Trial Outcomes & Findings for A Study of Duloxetine (LY248686) in Participants With Diabetic Peripheral Neuropathic Pain (DPNP) (NCT NCT02417935)
NCT ID: NCT02417935
Last Updated: 2019-09-18
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
304 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2019-09-18
Participant Flow
12 week Treatment period, followed by 1 week Tapering period, followed by 1 week follow-up period.
Participant milestones
| Measure |
Pregabalin
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.
|
Duloxetine
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.
|
|---|---|---|
|
Treatment Period
STARTED
|
151
|
153
|
|
Treatment Period
Received at Least One Dose of Study Drug
|
151
|
152
|
|
Treatment Period
COMPLETED
|
130
|
137
|
|
Treatment Period
NOT COMPLETED
|
21
|
16
|
|
Tapering Period
STARTED
|
134
|
142
|
|
Tapering Period
COMPLETED
|
134
|
142
|
|
Tapering Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pregabalin
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.
|
Duloxetine
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.
|
|---|---|---|
|
Treatment Period
Adverse Event
|
12
|
10
|
|
Treatment Period
Lost to Follow-up
|
1
|
0
|
|
Treatment Period
Entry Criteria not met
|
0
|
1
|
|
Treatment Period
Protocol Violation
|
2
|
1
|
|
Treatment Period
Withdrawal by Subject
|
3
|
3
|
|
Treatment Period
Physician Decision
|
3
|
1
|
Baseline Characteristics
A Study of Duloxetine (LY248686) in Participants With Diabetic Peripheral Neuropathic Pain (DPNP)
Baseline characteristics by cohort
| Measure |
Pregabalin
n=151 Participants
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.
|
Duloxetine
n=152 Participants
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
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 9.84 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 8.16 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 9.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
151 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
151 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Numeric Rating Scale (NRS)
Average Pain Score
|
5.35 units on a scale
STANDARD_DEVIATION 1.129 • n=5 Participants
|
5.38 units on a scale
STANDARD_DEVIATION 1.079 • n=7 Participants
|
5.37 units on a scale
STANDARD_DEVIATION 1.102 • n=5 Participants
|
|
Numeric Rating Scale (NRS)
Night Pain Score
|
4.61 units on a scale
STANDARD_DEVIATION 1.855 • n=5 Participants
|
4.92 units on a scale
STANDARD_DEVIATION 1.650 • n=7 Participants
|
4.76 units on a scale
STANDARD_DEVIATION 1.759 • n=5 Participants
|
|
Numeric Rating Scale (NRS)
Worst Pain Score
|
6.25 units on a scale
STANDARD_DEVIATION 1.311 • n=5 Participants
|
6.22 units on a scale
STANDARD_DEVIATION 1.237 • n=7 Participants
|
6.23 units on a scale
STANDARD_DEVIATION 1.273 • n=5 Participants
|
|
Brief Pain Inventory - Short Form (BPI-SF)
Worst Pain
|
6.3 units on a scale
STANDARD_DEVIATION 1.45 • n=5 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 1.24 • n=7 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 1.35 • n=5 Participants
|
|
Brief Pain Inventory - Short Form (BPI-SF)
Least Pain
|
3.8 units on a scale
STANDARD_DEVIATION 1.74 • n=5 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 1.70 • n=7 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 1.72 • n=5 Participants
|
|
Brief Pain Inventory - Short Form (BPI-SF)
Average Pain
|
5.3 units on a scale
STANDARD_DEVIATION 1.21 • n=5 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 1.17 • n=7 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 1.19 • n=5 Participants
|
|
Brief Pain Inventory - Short Form (BPI-SF)
Pain Right Now
|
4.9 units on a scale
STANDARD_DEVIATION 1.60 • n=5 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 1.58 • n=7 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 1.59 • n=5 Participants
|
|
Brief Pain Inventory - Short Form (BPI-SF)
