poisoning and procedural complications
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Fall
Injury, poisoning and procedural complications
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Haemoglobin decreased
Investigations
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Hepatitis c antibody positive
Investigations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Gout
Metabolism and nutrition disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0013 events3 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Large intestine carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Ischaemic stroke
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Myelitis transverse
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Presyncope
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Confusional state
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Disorientation
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Hallucination
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Suicidal ideation
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0012 events2 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Deep vein thrombosis
Vascular disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Hypertension
Vascular disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Hypertensive crisis
Vascular disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0012 events2 affected403 at risk
EG0020 events0 affected73 at risk
EG0031 events1 affected75 at risk
EG0040 events0 affected94 at risk
EG0050 events0 affected97 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Angina pectoris
Cardiac disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Palpitations
Cardiac disorders
MEDDRA (13.1)
Systematic Assessment
EG0004 events4 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Tachycardia
Cardiac disorders
MEDDRA (13.1)
Systematic Assessment
EG0004 events4 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Hearing impaired
Ear and labyrinth disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Vertigo
Ear and labyrinth disorders
MEDDRA (13.1)
Systematic Assessment
EG0008 events8 affected401 at risk
EG00127 events26 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Hyperthyroidism
Endocrine disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Eyelid oedema
Eye disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Vision blurred
Eye disorders
MEDDRA (13.1)
Systematic Assessment
EG0006 events5 affected401 at risk
EG0013 events3 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Visual impairment
Eye disorders
MEDDRA (13.1)
Systematic Assessment
EG0002 events2 affected401 at risk
EG0011 events1 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0002 events2 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0005 events5 affected401 at risk
EG0013 events3 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Chapped lips
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Constipation
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG00017 events16 affected401 at risk
EG00114 events13 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG00014 events14 affected401 at risk
EG00112 events11 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Dry mouth
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG00017 events16 affected401 at risk
EG00111 events9 affected403 at risk
EG0022 events2 affected73 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0004 events4 affected401 at risk
EG0014 events4 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Flatulence
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0004 events4 affected401 at risk
EG0015 events5 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Gastritis
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0005 events5 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0002 events2 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Nausea
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG00061 events57 affected401 at risk
EG00126 events25 affected403 at risk
EG0022 events2 affected73 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Toothache
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Vomiting
Gastrointestinal disorders
MEDDRA (13.1)
Systematic Assessment
EG00013 events12 affected401 at risk
EG0017 events6 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Asthenia
General disorders
MEDDRA (13.1)
Systematic Assessment
EG0008 events6 affected401 at risk
EG0017 events7 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Chest discomfort
General disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Chest pain
General disorders
MEDDRA (13.1)
Systematic Assessment
EG0002 events2 affected401 at risk
EG0013 events3 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Discomfort
General disorders
MEDDRA (13.1)
Systematic Assessment
EG0002 events2 affected401 at risk
EG0011 events1 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Facial pain
General disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Fatigue
General disorders
MEDDRA (13.1)
Systematic Assessment
EG00018 events18 affected401 at risk
EG00113 events13 affected403 at risk
EG0022 events2 affected73 at risk
EG003
Gait disturbance
General disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0014 events4 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Oedema
General disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0017 events7 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Oedema peripheral
General disorders
MEDDRA (13.1)
Systematic Assessment
EG0005 events4 affected401 at risk
EG00123 events21 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Pain
General disorders
MEDDRA (13.1)
Systematic Assessment
EG0002 events2 affected401 at risk
EG0012 events2 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Therapeutic response unexpected
General disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Bronchitis
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0013 events3 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Cystitis
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Erysipelas
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Gastroenteritis
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Gastroenteritis viral
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Infection
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Influenza
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Nasopharyngitis
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0003 events3 affected401 at risk
EG0015 events5 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Onychomycosis
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Pharyngitis
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0012 events2 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Pneumonia
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Tooth abscess
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0012 events2 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Urinary tract infection
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0012 events2 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Vaginal infection
Infections and infestations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0013 events3 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Fall
Injury, poisoning and procedural complications
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0012 events2 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Subcutaneous haematoma
Injury, poisoning and procedural complications
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Hepatic enzyme increased
Investigations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Visual acuity tests abnormal
Investigations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Vitamin b12 decreased
