Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 75 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

A Study of Duloxetine (LY248686) in Participants With Diabetic Peripheral Neuropathic Pain (DPNP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02417935
Recruitment Status : Completed
First Posted : April 16, 2015
Results First Posted : July 10, 2018
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
Shionogi
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetic Peripheral Neuropathic Pain
Interventions Drug: Duloxetine
Drug: Pregabalin
Drug: Placebo
Enrollment 304
Recruitment Details 12 week Treatment period, followed by 1 week Tapering period, followed by 1 week follow-up period.
Pre-assignment Details  
Arm/Group Title Pregabalin Duloxetine
Hide Arm/Group Description

Participants received flexible doses of 150 to 600 mg pregabalin orally twice a day (BID) along with Duloxetine placebo during treatment period.

Participants who received higher doses of Pregabalin in treatment period received gradually the lower doses of Pregabalin along with Duloxetine placebo during tapering period.

Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo during treatment period.

Participants who received higher doses of Duloxetine in treatment period received gradually the lower doses of Duloxetine along with Pregabalin placebo during tapering period.

Period Title: Treatment Period
Started 151 153
Received at Least One Dose of Study Drug 151 152
Completed 130 137
Not Completed 21 16
Reason Not Completed
Adverse Event             12             10
Lost to Follow-up             1             0
Entry Criteria not met             0             1
Protocol Violation             2             1
Withdrawal by Subject             3             3
Physician Decision             3             1
Period Title: Tapering Period
Started 134 [1] 142 [1]
Completed 134 142
Not Completed 0 0
[1]
Participants who discontinued treatment period had an option to enter the taper period
Arm/Group Title Pregabalin Duloxetine Total
Hide Arm/Group Description

Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine placebo during treatment period.

Participants who received higher doses of Pregabalin in treatment period received gradually the lower doses of Pregabalin along with Duloxetine placebo during tapering period.

Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo during treatment period.

Participants who received higher doses of Duloxetine in treatment period received gradually the lower doses of Duloxetine along with Pregabalin placebo during tapering period.

Total of all reporting groups
Overall Number of Baseline Participants 151 152 303
Hide Baseline Analysis Population Description
All randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 151 participants 152 participants 303 participants
60.0  (9.84) 59.3  (8.16) 59.6  (9.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 152 participants 303 participants
Female 42 41 83
Male 109 111 220
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 152 participants 303 participants
American Indian or Alaska Native 0 0 0
Asian 151 152 303
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 0 0 0
White 0 0 0
More than one race 0 0 0
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Japan Number Analyzed 151 participants 152 participants 303 participants
151 152 303
Numeric Rating Scale (NRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 151 participants 152 participants 303 participants
Average Pain Score 5.35  (1.129) 5.38  (1.079) 5.37  (1.102)
Night Pain Score 4.61  (1.855) 4.92  (1.650) 4.76  (1.759)
Worst Pain Score 6.25  (1.311) 6.22  (1.237) 6.23  (1.273)
[1]
Measure Description: 24-hour average pain, night pain & 24-hour worst pain severity scores were recorded on an 11-point NRS, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).Weekly mean was calculated based on daily score and used for the analysis.
Brief Pain Inventory - Short Form (BPI-SF)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 151 participants 152 participants 303 participants
Worst Pain 6.3  (1.45) 6.3  (1.24) 6.3  (1.35)
Least Pain 3.8  (1.74) 3.9  (1.70) 3.9  (1.72)
Average Pain 5.3  (1.21) 5.3  (1.17) 5.3  (1.19)
Pain Right Now 4.9  (1.60) 4.9  (1.58) 4.9  (1.59)
General Activity 3.1  (2.14) 3.4  (2.21) 3.3  (2.18)
Mood 3.3  (2.32) 2.9  (2.23) 3.1  (2.28)
Walking Ability 2.9  (2.28) 2.8  (2.51) 2.8  (2.39)
Normal Work 2.6  (2.11) 2.6  (2.41) 2.6  (2.26)
Relations With Other People 1.4  (1.81) 1.4  (1.81) 1.4  (1.80)
Sleep 2.7  (2.39) 2.8  (2.37) 2.8  (2.38)
Enjoyment of Life 2.6  (2.27) 2.5  (2.24) 2.5  (2.25)
Average Interference Score 2.66  (1.744) 2.63  (1.875) 2.64  (1.807)
[1]
Measure Description: BPI Severity (BPI-S) & BPI Interference Scores (BPI-I) are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (as bad as you can imagine) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Beck Depression Inventory-II (BDI-II)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 151 participants 152 participants 303 participants
6.2  (5.41) 6.8  (5.90) 6.5  (5.66)
[1]
Measure Description: Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.
Neuropathic Pain Symptom Inventory (NPSI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 151 participants 152 participants 303 participants
31.8  (15.60) 32.1  (16.49) 31.9  (16.03)
[1]
Measure Description: NPSI questionnaire is a 12-item self-administered questionnaire that will be completed by the patient. It assesses 5 different dimensions of neuropathic pain: burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesias/dysesthesias. The NPSI includes 12 items: 10 descriptors of the different symptoms and 2 items for assessing the duration of spontaneous ongoing and paroxysmal pain. A total intensity score can be calculated as the sum of the scores of the 10 descriptors. (range: 0 (no pain) -100 (worst imaginable pain)).
EuroQol 5 Dimension (EQ-5D)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 151 participants 152 participants 303 participants
0.7253  (0.0903) 0.7337  (0.1230) 0.7296  (0.1079)
[1]
Measure Description: The EQ-5D is a self-reported, 5-item scale used to assess the patient’s health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale.These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm.Range of the Index score is -0.111 - 1(higher score indicates better health state).
1.Primary Outcome
Title Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale (NRS)
Hide Description

11-point NRS measures the severity of pain over the previous 24 hours. Participants were asked to provide 24-hour average pain scores in the daily Participant diary and among these, the weekly mean of the 24-hour average pain score was calculated. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine).

Mixed Model Repeated Measures (MMRM) model with baseline value, Duration of diabetic peripheral neuropathic pain (DPNP), treatment, week, treatment-by-week interaction as fixed effects was used to produce Least Square Mean (LS Mean).

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for NRS.
Arm/Group Title Pregabalin Duloxetine
Hide Arm/Group Description:
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
Overall Number of Participants Analyzed 149 152
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.358  (0.133) -2.286  (0.133)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments If the upper bound of the 95% CI does not exceed 0.51 (pre-defined non-inferiority margin), it will be concluded that duloxetine is not inferior to Pregabalin.
Statistical Test of Hypothesis P-Value 0.700
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.072
Confidence Interval (2-Sided) 95%
-0.295 to 0.439
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Patient Global Impression of Improvement (PGI-I) at 12 Weeks
Hide Description

PGI-I assessments was completed by the participant. The participant records how he/she perceives the degree of improvement (or worsening) at the time of assessment since taking treatment. The score ranges from 1 (very much better) to 7 (very much worse).

MMRM model with duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS Mean.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had at least one post baseline observation.
Arm/Group Title Pregabalin Duloxetine
Hide Arm/Group Description:
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
Overall Number of Participants Analyzed 149 152
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.6  (0.1) 2.4  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.149
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.4 to 0.1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Hide Description

Brief Pain Inventory Severity and Interference Scores: BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (pain as bad as you can imagine) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.

MMRM model with baseline, duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS mean.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for BPI-SF.
Arm/Group Title Pregabalin Duloxetine
Hide Arm/Group Description:
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
Overall Number of Participants Analyzed 149 152
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Worst Pain Number Analyzed 149 participants 152 participants
-2.8  (0.2) -2.7  (0.2)
Least Pain Number Analyzed 149 participants 152 participants
-1.7  (0.1) -1.9  (0.1)
Average Pain Number Analyzed 149 participants 152 participants
-2.5  (0.1) -2.4  (0.1)
Pain Right Now Number Analyzed 149 participants 152 participants
-2.4  (0.1) -2.4  (0.1)
General Activity Number Analyzed 149 participants 151 participants
-1.9  (0.1) -2.1  (0.1)
Mood Number Analyzed 149 participants 151 participants
-1.9  (0.1) -2.1  (0.1)
Walking Ability Number Analyzed 149 participants 151 participants
-1.8  (0.1) -1.9  (0.1)
Normal Work Number Analyzed 149 participants 151 participants
-1.6  (0.1) -1.8  (0.1)
Relations with Other People Number Analyzed 149 participants 151 participants
-0.7  (0.1) -0.9  (0.1)
Sleep Number Analyzed 149 participants 151 participants
-1.7  (0.1) -1.7  (0.1)
Enjoyment of Life Number Analyzed 149 participants 151 participants
-1.6  (0.1) -1.8  (0.1)
Average Interference Number Analyzed 149 participants 152 participants
-1.60  (0.10) -1.77  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Worst Pain
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .535
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Least Pain
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .436
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.5 to 0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Average Pain
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .534
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.2 to 0.5
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Pain Right Now
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .948
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.4 to 0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments General Activity
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .225
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.6 to 0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Mood
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .276
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.6 to 0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Walking Ability
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .507
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.4 to 0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Normal Work
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .216
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.5 to 0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Relations with other people
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .233
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.4 to 0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Sleep
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .857
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.3 to 0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Enjoyment of life
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .133
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.5 to 0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Average Interference Score
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .246
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.44 to 0.11
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to 12 Weeks on the Neuropathic Pain Symptom Inventory (NPSI)
Hide Description

NPSI questionnaire is a 12-item self-administered questionnaire that will be completed by the participant. It assesses 5 different dimensions of neuropathic pain on a scale of 0 (no symptom) to 10 (worst imaginable symptom): burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesias/dysesthesias. The NPSI includes 12 items: 10 descriptors of the different symptoms and 2 items for assessing the duration of spontaneous ongoing and paroxysmal pain. A total score can be calculated as the sum of the scores of the 10 descriptors with scale range: 0 (no pain) -100 (worst pain imaginable).

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) with baseline, treatment, and duration of DPNP as fixed effects was used to produce LS mean.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug & had baseline & at least one post-baseline observation for NPSI.
Arm/Group Title Pregabalin Duloxetine
Hide Arm/Group Description:
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
Overall Number of Participants Analyzed 148 151
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Total Score -15.4  (1.1) -16.1  (1.1)
Burning Pain -1.1  (0.2) -1.3  (0.2)
Pressing Pain -1.4  (0.1) -1.4  (0.1)
Paroxysmal Pain -1.7  (0.1) -1.7  (0.1)
Evoked Pain -1.0  (0.1) -1.2  (0.1)
Paresthesia/Dysesthesia -2.5  (0.1) -2.6  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Total Score
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .627
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-3.6 to 2.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Burning Pain
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .355
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.6 to 0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Pressing Pain
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .731
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Paroxysmal Pain
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .721
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Evoked Pain
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .345
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.5 to 0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments Paresthesia/Dysesthesia
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .557
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.5 to 0.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Clinical Global Impression of Improvement (CGI-I) at 12 Weeks
Hide Description

CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse).

MMRM model with duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS Mean.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had at least one post baseline observation for CGI-I
Arm/Group Title Pregabalin Duloxetine
Hide Arm/Group Description:
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
Overall Number of Participants Analyzed 149 152
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.6  (0.1) 2.5  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .106
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.4 to 0.0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to 12 Weeks on the EuroQol 5 Dimension (EQ-5D)
Hide Description

The EQ-5D is a self-reported, 5-item scale used to assess the patient's health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale.These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm (range of the Index score is -0.111 - 1).A higher score indicates better health state.

ANCOVA model with LOCF with baseline value, treatment and duration of DPNP as fixed effects was used to produce LS mean.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline observation for EQ-5D.
Arm/Group Title Pregabalin Duloxetine
Hide Arm/Group Description:
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
Overall Number of Participants Analyzed 148 151
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.1004  (0.0112) 0.1144  (0.0112)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .361
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0140
Confidence Interval (2-Sided) 95%
-0.0161 to 0.0441
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to 12 Weeks on the Beck Depression Inventory-II (BDI-II) Total Score
Hide Description

Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.

MMRM model with baseline value, duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS mean.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for BDI-II.
Arm/Group Title Pregabalin Duloxetine
Hide Arm/Group Description:
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
Overall Number of Participants Analyzed 146 141
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.5  (0.3) -2.3  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .701
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.8 to 1.1
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline to 12 Weeks in the Weekly Mean of Night Pain Scores on the 11-Point NRS
Hide Description

Night pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the night pain score was calculated based on the daily pain score.

MMRM model with baseline value, treatment, week, duration of DPNP and treatment-by-week interaction as fixed effects was used to produce LS mean.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for night pain NRS.
Arm/Group Title Pregabalin Duloxetine
Hide Arm/Group Description:
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
Overall Number of Participants Analyzed 149 152
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.166  (0.131) -2.160  (0.131)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .976
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.005
Confidence Interval (2-Sided) 95%
-0.355 to 0.366
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Worst Pain Scores on the 11-Point NRS
Hide Description

24-hour worst pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the worst pain score was calculated based on the daily score.

MMRM model with baseline value, duration of DPNP, treatment, week, treatment-by-week interaction as fixed effects was used to produce LS mean.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for worst pain score NRS.
Arm/Group Title Pregabalin Duloxetine
Hide Arm/Group Description:
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
Overall Number of Participants Analyzed 149 152
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.553  (0.145) -2.416  (0.145)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .503
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.136
Confidence Interval (2-Sided) 95%
-0.264 to 0.537
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants With a 30% and 50% Reduction in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point NRS at 12 Weeks
Hide Description 11-point NRS measures the severity of pain over the previous 24 hours. Patients were asked to provide 24-hour average pain scores in the daily patient diary. scores range from 0 (no pain) to 10 (pain as bad as you can imagine) and among these, the weekly mean of the 24-hour average pain score was calculated based on daily score.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug & had baseline & at least one post-baseline observation for average pain score NRS .
Arm/Group Title Pregabalin Duloxetine
Hide Arm/Group Description:
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
Overall Number of Participants Analyzed 149 152
Measure Type: Count of Participants
Unit of Measure: Participants
30% Reduction
94
  63.1%
100
  65.8%
50% Reduction
62
  41.6%
62
  40.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .632
Comments 30% reduction
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Duloxetine
Comments 50% Reduction
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .907
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Up to 14 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregabalin Duloxetine
Hide Arm/Group Description Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo. Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
All-Cause Mortality
Pregabalin Duloxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/151 (0.00%)      0/152 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin Duloxetine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/151 (3.97%)      1/152 (0.66%)    
Cardiac disorders     
Cardiac failure congestive  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Myocardial infarction  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Gastrointestinal disorders     
Diverticulum intestinal haemorrhagic  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Gastric ulcer  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Pancreatitis acute  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Infections and infestations     
Staphylococcal sepsis  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Injury, poisoning and procedural complications     
Wrist fracture  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Vascular disorders     
Shock  1  0/151 (0.00%)  0 1/152 (0.66%)  1
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregabalin Duloxetine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   91/151 (60.26%)      86/152 (56.58%)    
Blood and lymphatic system disorders     
Anaemia  1  0/151 (0.00%)  0 2/152 (1.32%)  2
Cardiac disorders     
Arrhythmia  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  3/151 (1.99%)  3 2/152 (1.32%)  2
Eye disorders     
Diabetic retinopathy  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Dry eye  1  2/151 (1.32%)  2 0/152 (0.00%)  0
Foreign body sensation in eyes  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Macular oedema  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Open angle glaucoma  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Retinopathy  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Gastrointestinal disorders     
Abdominal discomfort  1  2/151 (1.32%)  2 2/152 (1.32%)  2
Abdominal distension  1  1/151 (0.66%)  1 1/152 (0.66%)  1
Abdominal pain  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Chronic gastritis  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Constipation  1  4/151 (2.65%)  4 6/152 (3.95%)  6
Diabetic gastroenteropathy  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Diarrhoea  1  5/151 (3.31%)  5 2/152 (1.32%)  2
Dry mouth  1  0/151 (0.00%)  0 2/152 (1.32%)  2
Dyspepsia  1  1/151 (0.66%)  1 1/152 (0.66%)  1
Enteritis  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Eructation  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Gastritis  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Gastroduodenal ulcer  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Gastrointestinal disorder  1  2/151 (1.32%)  2 1/152 (0.66%)  1
Gastrooesophageal reflux disease  1  0/151 (0.00%)  0 3/152 (1.97%)  3
Hiatus hernia  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Nausea  1  7/151 (4.64%)  7 12/152 (7.89%)  13
Periodontal disease  1  1/151 (0.66%)  1 1/152 (0.66%)  1
Stomatitis  1  0/151 (0.00%)  0 3/152 (1.97%)  4
Vomiting  1  1/151 (0.66%)  1 6/152 (3.95%)  9
General disorders     
Asthenia  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Chest discomfort  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Chest pain  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Fatigue  1  0/151 (0.00%)  0 2/152 (1.32%)  2
Feeling abnormal  1  4/151 (2.65%)  4 1/152 (0.66%)  1
Gait disturbance  1  2/151 (1.32%)  2 0/152 (0.00%)  0
Malaise  1  1/151 (0.66%)  1 2/152 (1.32%)  2
Nodule  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Oedema  1  2/151 (1.32%)  2 0/152 (0.00%)  0
Oedema peripheral  1  4/151 (2.65%)  4 0/152 (0.00%)  0
Pain  1  2/151 (1.32%)  2 0/152 (0.00%)  0
Thirst  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Xerosis  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Hepatobiliary disorders     
Hepatic function abnormal  1  0/151 (0.00%)  0 2/152 (1.32%)  2
Hepatic steatosis  1  1/151 (0.66%)  1 1/152 (0.66%)  1
Infections and infestations     
Bronchitis  1  2/151 (1.32%)  2 2/152 (1.32%)  2