General Activity
|
3.1 units on a scale
STANDARD_DEVIATION 2.14 • n=5 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 2.21 • n=7 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 2.18 • n=5 Participants
|
|
Brief Pain Inventory - Short Form (BPI-SF)
Mood
|
3.3 units on a scale
STANDARD_DEVIATION 2.32 • n=5 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 2.23 • n=7 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 2.28 • n=5 Participants
|
|
Brief Pain Inventory - Short Form (BPI-SF)
Walking Ability
|
2.9 units on a scale
STANDARD_DEVIATION 2.28 • n=5 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 2.51 • n=7 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 2.39 • n=5 Participants
|
|
Brief Pain Inventory - Short Form (BPI-SF)
Normal Work
|
2.6 units on a scale
STANDARD_DEVIATION 2.11 • n=5 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 2.41 • n=7 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 2.26 • n=5 Participants
|
|
Brief Pain Inventory - Short Form (BPI-SF)
Relations With Other People
|
1.4 units on a scale
STANDARD_DEVIATION 1.81 • n=5 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 1.81 • n=7 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 1.80 • n=5 Participants
|
|
Brief Pain Inventory - Short Form (BPI-SF)
Sleep
|
2.7 units on a scale
STANDARD_DEVIATION 2.39 • n=5 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 2.37 • n=7 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 2.38 • n=5 Participants
|
|
Brief Pain Inventory - Short Form (BPI-SF)
Enjoyment of Life
|
2.6 units on a scale
STANDARD_DEVIATION 2.27 • n=5 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 2.24 • n=7 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 2.25 • n=5 Participants
|
|
Brief Pain Inventory - Short Form (BPI-SF)
Average Interference Score
|
2.66 units on a scale
STANDARD_DEVIATION 1.744 • n=5 Participants
|
2.63 units on a scale
STANDARD_DEVIATION 1.875 • n=7 Participants
|
2.64 units on a scale
STANDARD_DEVIATION 1.807 • n=5 Participants
|
|
Beck Depression Inventory-II (BDI-II)
|
6.2 units on a scale
STANDARD_DEVIATION 5.41 • n=5 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 5.90 • n=7 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 5.66 • n=5 Participants
|
|
Neuropathic Pain Symptom Inventory (NPSI)
|
31.8 units on a scale
STANDARD_DEVIATION 15.60 • n=5 Participants
|
32.1 units on a scale
STANDARD_DEVIATION 16.49 • n=7 Participants
|
31.9 units on a scale
STANDARD_DEVIATION 16.03 • n=5 Participants
|
|
EuroQol 5 Dimension (EQ-5D)
|
0.7253 units on a scale
STANDARD_DEVIATION 0.0903 • n=5 Participants
|
0.7337 units on a scale
STANDARD_DEVIATION 0.1230 • n=7 Participants
|
0.7296 units on a scale
STANDARD_DEVIATION 0.1079 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for NRS.
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).
Outcome measures
| Measure |
Pregabalin
n=149 Participants
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
|
Duloxetine
n=152 Participants
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
|
|---|---|---|
|
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)
|
-2.358 units on a scale
Standard Error 0.133
|
-2.286 units on a scale
Standard Error 0.133
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug and had at least one post baseline observation.
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.
Outcome measures
| Measure |
Pregabalin
n=149 Participants
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
|
Duloxetine
n=152 Participants
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
|
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I) at 12 Weeks
|
2.6 units on a scale
Standard Error 0.1
|
2.4 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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.
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.
