Trial Outcomes & Findings for Efficacy and Safety of Gabapentin/B-complex Versus Pregabalin in Diabetic Peripheral Neuropathy Pain Management (NCT NCT01364298)
NCT ID: NCT01364298
Last Updated: 2014-02-06
Results Overview
An average NPIS pain score (daily average records of the past seven days) was evaluated. Numeric pain intensity scale (NPIS) is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. Change from baseline data has been calculated as value at baseline minus value at Day 84.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
353 participants
Primary outcome timeframe
Baseline and Day 84 (Week 12)
Results posted on
2014-02-06
Participant Flow
Participant milestones
| Measure |
Gabapentin/B-complex
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Pregabalin
Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
|---|---|---|
|
Overall Study
STARTED
|
176
|
177
|
|
Overall Study
Treated
|
174
|
174
|
|
Overall Study
COMPLETED
|
162
|
154
|
|
Overall Study
NOT COMPLETED
|
14
|
23
|
Reasons for withdrawal
| Measure |
Gabapentin/B-complex
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Pregabalin
Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
|
Overall Study
Lack of adherence to treatment
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
10
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Other
|
1
|
3
|
Baseline Characteristics
Efficacy and Safety of Gabapentin/B-complex Versus Pregabalin in Diabetic Peripheral Neuropathy Pain Management
Baseline characteristics by cohort
| Measure |
Gabapentin/B-complex
n=174 Participants
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Pregabalin
n=174 Participants
Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Total
n=348 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 10.5 • n=39 Participants
|
54.3 years
STANDARD_DEVIATION 9.4 • n=41 Participants
|
53.8 years
STANDARD_DEVIATION 9.9 • n=35 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=39 Participants
|
109 Participants
n=41 Participants
|
228 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=39 Participants
|
65 Participants
n=41 Participants
|
120 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 84 (Week 12)Population: Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.
An average NPIS pain score (daily average records of the past seven days) was evaluated. Numeric pain intensity scale (NPIS) is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. Change from baseline data has been calculated as value at baseline minus value at Day 84.
Outcome measures
| Measure |
Gabapentin/B-complex
n=147 Participants
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Pregabalin
n=123 Participants
Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
|---|---|---|
|
Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84
Change at Day 84 (n=146, 122)
|
3.905 units on a scale
Standard Deviation 2.639
|
4.260 units on a scale
Standard Deviation 2.329
|
|
Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84
Baseline (n=147, 123)
|
6.7 units on a scale
Standard Deviation 1.5
|
6.8 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline and Day 84 (Week 12)Population: Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.
The LANSS scale score is 7-item pain scale that consists of grouped sensory description and sensory examination with simple scoring system. Evaluations in two main areas: pain and sensorial exploration. The first 5 questions asks for presence of unpleasant skin sensations (pricking, tingling, pins and needles), appearance of skin (mottled, red, or pink), increased sensitivity of skin to touch, sudden bursts of electric shock sensations, and hot or burning skin sensations. Last 2 questions involve sensory testing for the presence of allodynia and altered pinprick threshold. Different numbers of points, relative to their significance to neuropathic pain, are given to positive answers for maximum of 24 points. A score less than 12 makes unlikely that participant's symptoms are neuropathic in nature, whereas score more than 12 make neuropathic mechanisms likely to be contributing to participant's pain. Change from baseline data has been calculated as value at baseline minus value at Day 84.
Outcome measures
| Measure |
Gabapentin/B-complex
n=147 Participants
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Pregabalin
n=123 Participants
Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
|---|---|---|
|
Change From Baseline in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score at Day 84
Baseline (n=147, 123)
|
16.2 units on a scale
Standard Deviation 3.6
|
15.8 units on a scale
Standard Deviation 4.0
|
|
Change From Baseline in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score at Day 84
Change at Day 84 (n=146, 122)
|
8.082 units on a scale
Standard Deviation 7.470
|
6.967 units on a scale
Standard Deviation 6.839
|
SECONDARY outcome
Timeframe: Baseline and Day 84 (Week 12)Population: Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.
VAS is used to rate the pain as per 10 centimeter (cm) line. The pain intensity score ranges from '0=no pain' to '10=worst possible pain'. Change from baseline data has been calculated as value at baseline minus value at Day 84.
Outcome measures
| Measure |
Gabapentin/B-complex
n=147 Participants
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Pregabalin
n=123 Participants
Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
|---|---|---|
|
Change From Baseline in Visual Analogue Scale (VAS) Score at Day 84
Baseline (n=147, 123)
|
7.0 centimeter
Standard Deviation 1.8
|
7.1 centimeter
Standard Deviation 1.5
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score at Day 84
Change at Day 84 (n=146, 122)
|
4.182 centimeter
Standard Deviation 2.890
|
4.529 centimeter
Standard Deviation 2.382
|
SECONDARY outcome
Timeframe: Day 84 (Week 12)Population: Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.
POMS is a rating scale, which comprises of 65 items that are evaluated in a 0-4 scale, where 0 means "not at all" and 4 "extremely". The scores for the 65 items are added in various combinations to throw six validated factors which are used to calculate total POMS score: (tension-anxiety) + (depression-dejection) + (anger-hostility)+ (fatigue-Inertia) + (confusion-bewilderment) - (vigor-activity). Score range (-40 to 192). Score -40 denotes the best score and score 192 denotes the worst score.