Investigations
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Weight increased
Investigations
MEDDRA (13.1)
Systematic Assessment
EG0002 events2 affected401 at risk
EG0019 events9 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MEDDRA (13.1)
Systematic Assessment
EG00018 events17 affected401 at risk
EG0012 events2 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MEDDRA (13.1)
Systematic Assessment
EG0002 events2 affected401 at risk
EG0012 events2 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MEDDRA (13.1)
Systematic Assessment
EG0007 events4 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0016 events6 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0004 events3 affected401 at risk
EG0014 events4 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0003 events3 affected401 at risk
EG0016 events5 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0013 events3 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0005 events4 affected401 at risk
EG0012 events2 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0012 events2 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0003 events3 affected401 at risk
EG0014 events3 affected403 at risk
EG0023 events3 affected73 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Amnesia
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Balance disorder
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0005 events4 affected401 at risk
EG0017 events7 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Disturbance in attention
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0002 events2 affected401 at risk
EG0018 events7 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Dizziness
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG00036 events29 affected401 at risk
EG00169 events61 affected403 at risk
EG0025 events4 affected73 at risk
EG003
Dysaesthesia
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0011 events1 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Dysarthria
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0013 events2 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Dysgeusia
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Headache
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG00021 events19 affected401 at risk
EG00115 events13 affected403 at risk
EG0023 events3 affected73 at risk
EG003
Hypoaesthesia
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Hypotonia
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Lethargy
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0007 events7 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Migraine with aura
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Neuralgia
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0002 events2 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Paraesthesia
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Psychomotor skills impaired
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Sciatica
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Sedation
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0003 events3 affected401 at risk
EG0015 events3 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Sensory loss
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Somnolence
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG00046 events40 affected401 at risk
EG00150 events44 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Syncope
Nervous system disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Anxiety
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0003 events3 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Apathy
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0002 events2 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Delirium
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Depression
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0016 events4 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Dissociation
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Insomnia
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0008 events8 affected401 at risk
EG0014 events4 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Libido decreased
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0002 events2 affected401 at risk
EG0015 events5 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Loss of libido
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Mood swings
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Paranoia
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Restlessness
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Sleep disorder
Psychiatric disorders
MEDDRA (13.1)
Systematic Assessment
EG0006 events6 affected401 at risk
EG0016 events6 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Dysuria
Renal and urinary disorders
MEDDRA (13.1)
Systematic Assessment
EG0009 events9 affected401 at risk
EG0012 events2 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Urine flow decreased
Renal and urinary disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MEDDRA (13.1)
Systematic Assessment
EG0006 events6 affected401 at risk
EG0014 events4 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MEDDRA (13.1)
Systematic Assessment
EG0002 events2 affected401 at risk
EG0012 events2 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0012 events2 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG00016 events16 affected401 at risk
EG0014 events4 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0001 events1 affected401 at risk
EG0010 events0 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0002 events1 affected401 at risk
EG0013 events3 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0003 events3 affected401 at risk
EG0011 events1 affected403 at risk
EG0022 events1 affected73 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Arteriosclerosis
Vascular disorders
MEDDRA (13.1)
Systematic Assessment
EG0003 events3 affected401 at risk
EG0016 events6 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Hypertension
Vascular disorders
MEDDRA (13.1)
Systematic Assessment
EG0007 events7 affected401 at risk
EG0013 events3 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Hypotension
Vascular disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0021 events1 affected73 at risk
EG003
Phlebitis
Vascular disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Thrombophlebitis
Vascular disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0010 events0 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Venous insufficiency
Vascular disorders
MEDDRA (13.1)
Systematic Assessment
EG0000 events0 affected401 at risk
EG0011 events1 affected403 at risk
EG0020 events0 affected73 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
D003929
Diabetic Neuropathies
Ancestor Terms
ID
Term
D010523
Peripheral Nervous System Diseases
D009468
Neuromuscular Diseases
D009422
Nervous System Diseases
D048909
Diabetes Complications
D003920
Diabetes Mellitus
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068736
Duloxetine Hydrochloride
D000069583
Pregabalin
Ancestor Terms
ID
Term
D013876
Thiophenes
D013457
Sulfur Compounds
D009930
Organic Chemicals
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D005680
gamma-Aminobutyric Acid
D000613
Aminobutyrates
D002087
Butyrates
D000144
Acids, Acyclic
D002264
Carboxylic Acids
D000596
Amino Acids
D000602
Amino Acids, Peptides, and Proteins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
75 subjects
Received ≥1 dose study drug, had Week 8 and at least 1 assessment during Weeks 9-16 (SPIII)
FG00494 subjectsReceived ≥1 dose study drug, had Week 8 and at least 1 assessment during Weeks 9-16 (SPIII)
FG00597 subjectsReceived ≥1 dose study drug, had Week 8 and at least 1 assessment during Weeks 9-16 (SPIII)