Outcome measures
| Measure |
Pregabalin
n=149 Participants
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
|
Duloxetine
n=152 Participants
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
|
|---|---|---|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Average Interference
|
-1.60 units on a scale
Standard Error 0.10
|
-1.77 units on a scale
Standard Error 0.10
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Worst Pain
|
-2.8 units on a scale
Standard Error 0.2
|
-2.7 units on a scale
Standard Error 0.2
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Least Pain
|
-1.7 units on a scale
Standard Error 0.1
|
-1.9 units on a scale
Standard Error 0.1
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Average Pain
|
-2.5 units on a scale
Standard Error 0.1
|
-2.4 units on a scale
Standard Error 0.1
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Pain Right Now
|
-2.4 units on a scale
Standard Error 0.1
|
-2.4 units on a scale
Standard Error 0.1
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
General Activity
|
-1.9 units on a scale
Standard Error 0.1
|
-2.1 units on a scale
Standard Error 0.1
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Mood
|
-1.9 units on a scale
Standard Error 0.1
|
-2.1 units on a scale
Standard Error 0.1
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Walking Ability
|
-1.8 units on a scale
Standard Error 0.1
|
-1.9 units on a scale
Standard Error 0.1
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Normal Work
|
-1.6 units on a scale
Standard Error 0.1
|
-1.8 units on a scale
Standard Error 0.1
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Relations with Other People
|
-0.7 units on a scale
Standard Error 0.1
|
-0.9 units on a scale
Standard Error 0.1
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Sleep
|
-1.7 units on a scale
Standard Error 0.1
|
-1.7 units on a scale
Standard Error 0.1
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Enjoyment of Life
|
-1.6 units on a scale
Standard Error 0.1
|
-1.8 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least one dose of study drug \& had baseline \& at least one post-baseline observation for NPSI.
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.
Outcome measures
| Measure |
Pregabalin
n=148 Participants
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
|
Duloxetine
n=151 Participants
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
|
|---|---|---|
|
Change From Baseline to 12 Weeks on the Neuropathic Pain Symptom Inventory (NPSI)
Total Score
|
-15.4 units on a scale
Standard Error 1.1
|
-16.1 units on a scale
Standard Error 1.1
|
|
Change From Baseline to 12 Weeks on the Neuropathic Pain Symptom Inventory (NPSI)
Pressing Pain
|
-1.4 units on a scale
Standard Error 0.1
|
-1.4 units on a scale
Standard Error 0.1
|
|
Change From Baseline to 12 Weeks on the Neuropathic Pain Symptom Inventory (NPSI)
Paresthesia/Dysesthesia
|
-2.5 units on a scale
Standard Error 0.1
|
-2.6 units on a scale
Standard Error 0.1
|
|
Change From Baseline to 12 Weeks on the Neuropathic Pain Symptom Inventory (NPSI)
Burning Pain
|
-1.1 units on a scale
Standard Error 0.2
|
-1.3 units on a scale
Standard Error 0.2
|
|
Change From Baseline to 12 Weeks on the Neuropathic Pain Symptom Inventory (NPSI)
Paroxysmal Pain
|
-1.7 units on a scale
Standard Error 0.1
|
-1.7 units on a scale
Standard Error 0.1
|
|
Change From Baseline to 12 Weeks on the Neuropathic Pain Symptom Inventory (NPSI)
Evoked Pain
|
-1.0 units on a scale
Standard Error 0.1
|
-1.2 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug and had at least one post baseline observation for CGI-I
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.
Outcome measures
| Measure |
Pregabalin
n=149 Participants
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
|
Duloxetine
n=152 Participants
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
|
|---|---|---|
|
Clinical Global Impression of Improvement (CGI-I) at 12 Weeks
|
2.6 units on a scale
Standard Error 0.1
|
2.5 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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.
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.
Outcome measures
| Measure |
Pregabalin
n=148 Participants
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
|
Duloxetine
n=151 Participants
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
|
|---|---|---|
|
Change From Baseline to 12 Weeks on the EuroQol 5 Dimension (EQ-5D)
|
0.1004 units on a scale
Standard Error 0.0112
|
0.1144 units on a scale
Standard Error 0.0112
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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.
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.
Outcome measures
| Measure |
Pregabalin
n=146 Participants
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
|
Duloxetine
n=141 Participants
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
|
|---|---|---|
|
Change From Baseline to 12 Weeks on the Beck Depression Inventory-II (BDI-II) Total Score
|
-2.5 units on a scale
Standard Error 0.3
|
-2.3 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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.