Outcome measures
| Measure |
Gabapentin/B-complex
n=147 Participants
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Pregabalin
n=123 Participants
Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
|---|---|---|
|
Profile of Mood States (POMS) Score
|
1.3 units on a scale
Standard Deviation 26.1
|
3.4 units on a scale
Standard Deviation 25.5
|
SECONDARY outcome
Timeframe: Day 84 (Week 12)Population: Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.
Sleep evaluation was performed by assessing number of participants who fell asleep in a particular pre-specified range of time duration, that is, 0-15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes and greater than 60 minutes at Day 84 (Week 12).
Outcome measures
| Measure |
Gabapentin/B-complex
n=147 Participants
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Pregabalin
n=123 Participants
Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
|---|---|---|
|
Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration
0 to 15 minutes
|
85 participants
6.2
|
72 participants
5.4
|
|
Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration
16 to 30 minutes
|
33 participants
2.8
|
33 participants
2.9
|
|
Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration
31 to 45 minutes
|
13 participants
|
12 participants
|
|
Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration
46 to 60 minutes
|
8 participants
|
4 participants
|
|
Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration
Greater than 60 minutes
|
8 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline and Day 84 (Week 12)Population: Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
GIPC is an assessment that the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse).
Outcome measures
| Measure |
Gabapentin/B-complex
n=145 Participants
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Pregabalin
n=122 Participants
Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
|---|---|---|
|
Number of Participants With Various Health Conditions Based on Global Impression of Patient Change (GIPC) Scale
Health: extremely improved
|
62 participants
|
47 participants
|
|
Number of Participants With Various Health Conditions Based on Global Impression of Patient Change (GIPC) Scale
Health: much improved
|
73 participants
|
65 participants
|
|
Number of Participants With Various Health Conditions Based on Global Impression of Patient Change (GIPC) Scale
Health: minimally improved
|
10 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Baseline and Day 84 (Week 12)Population: Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
CGIC is an assessment that the physician performs to assess the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse).
Outcome measures
| Measure |
Gabapentin/B-complex
n=145 Participants
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Pregabalin
n=122 Participants
Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
|---|---|---|
|
Number of Participants With Various Health Conditions Based on Clinical Global Impression of Change (CGIC) Scale
Health: extremely improved
|
55 participants
|
47 participants
|
|
Number of Participants With Various Health Conditions Based on Clinical Global Impression of Change (CGIC) Scale
Health: much improved
|
79 participants
|
69 participants
|
|
Number of Participants With Various Health Conditions Based on Clinical Global Impression of Change (CGIC) Scale
Health: minimally improved
|
11 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Baseline and Day 84 (Week 12)Population: Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.
NPIS is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours.
Outcome measures
| Measure |
Gabapentin/B-complex
n=147 Participants
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Pregabalin
n=123 Participants
Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
|---|---|---|
|
Percentage of Participants With at Least 30 and 50 Percent (%) Improvement in Numeric Pain Intensity Scale (NPIS) From Baseline at Day 84 (Week 12)
At least 30% improvement
|
76.9 percentage of participants
|
85.4 percentage of participants
|
|
Percentage of Participants With at Least 30 and 50 Percent (%) Improvement in Numeric Pain Intensity Scale (NPIS) From Baseline at Day 84 (Week 12)
At least 50% improvement
|
66.0 percentage of participants
|
72.4 percentage of participants
|
SECONDARY outcome
Timeframe: Day 7 up to Day 84 (+7 days)Population: Safety population included all the randomized participants who received at least one dose of study drug.
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.
Outcome measures
| Measure |
Gabapentin/B-complex
n=174 Participants
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Pregabalin
n=174 Participants
Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
80 participants
|
93 participants
|
Adverse Events
Gabapentin/B-complex
Serious events: 1 serious events
Other events: 79 other events
Deaths: 0 deaths
Pregabalin
Serious events: 0 serious events
Other events: 93 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gabapentin/B-complex
n=174 participants at risk
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Pregabalin
n=174 participants at risk
Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular disorder
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
Other adverse events
| Measure |
Gabapentin/B-complex
n=174 participants at risk
Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
Pregabalin
n=174 participants at risk
Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.1%
2/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Asthenia
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Eye disorders
Cataract
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Colitis
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Toothache
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
5/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
3.4%
6/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Insomnia
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
2.3%
4/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.1%
2/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Flatulence
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Gastritis
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.1%
2/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Constipation
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Headache
|
8.0%
14/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
7.5%
13/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Angina pectoris
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Nausea
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
2.9%
5/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.7%
3/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Dizziness
|
18.4%
32/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
29.9%
52/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Somnolence
|
23.6%
41/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
29.9%
52/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Ear and labyrinth disorders
Vertigo
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
6.3%
11/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Gait disturbance
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
3.4%
6/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Vascular insufficiency
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Eye disorders
Eye irritation
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Oedema
|
1.1%
2/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.7%
3/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Dry mouth
|
1.1%
2/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Odynophagia
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Paraesthesia
|
1.1%
2/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Weight increased
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Pityriasis
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Pharyngitis
|
1.1%
2/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
1.1%
2/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
2/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
4.6%
8/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Hypertension
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Eye disorders
Vision blurred
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.57%
1/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
0.00%
0/174 • Day 7 up to Day 84 (+ 7 days)
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place