Chronic sinusitis  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Conjunctivitis  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Cystitis  1  2/151 (1.32%)  3 0/152 (0.00%)  0
Enteritis infectious  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Gastroenteritis  1  0/151 (0.00%)  0 3/152 (1.97%)  3
Herpes zoster  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Myringitis  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Otitis media  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Periodontitis  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Pharyngitis  1  2/151 (1.32%)  2 2/152 (1.32%)  5
Pyoderma  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Skin bacterial infection  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Tinea manuum  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Upper respiratory tract infection  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Viral upper respiratory tract infection  1  12/151 (7.95%)  13 9/152 (5.92%)  10
Injury, poisoning and procedural complications     
Animal bite  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Arthropod sting  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Contusion  1  2/151 (1.32%)  2 1/152 (0.66%)  1
Fall  1  2/151 (1.32%)  3 0/152 (0.00%)  0
Foot fracture  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Heat illness  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Skin abrasion  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Skin wound  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Wound  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  1/151 (0.66%)  1 1/152 (0.66%)  1
Aspartate aminotransferase increased  1  1/151 (0.66%)  1 1/152 (0.66%)  1
Blood creatine phosphokinase increased  1  2/151 (1.32%)  2 0/152 (0.00%)  0
Blood creatinine increased  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Blood potassium increased  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Blood pressure increased  1  0/151 (0.00%)  0 2/152 (1.32%)  2
Glycosylated haemoglobin increased  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Weight decreased  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Weight increased  1  2/151 (1.32%)  2 0/152 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  0/151 (0.00%)  0 3/152 (1.97%)  3
Diabetes mellitus  1  2/151 (1.32%)  2 0/152 (0.00%)  0
Dyslipidaemia  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Hyperglycaemia  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Hyperuricaemia  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Hypoglycaemia  1  2/151 (1.32%)  3 3/152 (1.97%)  4
Increased appetite  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Lactic acidosis  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/151 (1.32%)  2 0/152 (0.00%)  0
Back pain  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Muscle spasms  1  2/151 (1.32%)  2 0/152 (0.00%)  0
Musculoskeletal stiffness  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Myalgia  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Periarthritis  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Rhabdomyolysis  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin papilloma  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Nervous system disorders     
Diabetic neuropathy  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Disturbance in attention  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Dizziness  1  22/151 (14.57%)  22 9/152 (5.92%)  11
Dizziness postural  1  1/151 (0.66%)  1 1/152 (0.66%)  1
Headache  1  3/151 (1.99%)  3 3/152 (1.97%)  3
Hypoaesthesia  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Lethargy  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Neuralgia  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Seizure  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Somnolence  1  22/151 (14.57%)  23 19/152 (12.50%)  21
Visual field defect  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Psychiatric disorders     
Anxiety  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Depressive symptom  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Insomnia  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Sleep disorder  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Renal and urinary disorders     
Diabetic nephropathy  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Haematuria  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Hypertonic bladder  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Renal impairment  1  1/151 (0.66%)  1 0/152 (0.00%)  0
Urinary hesitation  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Reproductive system and breast disorders     
Erectile dysfunction  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Prostatomegaly  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Respiratory, thoracic and mediastinal disorders     
Nasal inflammation  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Oropharyngeal pain  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Rhinorrhoea  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Upper respiratory tract inflammation  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Skin and subcutaneous tissue disorders     
Blister  1  1/151 (0.66%)  1 1/152 (0.66%)  1
Diabetic foot  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Dry skin  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Eczema  1  3/151 (1.99%)  3 3/152 (1.97%)  3
Haemorrhage subcutaneous  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Night sweats  1  0/151 (0.00%)  0 1/152 (0.66%)  2
Pruritus generalised  1  0/151 (0.00%)  0 1/152 (0.66%)  1
Rash  1  0/151 (0.00%)  0 2/152 (1.32%)  2
Skin ulcer  1  1/151 (0.66%)  2 0/152 (0.00%)  0
Urticaria  1  1/151 (0.66%)  1 1/152 (0.66%)  1
Vascular disorders     
Hypertension  1  3/151 (1.99%)  3 1/152 (0.66%)  1
Hypotension  1  1/151 (0.66%)  1 1/152 (0.66%)  1
Lymphoedema  1  1/151 (0.66%)  1 0/152 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02417935     History of Changes
Other Study ID Numbers: 14378
F1J-JE-HMHA ( Other Identifier: Eli Lilly and Company )
First Submitted: April 13, 2015
First Posted: April 16, 2015
Results First Submitted: May 11, 2018
Results First Posted: July 10, 2018
Last Update Posted: September 18, 2019