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.
Outcome measures
| Measure |
Pregabalin
n=149 Participants
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
|
Duloxetine
n=152 Participants
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
|
|---|---|---|
|
Change From Baseline to 12 Weeks in the Weekly Mean of Night Pain Scores on the 11-Point NRS
|
-2.166 units on a scale
Standard Error 0.131
|
-2.160 units on a scale
Standard Error 0.131
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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.
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.
Outcome measures
| Measure |
Pregabalin
n=149 Participants
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
|
Duloxetine
n=152 Participants
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
|
|---|---|---|
|
Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Worst Pain Scores on the 11-Point NRS
|
-2.553 units on a scale
Standard Error 0.145
|
-2.416 units on a scale
Standard Error 0.145
|
SECONDARY outcome
Timeframe: Week 12Population: 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 .
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.
Outcome measures
| Measure |
Pregabalin
n=149 Participants
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
|
Duloxetine
n=152 Participants
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
|
|---|---|---|
|
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
50% Reduction
|
62 Participants
|
62 Participants
|
|
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
30% Reduction
|
94 Participants
|
100 Participants
|
Adverse Events
Pregabalin
Serious events: 6 serious events
Other events: 91 other events
Deaths: 0 deaths
Duloxetine
Serious events: 1 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=151 participants at risk
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
|
Duloxetine
n=152 participants at risk
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Infections and infestations
Staphylococcal sepsis
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Vascular disorders
Shock
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
Other adverse events
| Measure |
Pregabalin
n=151 participants at risk
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
|
Duloxetine
n=152 participants at risk
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.
|
|---|---|---|
|
Nervous system disorders
Lethargy
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Nervous system disorders
Neuralgia
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Nervous system disorders
Seizure
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
General disorders
Chest pain
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/151 • Up to 14 weeks
|
1.3%
2/152 • Number of events 2 • Up to 14 weeks
|
|
General disorders
Fatigue
|
0.00%
0/151 • Up to 14 weeks
|
1.3%
2/152 • Number of events 2 • Up to 14 weeks
|
|
Cardiac disorders
Arrhythmia
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
3/151 • Number of events 3 • Up to 14 weeks
|
1.3%
2/152 • Number of events 2 • Up to 14 weeks
|
|
Eye disorders
Diabetic retinopathy
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Eye disorders
Dry eye
|
1.3%
2/151 • Number of events 2 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Eye disorders
Macular oedema
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Eye disorders
Open angle glaucoma
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Eye disorders
Retinopathy
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.3%
2/151 • Number of events 2 • Up to 14 weeks
|
1.3%
2/152 • Number of events 2 • Up to 14 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Gastrointestinal disorders
Constipation
|
2.6%
4/151 • Number of events 4 • Up to 14 weeks
|
3.9%
6/152 • Number of events 6 • Up to 14 weeks
|
|
Gastrointestinal disorders
Diabetic gastroenteropathy
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
5/151 • Number of events 5 • Up to 14 weeks
|
1.3%
2/152 • Number of events 2 • Up to 14 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/151 • Up to 14 weeks
|
1.3%
2/152 • Number of events 2 • Up to 14 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Gastrointestinal disorders
Enteritis
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.3%
2/151 • Number of events 2 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/151 • Up to 14 weeks
|
2.0%
3/152 • Number of events 3 • Up to 14 weeks
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.6%
7/151 • Number of events 7 • Up to 14 weeks
|
7.9%
12/152 • Number of events 13 • Up to 14 weeks
|
|
Gastrointestinal disorders
Periodontal disease
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/151 • Up to 14 weeks
|
2.0%
3/152 • Number of events 4 • Up to 14 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
3.9%
6/152 • Number of events 9 • Up to 14 weeks
|
|
General disorders
Asthenia
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
General disorders
Chest discomfort
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
General disorders
Feeling abnormal
|
2.6%
4/151 • Number of events 4 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
General disorders
Gait disturbance
|
1.3%
2/151 • Number of events 2 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
General disorders
Malaise
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
1.3%
2/152 • Number of events 2 • Up to 14 weeks
|
|
General disorders
Nodule
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
General disorders
Oedema
|
1.3%
2/151 • Number of events 2 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
General disorders
Oedema peripheral
|
2.6%
4/151 • Number of events 4 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
General disorders
Pain
|
1.3%
2/151 • Number of events 2 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
General disorders
Thirst
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
General disorders
Xerosis
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/151 • Up to 14 weeks
|
1.3%
2/152 • Number of events 2 • Up to 14 weeks
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Infections and infestations
Bronchitis
|
1.3%
2/151 • Number of events 2 • Up to 14 weeks
|
1.3%
2/152 • Number of events 2 • Up to 14 weeks
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Infections and infestations
Cystitis
|
1.3%
2/151 • Number of events 3 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/151 • Up to 14 weeks
|
2.0%
3/152 • Number of events 3 • Up to 14 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Infections and infestations
Myringitis
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Infections and infestations
Otitis media
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Infections and infestations
Periodontitis
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Infections and infestations
Pharyngitis
|
1.3%
2/151 • Number of events 2 • Up to 14 weeks
|
1.3%
2/152 • Number of events 5 • Up to 14 weeks
|
|
Infections and infestations
Pyoderma
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Infections and infestations
Tinea manuum
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.9%
12/151 • Number of events 13 • Up to 14 weeks
|
5.9%
9/152 • Number of events 10 • Up to 14 weeks
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
1.3%
2/151 • Number of events 2 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
2/151 • Number of events 3 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Injury, poisoning and procedural complications
Wound
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
1.3%
2/151 • Number of events 2 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Investigations
Blood potassium increased
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Investigations
Blood pressure increased
|
0.00%
0/151 • Up to 14 weeks
|
1.3%
2/152 • Number of events 2 • Up to 14 weeks
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Investigations
Weight increased
|
1.3%
2/151 • Number of events 2 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/151 • Up to 14 weeks
|
2.0%
3/152 • Number of events 3 • Up to 14 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.3%
2/151 • Number of events 2 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
2/151 • Number of events 3 • Up to 14 weeks
|
2.0%
3/152 • Number of events 4 • Up to 14 weeks
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
2/151 • Number of events 2 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.3%
2/151 • Number of events 2 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Nervous system disorders
Diabetic neuropathy
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Nervous system disorders
Dizziness
|
14.6%
22/151 • Number of events 22 • Up to 14 weeks
|
5.9%
9/152 • Number of events 11 • Up to 14 weeks
|
|
Nervous system disorders
Dizziness postural
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Nervous system disorders
Headache
|
2.0%
3/151 • Number of events 3 • Up to 14 weeks
|
2.0%
3/152 • Number of events 3 • Up to 14 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Nervous system disorders
Somnolence
|
14.6%
22/151 • Number of events 23 • Up to 14 weeks
|
12.5%
19/152 • Number of events 21 • Up to 14 weeks
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Renal and urinary disorders
Renal impairment
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.0%
3/151 • Number of events 3 • Up to 14 weeks
|
2.0%
3/152 • Number of events 3 • Up to 14 weeks
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 2 • Up to 14 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/151 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/151 • Up to 14 weeks
|
1.3%
2/152 • Number of events 2 • Up to 14 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.66%
1/151 • Number of events 2 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Vascular disorders
Hypertension
|
2.0%
3/151 • Number of events 3 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Vascular disorders
Hypotension
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.66%
1/152 • Number of events 1 • Up to 14 weeks
|
|
Vascular disorders
Lymphoedema
|
0.66%
1/151 • Number of events 1 • Up to 14 weeks
|
0.00%
0/152 • Up to 14 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60