Trial Outcomes & Findings for Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN) (NCT NCT01474772)
NCT ID: NCT01474772
Last Updated: 2021-01-28
Results Overview
The daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via Interactive Voice Recognition System (IVRS). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.
COMPLETED
PHASE3
217 participants
End of Period (includes both Visits 6 and 11)
2021-01-28
Participant Flow
411 participants were screened, of whom 206 were withdrawn before randomization. 205 were randomized, of whom 2 discontinued before being treated. Participants were randomized at 36 centers in 4 countries: US (25), Sweden (4), South Africa (4), and Czech Republic (3). 11 centers received study drug but did not randomize participants.
Participants completed daily pain and sleep diary from Visit 1 (V1; Screening) to Visit 12 (V12; Follow-up). Participants with a mean pain score ≥ 4 (moderate to severe pain) and those meeting the pain on walking criteria (post-walk pain score ≥ 4, and \> the pre-walk pain score at V1 and Visit 2 \[V2; Baseline\]) were randomized.
Participant milestones
| Measure |
Pregabalin/Placebo
Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration \[starting dose: 150 mg/day\] and 4 weeks fixed dose \[150 - 300 mg/day\]) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo/Pregablin
Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (2 week dose titration \[starting dose: 150 mg/day\] and 4 weeks fixed dose \[150 - 300 mg/day\]). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Period 1
STARTED
|
101
|
102
|
|
Period 1
COMPLETED
|
89
|
99
|
|
Period 1
NOT COMPLETED
|
12
|
3
|
|
Washout
STARTED
|
89
|
99
|
|
Washout
COMPLETED
|
86
|
97
|
|
Washout
NOT COMPLETED
|
3
|
2
|
|
Period 2
STARTED
|
86
|
97
|
|
Period 2
COMPLETED
|
77
|
87
|
|
Period 2
NOT COMPLETED
|
9
|
10
|
|
Follow-up
STARTED
|
77
|
87
|
|
Follow-up
COMPLETED
|
77
|
86
|
|
Follow-up
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Pregabalin/Placebo
Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration \[starting dose: 150 mg/day\] and 4 weeks fixed dose \[150 - 300 mg/day\]) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo/Pregablin
Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (2 week dose titration \[starting dose: 150 mg/day\] and 4 weeks fixed dose \[150 - 300 mg/day\]). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Period 1
Adverse Event (AE) Related to Study Drug
|
6
|
1
|
|
Period 1
AE not Related to Study Drug
|
1
|
0
|
|
Period 1
Withdrawal by Subject
|
3
|
1
|
|
Period 1
Lost to Follow-up
|
1
|
0
|
|
Period 1
Reason not Specified
|
1
|
1
|
|
Washout
AE not Related to Study Drug
|
2
|
0
|
|
Washout
Withdrawal by Subject
|
1
|
0
|
|
Washout
Lost to Follow-up
|
0
|
1
|
|
Washout
Reason not Specified
|
0
|
1
|
|
Period 2
Death
|
0
|
1
|
|
Period 2
AE Related to Study Drug
|
0
|
1
|
|
Period 2
AE not Related to Study Drug
|
4
|
1
|
|
Period 2
Lack of Efficacy
|
1
|
0
|
|
Period 2
Withdrawal by Subject
|
3
|
4
|
|
Period 2
Lost to Follow-up
|
1
|
1
|
|
Period 2
Reason not Specified
|
0
|
2
|
|
Follow-up
AE not Related to Study Drug
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
Baseline characteristics by cohort
| Measure |
Pregabalin/Placebo
n=101 Participants
Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration \[starting dose: 150 mg/day\] and 4 weeks fixed dose \[150 - 300 mg/day\]) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo/Pregabalin
n=102 Participants
Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (2 week dose titration \[starting dose: 150 mg/day\] and 4 weeks fixed dose \[150 - 300 mg/day\]). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.1 Years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
58.4 Years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
58.7 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the Intent-to-Treat (ITT) analysis (N: 203). This was the primary analysis set.
The daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via Interactive Voice Recognition System (IVRS). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)
|
4.73 units on a scale
Standard Error 0.14
|
4.96 units on a scale
Standard Error 0.14
|
PRIMARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
The post-test DPN pain on walking NRS consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their DPN pain in their legs and/or feet while walking during the 50-foot walk test by choosing the appropriate number between 0 and 10. The post-test DPN pain on walking NRS was completed by the participant using paper-pen administration immediately after completing the 50-foot walk test at the end of each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period)
|
4.28 units on a scale
Standard Error 0.15
|
4.41 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).
The daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)
V6 (N: 101, 102)
|
38.6 percentage of participants
|
24.5 percentage of participants
|
|
Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)
V11 (N: 97, 84)
|
46.4 percentage of participants
|
47.6 percentage of participants
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).
The daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)
V6 (N: 101, 102)
|
23.8 percentage of participants
|
13.7 percentage of participants
|
|
Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)
V11 (N: 97, 84)
|
27.8 percentage of participants
|
32.1 percentage of participants
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain (0: no pain; 10: worst pain possible) at its "worst, "least", "average", and "now" (current pain) on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)
|
16.76 units on a scale
Standard Error 0.56
|
17.56 units on a scale
Standard Error 0.75
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain (0: no pain; 10: worst pain possible) at its "worst, "least", "average", and "now" (current pain) on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)
|
22.58 units on a scale
Standard Error 0.96
|
23.75 units on a scale
Standard Error 0.98
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference. The sub-score pain interference with walking ability was evaluated, as it was considered to be the most relevant in the context of this study.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period)
|
3.75 units on a scale
Standard Error 0.17
|
3.93 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the "day" (non-sleep period). Actigraphy was performed with an accelerometer that was worn on the hip during the waking hours. It was programmed to record movements while the device was being worn.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Daytime Total Activity Counts Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)
|
64703.14 counts
Standard Error 4005.00
|
64139.75 counts
Standard Error 4057.89
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. The participants were instructed to wear the device on their hip during the waking hours.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)
|
3785.65 steps
Standard Error 201.17
|
3788.28 steps
Standard Error 203.05
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
The Walk-12 is a self-administered questionnaire that assesses the impact of the participant's diabetic neuropathy over the past 2 weeks on parameters associated with walking (12 questions) based on a 5-point scale (from not at all to extremely). The total score is the sum of scores from the 12 questions, which then gets transferred to a 0-100 scale with higher scores indicating greater impairment
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Walk 12 Questionnaire Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)
|
35.72 units on a scale
Standard Error 1.44
|
37.08 units on a scale
Standard Error 1.46
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). In question 31, "good", the middle item, is scored as 0, "very good" as -1, "excellent" as -2, "fair" as 1, and "poor" as 2. In question 32, "about the same", the middle item, is scored as 0, "somewhat better" as -1, "much better" as -2, "somewhat worse" as 1, and "much worse" as 2. TQOL score should be summed as follow: sum (Σ) (1 - 7, 8 - 35). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)
|
29.31 units on a scale
Standard Error 1.17
|
30.77 units on a scale
Standard Error 1.19
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). In question 31, "good", the middle item, is scored as 0, "very good" as -1, "excellent" as -2, "fair" as 1, and "poor" as 2. In question 32, "about the same", the middle item, is scored as 0, "somewhat better" as -1, "much better" as -2, "somewhat worse" as 1, and "much worse" as 2. The symptoms domain score should be summed as follow: Σ(1 - 7, 9). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Norfolk QOL-DN Symptoms Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)
|
7.65 units on a scale
Standard Error 0.32
|
7.99 units on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). In question 31, "good", the middle item, is scored as 0, "very good" as -1, "excellent" as -2, "fair" as 1, and "poor" as 2. In question 32, "about the same", the middle item, is scored as 0, "somewhat better" as -1, "much better" as -2, "somewhat worse" as 1, and "much worse" as 2. The activities of daily living domain score should be summed as follow: Σ(12, 22, 23, 25, 26). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Norfolk QOL-DN Activities of Daily Living Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)
|
2.36 units on a scale
Standard Error 0.19
|
2.42 units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). In question 31, "good", the middle item, is scored as 0, "very good" as -1, "excellent" as -2, "fair" as 1, and "poor" as 2. In question 32, "about the same", the middle item, is scored as 0, "somewhat better" as -1, "much better" as -2, "somewhat worse" as 1, and "much worse" as 2. The physical functioning / large fiber domain score should be summed as follow: Σ(8, 11, 13 - 15, 24, 27 - 35). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)
|
15.51 units on a scale
Standard Error 0.73
|
16.78 units on a scale
Standard Error 0.75
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). In question 31, "good", the middle item, is scored as 0, "very good" as -1, "excellent" as -2, "fair" as 1, and "poor" as 2. In question 32, "about the same", the middle item, is scored as 0, "somewhat better" as -1, "much better" as -2, "somewhat worse" as 1, and "much worse" as 2. The small fiber domain score should be summed as follow: Σ(10, 16, 17, 18). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Norfolk QOL-DN Small Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)
|
2.77 units on a scale
Standard Error 0.17
|
2.53 units on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). In question 31, "good", the middle item, is scored as 0, "very good" as -1, "excellent" as -2, "fair" as 1, and "poor" as 2. In question 32, "about the same", the middle item, is scored as 0, "somewhat better" as -1, "much better" as -2, "somewhat worse" as 1, and "much worse" as 2. The autonomic domain score should be summed as follow: Σ(19, 20, 21). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Norfolk QOL-DN Autonomic Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)
|
1.07 units on a scale
Standard Error 0.10
|
1.08 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: End of Period 1 (V6)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).
The PGIC is a participant-rated instrument that measures the participant's assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Original scores (OS; 7 different scores) and categorized scores (CS; 4 different scores) were provided. Categorized scores were very much improved (consisting of very much improved and much improved); any improvement (consisting of very much improved, much improved, and minimally improved); no change (consisting of no change); and any worsening (consisting of minimally worse, much worse, and very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V6).
Outcome measures
| Measure |
Pregabalin
n=98 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=102 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)
OS: Very much improved
|
11.2 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)
OS: Much improved
|
39.8 percentage of participants
|
25.5 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)
OS: Minimally improved
|
30.6 percentage of participants
|
27.5 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)
OS: No change
|
13.3 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)
OS: Minimally worse
|
2.0 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)
OS: Much worse
|
2.0 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)
OS: Very much worse
|
1.0 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)
CS: Very much improved
|
51.0 percentage of participants
|
31.4 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)
CS: Any improvement
|
81.6 percentage of participants
|
58.8 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)
CS: No change
|
13.3 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)
CS: Any worsening
|
5.1 percentage of participants
|
7.8 percentage of participants
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
The daily sleep diary consists of an 11-point numeric rating scale with which the participant rates how painful DPN pain has interfered with their sleep during the past 24 hours. Zero indicates "does not interfere with sleep" and 10 indicates "completely interferes (unable to sleep due to pain)". Self-assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight) after completion of the daily pain diary.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
|
3.66 units on a scale
Standard Error 0.12
|
4.05 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
|
4.65 units on a scale
Standard Error 0.19
|
4.92 units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
The HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
|
3.73 units on a scale
Standard Error 0.20
|
3.97 units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: End of Period (includes both Visits 6 and 11)Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.
The EQ-5D describes participant's health status based on 5 attributes producing an 5 digit index score. The 5 dimensions are: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Dolan 1997 advised how to transfer this index score to a single score for clinical trials, a revised single index was published in 2001. The index uses general population weighted estimates for various health states. In general, the range of the single index tends to vary between 0 = death and 1 = perfect health and there are some states that have been rated by the general population to be worse than death which may result in numbers below 0.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Euro QoL-5 Dimensions (EQ-5D) - Health State Profile Utility Scores at the End of Each Treatment Period (Week 6 of Each Treatment Period)
Index score Dolan 1997
|
0.649 units on a scale
Standard Error 0.015
|
0.643 units on a scale
Standard Error 0.015
|
|
Euro QoL-5 Dimensions (EQ-5D) - Health State Profile Utility Scores at the End of Each Treatment Period (Week 6 of Each Treatment Period)
Index score Dolan 2001
|
0.650 units on a scale
Standard Error 0.014
|
0.641 units on a scale
Standard Error 0.014
|
POST_HOC outcome
Timeframe: Baseline, 6 weeks in Period 1, 2 weeks washout and 6 weeks in Period 2Population: All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).
The daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The longitudinal mean weekly DPN pain scores were defined as the mean of 7 daily diary pain ratings. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.
Outcome measures
| Measure |
Pregabalin
n=198 Participants
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 Participants
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Average Weekly DPN Pain Based on a NRS (Baseline, 6 Weeks in Period 1, 2 Weeks Washout and 6 Weeks in Period 2)
V6 (N: 101, 102)
|
4.66 units on a scale
Standard Deviation 1.77
|
5.29 units on a scale
Standard Deviation 1.93
|
|
Average Weekly DPN Pain Based on a NRS (Baseline, 6 Weeks in Period 1, 2 Weeks Washout and 6 Weeks in Period 2)
V11 (N: 97, 84)
|
4.57 units on a scale
Standard Deviation 2.22
|
4.38 units on a scale
Standard Deviation 2.17
|
Adverse Events
Pregabalin
Placebo
Serious adverse events
| Measure |
Pregabalin
n=198 participants at risk
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 participants at risk
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.51%
1/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Myocardial infarction
|
0.51%
1/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.51%
1/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Diverticulitis
|
0.51%
1/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.54%
1/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urosepsis
|
0.51%
1/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.51%
1/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.51%
1/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.51%
1/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.51%
1/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Drug withdrawal convulsions
|
0.51%
1/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Fracture treatment
|
0.51%
1/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.54%
1/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Pregabalin
n=198 participants at risk
The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
Placebo
n=186 participants at risk
The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
|
|---|---|---|
|
Eye disorders
Vision blurred
|
2.0%
4/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.54%
1/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
1.5%
3/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
4/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
2/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.7%
5/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
2.5%
5/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.54%
1/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
5/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
6/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
5.6%
11/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
3/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
4.5%
9/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
2/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
5/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
8/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
2.5%
5/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.54%
1/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
4/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.54%
1/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
5.6%
11/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
6/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
2.5%
5/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
8/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
6.1%
12/198 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
4/186 • From the time that the participants were provided the informed consent document through and including 28 calendar days after the last administration of the study drug.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER