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Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT01057693
Recruitment Status : Completed
First Posted : January 27, 2010
Results First Posted : February 22, 2013
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetic Neuropathy, Painful
Interventions Drug: pregabalin (Lyrica)
Drug: Placebo
Enrollment 633
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pregabalin SB Pregabalin DB Placebo
Hide Arm/Group Description Participants who were inadequately controlled on their current diabetic peripheral neuropathy (DPN) treatment were switched to single-blind (SB) pregabalin capsules at a starting dose of 150 milligram per day (mg/day) and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced greater than or equal to (>=) 30 percent (%) pain reduction from baseline to Week 6 were eligible for double-blind (DB) treatment phase. Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Period Title: Single-Blind Phase (Up to Week 6)
Started 665 0 0
Completed 566 0 0
Not Completed 99 0 0
Reason Not Completed
Adverse Event             45             0             0
Lack of Efficacy             7             0             0
Lost to Follow-up             14             0             0
Protocol Violation             9             0             0
Withdrawal by Subject             22             0             0
Other             2             0             0
Period Title: Between Single-Blind and Double-Blind
Started 566 0 0
Completed 296 0 0
Not Completed 270 0 0
Reason Not Completed
Adverse Event             5             0             0
Lack of Efficacy             247             0             0
Lost to Follow-up             1             0             0
Protocol Violation             7             0             0
Withdrawal by Subject             4             0             0
Other             6             0             0
Period Title: Double-Blind Phase (Week 7 to Week 19)
Started 0 147 149
Treated 0 147 147
Completed 0 125 113
Not Completed 0 22 36
Reason Not Completed
Adverse Event             0             8             11
Lack of Efficacy             0             3             8
Lost to Follow-up             0             2             5
Protocol Violation             0             0             4
Withdrawal by Subject             0             8             6
Other             0             1             0
Randomized, Not Treated             0             0             2
Arm/Group Title Pregabalin SB
Hide Arm/Group Description Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
Overall Number of Baseline Participants 665
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 665 participants
18 to 44 Years 58
45 to 64 Years 417
>=65 Years 190
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 665 participants
Female
302
  45.4%
Male
363
  54.6%
1.Primary Outcome
Title Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase
Hide Description Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
Time Frame SB Baseline, Week 19 (DB Phase)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF).
Arm/Group Title Pregabalin DB Placebo
Hide Arm/Group Description:
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Overall Number of Participants Analyzed 147 147
Mean (Standard Deviation)
Unit of Measure: units on a scale
Single-Blind Baseline 6.8  (1.24) 6.7  (1.32)
Change at Week 19 (DB Phase) -3.9  (1.92) -3.5  (2.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin DB, Placebo
Comments P-value was calculated using analysis of covariance (ANCOVA), with terms for baseline mean pain score, center and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1221
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.74 to 0.09
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to Loss of Pain Response (Double-Blind Phase)
Hide Description Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
Time Frame SB Baseline up to Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.
Arm/Group Title Pregabalin DB Placebo
Hide Arm/Group Description:
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Overall Number of Participants Analyzed 147 147
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and 95% confidence interval (CI) were not estimable because less than 50% participants experienced loss of pain response.
3.Secondary Outcome
Title Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase
Hide Description Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
Time Frame SB Baseline, Week 6 (SB Phase)
Hide Outcome Measure Data
Hide Analysis Population Description
Single-Blind Analysis Set (SBAS) included all participants who were enrolled in single-blind treatment phase and received at least 1 dose of study treatment. “N” (number of participants analyzed): participants who were evaluable for this measure and “n”: participants who were evaluable for specified time-point. Missing data were imputed using LOCF.
Arm/Group Title Pregabalin SB
Hide Arm/Group Description:
Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
Overall Number of Participants Analyzed 663
Mean (Standard Deviation)
Unit of Measure: units on a scale
SB Baseline (n= 663) 6.7  (1.27)
Change at Week 6 (SB Phase) (n= 658) -2.2  (2.03)
4.Secondary Outcome
Title Weekly Mean Pain Scores (Single-Blind Phase)
Hide Description Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain.
Time Frame Week 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
SBAS included all participants who were enrolled in single-blind treatment phase and received at least one dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time-point.
Arm/Group Title Pregabalin SB
Hide Arm/Group Description:
Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
Overall Number of Participants Analyzed 657
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 (n= 657) 6.0  (1.62)
Week 2 (n= 636) 5.4  (1.82)
Week 3 (n= 613) 4.9  (1.93)
Week 4 (n= 585) 4.6  (1.93)
Week 5 (n= 565) 4.5  (1.92)
Week 6 (n= 548) 4.3  (2.02)
5.Secondary Outcome
Title Weekly Mean Pain Scores (Double-Blind Phase)
Hide Description Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1.
Time Frame DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.
Arm/Group Title Pregabalin DB Placebo
Hide Arm/Group Description:
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Overall Number of Participants Analyzed 147 147
Mean (Standard Deviation)
Unit of Measure: units on a scale
DB Baseline (n= 147, 147) 3.1  (1.42) 3.0  (1.40)
Week 7 (n= 144, 145) 3.2  (1.60) 3.3  (1.80)
Week 8 (n= 143, 142) 3.2  (1.72) 3.6  (1.79)
Week 9 (n= 140, 133) 3.0  (1.65) 3.4  (1.76)
Week 10 (n= 138, 133) 3.0  (1.70) 3.4  (1.77)
Week 11 (n= 138, 128) 2.9  (1.64) 3.3  (1.63)
Week 12 (n= 135, 123) 2.9  (1.68) 3.2  (1.70)
Week 13 (n= 134, 122) 2.9  (1.68) 3.1  (1.69)
Week 14 (n= 133, 122) 2.9  (1.64) 3.1  (1.70)
Week 15 (n= 131, 118) 2.9  (1.63) 3.0  (1.64)
Week 16 (n= 132, 118) 2.8  (1.65) 3.0  (1.58)
Week 17 (n= 128, 115) 2.7  (1.61) 2.9  (1.70)
Week 18 (n= 128, 115) 2.8  (1.66) 2.9  (1.73)
Week 19 (n= 115, 104) 2.7  (1.57) 2.8  (1.71)
6.Secondary Outcome
Title Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)
Hide Description Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF.
Arm/Group Title Pregabalin SB
Hide Arm/Group Description:
Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
Overall Number of Participants Analyzed 665
Measure Type: Number
Unit of Measure: percentage of participants
>=30 % Reduction 49.92
>=50 % Reduction 27.22
7.Secondary Outcome
Title Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)
Hide Description Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported.
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF.
Arm/Group Title Pregabalin DB Placebo
Hide Arm/Group Description:
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Overall Number of Participants Analyzed 147 147
Measure Type: Number
Unit of Measure: percentage of participants
>=30% Reduction 82.99 79.19
>=50% Reduction 62.59 55.03
8.Secondary Outcome
Title Patient Global Impression of Change (PGIC) (Single-Blind Phase)
Hide Description PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Pregabalin SB
Hide Arm/Group Description:
Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
Overall Number of Participants Analyzed 620
Measure Type: Number
Unit of Measure: participants
Very Much Improved 93
Much Improved 221
Minimally Improved 194
No Change 65
Minimally Worse 29
Much Worse 15
Very Much Worse 3
9.Secondary Outcome
Title Patient Global Impression of Change (PGIC) (Double-Blind Phase)
Hide Description PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Pregabalin DB Placebo
Hide Arm/Group Description:
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Overall Number of Participants Analyzed 138 134
Measure Type: Number
Unit of Measure: participants
Very Much Improved 23 23
Much Improved 50 46
Minimally Improved 27 28
No Change 28 20
Minimally Worse 9 6
Much Worse 1 8
Very Much Worse 0 3
10.Secondary Outcome
Title Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)
Hide Description Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.
Time Frame SB Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication. Here “n” signifies participants who were evaluable for specified time-point.
Arm/Group Title Pregabalin SB
Hide Arm/Group Description:
Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
Overall Number of Participants Analyzed 665
Mean (Standard Deviation)
Unit of Measure: units on a scale
SB Baseline: Sleep disturbance (n= 665) 53.6  (24.00)
SB Baseline: Snoring (n= 664) 44.7  (34.73)
SB Baseline: Awaken SOB or With Headache (n=665) 18.9  (24.18)
SB Baseline: Quantity of sleep (n=663) 5.9  (1.40)
SB Baseline: Sleep Adequacy (n=665) 39.2  (23.22)
SB Baseline: Somnolence (n=665) 42.6  (23.49)
SB Baseline: Sleep Problems Index (n=665) 49.2  (18.17)
Week 6: Sleep disturbance (n= 621) 33.6  (24.31)
Week 6: Snoring (n= 621) 39.9  (34.83)
Week 6: Awaken SOB or With Headache (n= 621) 12.6  (22.64)
Week 6: Quantity of sleep (n= 615) 6.6  (1.64)
Week 6: Sleep Adequacy (n= 621) 52.6  (25.55)
Week 6: Somnolence (n= 621) 34.2  (24.11)
Week 6: Sleep Problems Index (n= 621) 34.4  (18.82)
11.Secondary Outcome
Title Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase)
Hide Description Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Pregabalin DB Placebo
Hide Arm/Group Description:
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Overall Number of Participants Analyzed 138 134
Mean (Standard Deviation)
Unit of Measure: units on a scale
Sleep disturbance 26.6  (21.69) 30.9  (23.05)
Snoring 41.9  (36.24) 35.4  (35.95)
Awaken SOB or With Headache 12.3  (23.72) 12.2  (23.89)
Quantity of sleep 6.7  (1.34) 6.5  (1.47)
Sleep Adequacy 59.2  (28.67) 59.0  (27.67)
Somnolence 29.7  (24.39) 30.6  (22.98)
Sleep Problems Index 28.5  (17.86) 30.9  (18.59)
12.Secondary Outcome
Title Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase)
Hide Description MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.
Time Frame SB Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication.
Arm/Group Title Pregabalin SB
Hide Arm/Group Description:
Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
Overall Number of Participants Analyzed 665
Measure Type: Number
Unit of Measure: participants
SB Baseline 180
Week 6 266
13.Secondary Outcome
Title Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)
Hide Description MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.
Arm/Group Title Pregabalin DB Placebo
Hide Arm/Group Description:
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Overall Number of Participants Analyzed 147 147
Measure Type: Number
Unit of Measure: participants
67 60
14.Secondary Outcome
Title Weekly Mean Sleep Interference Score (Single-Blind Phase)
Hide Description Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1.
Time Frame SB Baseline, Week 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time point.
Arm/Group Title Pregabalin SB
Hide Arm/Group Description:
Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
Overall Number of Participants Analyzed 663
Mean (Standard Deviation)
Unit of Measure: units on a scale
SB Baseline (n= 663) 5.9  (2.09)
Week 1 (n= 657) 5.1  (2.22)
Week 2 (n= 636) 4.5  (2.29)
Week 3 (n= 614) 4.1  (2.30)
Week 4 (n= 589) 3.8  (2.30)
Week 5 (n= 566) 3.7  (2.29)
Week 6 (n= 548) 3.6  (2.35)
15.Secondary Outcome
Title Weekly Mean Sleep Interference Score (Double-Blind Phase)
Hide Description Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain).
Time Frame DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.
Arm/Group Title Pregabalin DB Placebo
Hide Arm/Group Description:
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Overall Number of Participants Analyzed 147 147
Mean (Standard Deviation)
Unit of Measure: units on a scale
DB Baseline (n= 147, 147) 2.5  (1.79) 2.3  (1.66)
Week 7 (n= 144, 145) 2.6  (1.92) 2.7  (1.99)
Week 8 (n= 143, 142) 2.6  (1.98) 3.0  (1.98)
Week 9 (n= 140, 134) 2.3  (1.88) 2.7  (1.94)
Week 10 (n= 138, 133) 2.3  (1.90) 2.7  (1.98)
Week 11 (n= 138, 128) 2.2  (1.81) 2.5  (1.78)
Week 12 (n= 136, 123) 2.3  (1.90) 2.4  (1.84)
Week 13 (n= 134, 122) 2.3  (1.87) 2.3  (1.78)
Week 14 (n= 133, 122) 2.3  (1.93) 2.3  (1.80)
Week 15 (n= 132, 120) 2.4  (1.93) 2.3  (1.80)
Week 16 (n= 132, 120) 2.3  (1.90) 2.3  (1.77)
Week 17 (n= 129, 116) 2.2  (1.88) 2.2  (1.85)
Week 18 (n= 128, 116) 2.3  (1.92) 2.3  (1.85)
Week 19 (n= 121, 111) 2.3  (2.05) 2.2  (1.80)
16.Secondary Outcome
Title Endpoint Mean Sleep Interference Score (Single-Blind Phase)
Hide Description Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Pregabalin SB
Hide Arm/Group Description:
Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
Overall Number of Participants Analyzed 658
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.8  (2.42)
17.Secondary Outcome
Title Endpoint Mean Sleep Interference Score (Double-Blind Phase)
Hide Description Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Pregabalin DB Placebo
Hide Arm/Group Description:
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Overall Number of Participants Analyzed 138 132
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.4  (2.10) 2.4  (2.05)
18.Secondary Outcome
Title Quality of Life Questionnaire– Diabetic Neuropathy (QOL-DN) (Single-Blind Phase)
Hide Description QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.
Time Frame SB Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time point.
Arm/Group Title Pregabalin SB
Hide Arm/Group Description:
Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
Overall Number of Participants Analyzed 665
Mean (Standard Deviation)
Unit of Measure: units on a scale
SB Baseline: Total QOL Scores (n= 665) 42.6  (22.22)
SB Baseline: Ph Fn/Large Fiber (n= 665) 23.9  (13.07)
SB Baseline: Activities of Daily Living (n= 665) 3.2  (3.69)
SB Baseline: Symptoms (n= 665) 10.8  (5.55)
SB Baseline: Small Fiber (n= 665) 3.4  (3.40)
SB Baseline: Autonomic (n= 665) 1.3  (1.74)
Week 6: Total QOL Scores (n= 618) 29.3  (21.76)
Week 6: Ph Fn/Large Fiber (n= 618) 15.8  (12.62)
Week 6: Activities of Daily Living (n= 618) 2.2  (3.08)
Week 6: Symptoms (n= 618) 7.8  (5.72)
Week 6: Small Fiber (n= 618) 2.3  (2.99)
Week 6: Autonomic (n= 618) 1.1  (1.69)
19.Secondary Outcome
Title Quality of Life Questionnaire– Diabetic Neuropathy (QOL-DN) (Double-Blind Phase)
Hide Description QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Pregabalin DB Placebo
Hide Arm/Group Description:
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Overall Number of Participants Analyzed 138 134
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total QOL Scores 21.9  (20.02) 24.1  (21.06)
Ph Fn/Large Fiber 11.4  (11.28) 12.9  (12.72)
Activities of Daily Living 1.8  (2.85) 1.8  (2.79)
Symptoms 6.1  (5.04) 6.6  (5.29)
Small Fiber 1.8  (3.38) 1.7  (2.50)
Autonomic 0.9  (1.55) 1.1  (1.53)
20.Secondary Outcome
Title Pain Visual Analog Scale (VAS) (Single-Blind Phase)
Hide Description Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.
Time Frame SB Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point.
Arm/Group Title Pregabalin SB
Hide Arm/Group Description:
Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
Overall Number of Participants Analyzed 665
Mean (Standard Deviation)
Unit of Measure: mm
SB Baseline (n= 665) 68.1  (13.79)
Week 6 (n= 621) 39.8  (23.19)
21.Secondary Outcome
Title Pain Visual Analog Scale (VAS) (Double-Blind Phase)
Hide Description Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Pregabalin DB Placebo
Hide Arm/Group Description:
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Overall Number of Participants Analyzed 138 134
Mean (Standard Deviation)
Unit of Measure: mm
25.3  (20.98) 30.1  (23.44)
22.Secondary Outcome
Title Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)
Hide Description BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).
Time Frame SB Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point.
Arm/Group Title Pregabalin SB
Hide Arm/Group Description:
Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
Overall Number of Participants Analyzed 665
Mean (Standard Deviation)
Unit of Measure: units on a scale
SB Baseline: Pain Severity (n= 665) 6.1  (1.45)
SB Baseline: Pain Interference (n= 665) 5.2  (2.09)
Week 6: Pain Severity (n= 637) 3.9  (2.13)
Week 6: Pain Interference (n= 637) 3.1  (2.31)
23.Secondary Outcome
Title Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase)
Hide Description BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Pregabalin DB Placebo
Hide Arm/Group Description:
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Overall Number of Participants Analyzed 140 136
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pain Severity 2.6  (1.85) 3.0  (2.03)
Pain Interference 2.0  (2.05) 2.4  (2.10)
24.Secondary Outcome
Title Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase)
Hide Description HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.
Time Frame SB Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “N” (number of participants) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time point.
Arm/Group Title Pregabalin SB
Hide Arm/Group Description:
Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
Overall Number of Participants Analyzed 663
Mean (Standard Deviation)
Unit of Measure: units on a scale
SB Baseline: HADS-A (n= 663) 5.8  (3.95)
SB Baseline: HADS-D (n= 663) 5.3  (3.70)
Week 6: HADS-A (n= 616) 4.6  (3.54)
Week 6: HADS-D (n= 616) 4.0  (3.52)
25.Secondary Outcome
Title Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase)
Hide Description HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Pregabalin DB Placebo
Hide Arm/Group Description:
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Overall Number of Participants Analyzed 138 134
Mean (Standard Deviation)
Unit of Measure: units on a scale
HADS-A 3.8  (2.94) 4.3  (3.56)
HADS-D 3.3  (3.12) 3.5  (3.28)
26.Secondary Outcome
Title Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase)
Hide Description GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered “how would you rate the study medication you received for pain?” on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Pregabalin SB
Hide Arm/Group Description:
Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
Overall Number of Participants Analyzed 621
Measure Type: Number
Unit of Measure: participants
Very Satisfied 241
Somewhat Satisfied 181
Slightly Satisfied 66
Neither Satisfied Nor Dissatisfied 71
Slightly Dissatisfied 22
Somewhat Dissatisfied 21
Very Dissatisfied 19
27.Secondary Outcome
Title Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)
Hide Description GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered “how would you rate the study medication you received for pain?” on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.
Time Frame Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title Pregabalin DB Placebo
Hide Arm/Group Description:
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
Overall Number of Participants Analyzed 138 134
Measure Type: Number
Unit of Measure: participants
Very Satisfied 80 64
Somewhat Satisfied 35 36
Slightly Satisfied 9 14
Neither Satisfied Nor Dissatisfied 6 10
Slightly Dissatisfied 5 2
Somewhat Dissatisfied 1 6
Very Dissatisfied 2 2
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Pregabalin SB Pregabalin DB Placebo
Hide Arm/Group Description Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
All-Cause Mortality
Pregabalin SB Pregabalin DB Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin SB Pregabalin DB Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/665 (2.56%)   11/147 (7.48%)   6/149 (4.03%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Cardiac disorders       
Acute coronary syndrome * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Angina pectoris * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Atrial fibrillation * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Bradycardia * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Coronary artery disease * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Myocardial infarction * 1  0/665 (0.00%)  2/147 (1.36%)  0/149 (0.00%) 
Eye disorders       
Vitreous haemorrhage * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Gastrointestinal disorders       
Rectal haemorrhage * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
General disorders       
Chest pain * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Generalised oedema * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Non-cardiac chest pain * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Oedema * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Infections and infestations       
Cellulitis * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Gangrene * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Osteomyelitis * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Pneumonia * 1  3/665 (0.45%)  1/147 (0.68%)  0/149 (0.00%) 
Sepsis * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Tracheitis * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Upper respiratory tract infection * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Urinary tract infection * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Urosepsis * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Injury, poisoning and procedural complications       
Burns first degree * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Femoral neck fracture * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Rib fracture * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Road traffic accident * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Soft tissue injury * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Investigations       
Blood pressure increased * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Metabolism and nutrition disorders       
Diabetes mellitus inadequate control * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Diabetic complication * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Hyperglycaemia * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Hypoglycaemia * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Ketoacidosis * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Nervous system disorders       
Cerebrovascular accident * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Presyncope * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Transient ischaemic attack * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Psychiatric disorders       
Depression * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Dyspnoea * 1  0/665 (0.00%)  1/147 (0.68%)  1/149 (0.67%) 
Respiratory failure * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregabalin SB Pregabalin DB Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   331/665 (49.77%)   86/147 (58.50%)   94/149 (63.09%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/665 (0.15%)  2/147 (1.36%)  1/149 (0.67%) 
Eosinophilia * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Leukocytosis * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Cardiac disorders       
Arrhythmia * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Cardiac failure * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Coronary artery disease * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Extrasystoles * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Palpitations * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Ear and labyrinth disorders       
Tinnitus * 1  3/665 (0.45%)  1/147 (0.68%)  1/149 (0.67%) 
Vertigo * 1  5/665 (0.75%)  0/147 (0.00%)  2/149 (1.34%) 
Eye disorders       
Cataract * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Conjunctivitis * 1  3/665 (0.45%)  1/147 (0.68%)  0/149 (0.00%) 
Cystoid macular oedema * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Diplopia * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Dry eye * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Eye haemorrhage * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Eye pain * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Periorbital oedema * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Retinal haemorrhage * 1  2/665 (0.30%)  1/147 (0.68%)  1/149 (0.67%) 
Retinal oedema * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Retinopathy hypertensive * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Vision blurred * 1  12/665 (1.80%)  0/147 (0.00%)  1/149 (0.67%) 
Visual impairment * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Vitreous disorder * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Vitreous haemorrhage * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort * 1  1/665 (0.15%)  1/147 (0.68%)  1/149 (0.67%) 
Abdominal distension * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Abdominal pain * 1  1/665 (0.15%)  1/147 (0.68%)  1/149 (0.67%) 
Abdominal pain upper * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Abdominal tenderness * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Constipation * 1  15/665 (2.26%)  2/147 (1.36%)  3/149 (2.01%) 
Dental caries * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Diarrhoea * 1  15/665 (2.26%)  5/147 (3.40%)  6/149 (4.03%) 
Dry mouth * 1  12/665 (1.80%)  5/147 (3.40%)  3/149 (2.01%) 
Dyspepsia * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Flatulence * 1  4/665 (0.60%)  0/147 (0.00%)  0/149 (0.00%) 
Frequent bowel movements * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Gastrooesophageal reflux disease * 1  2/665 (0.30%)  2/147 (1.36%)  0/149 (0.00%) 
Hypoaesthesia oral * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Impaired gastric emptying * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Irritable bowel syndrome * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Lip disorder * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Lip swelling * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Nausea * 1  22/665 (3.31%)  4/147 (2.72%)  5/149 (3.36%) 
Oesophageal spasm * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Toothache * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Vomiting * 1  5/665 (0.75%)  2/147 (1.36%)  4/149 (2.68%) 
General disorders       
Asthenia * 1  2/665 (0.30%)  2/147 (1.36%)  0/149 (0.00%) 
Breakthrough pain * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Chest pain * 1  4/665 (0.60%)  1/147 (0.68%)  0/149 (0.00%) 
Device breakage * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Face oedema * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Fatigue * 1  18/665 (2.71%)  3/147 (2.04%)  4/149 (2.68%) 
Feeling abnormal * 1  3/665 (0.45%)  0/147 (0.00%)  0/149 (0.00%) 
Feeling hot * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Feeling jittery * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Foaming at mouth * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Gait disturbance * 1  2/665 (0.30%)  1/147 (0.68%)  2/149 (1.34%) 
Generalised oedema * 1  2/665 (0.30%)  1/147 (0.68%)  1/149 (0.67%) 
Implant site pruritus * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Influenza like illness * 1  5/665 (0.75%)  1/147 (0.68%)  0/149 (0.00%) 
Irritability * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Local swelling * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Malaise * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Oedema * 1  10/665 (1.50%)  6/147 (4.08%)  5/149 (3.36%) 
Oedema peripheral * 1  53/665 (7.97%)  20/147 (13.61%)  16/149 (10.74%) 
Pain * 1  1/665 (0.15%)  2/147 (1.36%)  1/149 (0.67%) 
Pyrexia * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Thirst * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Immune system disorders       
Hypersensitivity * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Seasonal allergy * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Infections and infestations       
Acarodermatitis * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Acute sinusitis * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Body tinea * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Bronchitis * 1  3/665 (0.45%)  3/147 (2.04%)  0/149 (0.00%) 
Candidiasis * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Cellulitis * 1  5/665 (0.75%)  4/147 (2.72%)  0/149 (0.00%) 
Cystitis * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Ear infection * 1  2/665 (0.30%)  0/147 (0.00%)  1/149 (0.67%) 
Gastroenteritis * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Gastroenteritis viral * 1  3/665 (0.45%)  1/147 (0.68%)  1/149 (0.67%) 
Gastrointestinal viral infection * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Herpes zoster * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Hordeolum * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Influenza * 1  1/665 (0.15%)  3/147 (2.04%)  0/149 (0.00%) 
Localised infection * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Nasopharyngitis * 1  5/665 (0.75%)  4/147 (2.72%)  3/149 (2.01%) 
Oral herpes * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Pneumonia * 1  2/665 (0.30%)  0/147 (0.00%)  1/149 (0.67%) 
Postoperative wound infection * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Rhinitis * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Sinusitis * 1  4/665 (0.60%)  2/147 (1.36%)  3/149 (2.01%) 
Skin candida * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Staphylococcal infection * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Tinea pedis * 1  0/665 (0.00%)  0/147 (0.00%)  2/149 (1.34%) 
Tooth abscess * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Tooth infection * 1  3/665 (0.45%)  0/147 (0.00%)  1/149 (0.67%) 
Upper respiratory tract infection * 1  11/665 (1.65%)  7/147 (4.76%)  7/149 (4.70%) 
Urinary tract infection * 1  10/665 (1.50%)  3/147 (2.04%)  3/149 (2.01%) 
Viral upper respiratory tract infection * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Injury, poisoning and procedural complications       
Arthropod bite * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Burns second degree * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Contusion * 1  2/665 (0.30%)  1/147 (0.68%)  0/149 (0.00%) 
Ear canal injury * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Excoriation * 1  2/665 (0.30%)  1/147 (0.68%)  0/149 (0.00%) 
Fall * 1  3/665 (0.45%)  1/147 (0.68%)  1/149 (0.67%) 
Foot fracture * 1  2/665 (0.30%)  0/147 (0.00%)  1/149 (0.67%) 
Laceration * 1  3/665 (0.45%)  0/147 (0.00%)  0/149 (0.00%) 
Ligament sprain * 1  1/665 (0.15%)  1/147 (0.68%)  3/149 (2.01%) 
Limb injury * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Meniscus lesion * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Muscle strain * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Rib fracture * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Road traffic accident * 1  3/665 (0.45%)  1/147 (0.68%)  0/149 (0.00%) 
Skeletal injury * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Thermal burn * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Wound * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Investigations       
Blood amylase increased * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Blood creatine phosphokinase increased * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Blood creatinine increased * 1  0/665 (0.00%)  2/147 (1.36%)  2/149 (1.34%) 
Blood glucose increased * 1  0/665 (0.00%)  1/147 (0.68%)  1/149 (0.67%) 
Blood pressure diastolic abnormal * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Blood urea increased * 1  0/665 (0.00%)  2/147 (1.36%)  0/149 (0.00%) 
Blood uric acid increased * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Body temperature increased * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Breath sounds abnormal * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Cardiac murmur * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Haematocrit decreased * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Heart rate increased * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Hepatic enzyme increased * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Liver function test abnormal * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Platelet count decreased * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Urinary casts * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Urine analysis abnormal * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Weight increased * 1  11/665 (1.65%)  6/147 (4.08%)  3/149 (2.01%) 
Metabolism and nutrition disorders       
Dehydration * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Diabetes mellitus * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Diabetes mellitus inadequate control * 1  0/665 (0.00%)  0/147 (0.00%)  2/149 (1.34%) 
Fluid retention * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Gout * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Hyperglycaemia * 1  5/665 (0.75%)  1/147 (0.68%)  0/149 (0.00%) 
Hyperlipidaemia * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Hypoglycaemia * 1  2/665 (0.30%)  1/147 (0.68%)  0/149 (0.00%) 
Hypokalaemia * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Increased appetite * 1  5/665 (0.75%)  0/147 (0.00%)  2/149 (1.34%) 
Vitamin B12 deficiency * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Vitamin D deficiency * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  7/665 (1.05%)  3/147 (2.04%)  2/149 (1.34%) 
Arthropathy * 1  2/665 (0.30%)  2/147 (1.36%)  1/149 (0.67%) 
Back pain * 1  10/665 (1.50%)  2/147 (1.36%)  3/149 (2.01%) 
Exostosis * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Extremity contracture * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Joint stiffness * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Joint swelling * 1  1/665 (0.15%)  2/147 (1.36%)  0/149 (0.00%) 
Muscle spasms * 1  5/665 (0.75%)  2/147 (1.36%)  1/149 (0.67%) 
Muscle tightness * 1  2/665 (0.30%)  1/147 (0.68%)  0/149 (0.00%) 
Muscular weakness * 1  5/665 (0.75%)  3/147 (2.04%)  0/149 (0.00%) 
Musculoskeletal chest pain * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Musculoskeletal pain * 1  2/665 (0.30%)  0/147 (0.00%)  1/149 (0.67%) 
Musculoskeletal stiffness * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Myalgia * 1  3/665 (0.45%)  0/147 (0.00%)  1/149 (0.67%) 
Neck pain * 1  3/665 (0.45%)  1/147 (0.68%)  0/149 (0.00%) 
Osteoarthritis * 1  3/665 (0.45%)  2/147 (1.36%)  1/149 (0.67%) 
Pain in extremity * 1  19/665 (2.86%)  3/147 (2.04%)  8/149 (5.37%) 
Rhabdomyolysis * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Rotator cuff syndrome * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Spinal osteoarthritis * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Tendonitis * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Trigger finger * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Nervous system disorders       
Akathisia * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Allodynia * 1  3/665 (0.45%)  2/147 (1.36%)  2/149 (1.34%) 
Amnesia * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Areflexia * 1  2/665 (0.30%)  0/147 (0.00%)  1/149 (0.67%) 
Ataxia * 1  5/665 (0.75%)  0/147 (0.00%)  1/149 (0.67%) 
Balance disorder * 1  4/665 (0.60%)  0/147 (0.00%)  0/149 (0.00%) 
Burning sensation * 1  2/665 (0.30%)  0/147 (0.00%)  1/149 (0.67%) 
Carpal tunnel syndrome * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Cerebrovascular disorder * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Cognitive disorder * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Convulsion * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Coordination abnormal * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Decreased vibratory sense * 1  3/665 (0.45%)  0/147 (0.00%)  1/149 (0.67%) 
Depressed level of consciousness * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Diabetic neuropathy * 1  6/665 (0.90%)  1/147 (0.68%)  2/149 (1.34%) 
Disturbance in attention * 1  3/665 (0.45%)  0/147 (0.00%)  2/149 (1.34%) 
Dizziness * 1  45/665 (6.77%)  4/147 (2.72%)  2/149 (1.34%) 
Dizziness postural * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Dysgeusia * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Headache * 1  29/665 (4.36%)  4/147 (2.72%)  4/149 (2.68%) 
Hyperaesthesia * 1  3/665 (0.45%)  2/147 (1.36%)  4/149 (2.68%) 
Hypersomnia * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Hypoaesthesia * 1  7/665 (1.05%)  1/147 (0.68%)  2/149 (1.34%) 
Lethargy * 1  2/665 (0.30%)  1/147 (0.68%)  1/149 (0.67%) 
Memory impairment * 1  3/665 (0.45%)  0/147 (0.00%)  0/149 (0.00%) 
Migraine * 1  2/665 (0.30%)  0/147 (0.00%)  1/149 (0.67%) 
Neuralgia * 1  2/665 (0.30%)  0/147 (0.00%)  1/149 (0.67%) 
Neuropathy peripheral * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Paraesthesia * 1  3/665 (0.45%)  1/147 (0.68%)  1/149 (0.67%) 
Poor quality sleep * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Presyncope * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Sedation * 1  5/665 (0.75%)  0/147 (0.00%)  0/149 (0.00%) 
Sensory disturbance * 1  0/665 (0.00%)  0/147 (0.00%)  2/149 (1.34%) 
Sinus headache * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Somnolence * 1  38/665 (5.71%)  6/147 (4.08%)  5/149 (3.36%) 
Tension headache * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Tremor * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Psychiatric disorders       
Abnormal dreams * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Agitation * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Anorgasmia * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Anxiety * 1  3/665 (0.45%)  0/147 (0.00%)  0/149 (0.00%) 
Bradyphrenia * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Confusional state * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Depressed mood * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Depression * 1  6/665 (0.90%)  2/147 (1.36%)  2/149 (1.34%) 
Depressive symptom * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Disorientation * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Euphoric mood * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Hallucination, visual * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Insomnia * 1  11/665 (1.65%)  0/147 (0.00%)  2/149 (1.34%) 
Libido decreased * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Mood swings * 1  2/665 (0.30%)  1/147 (0.68%)  0/149 (0.00%) 
Nervousness * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Nightmare * 1  3/665 (0.45%)  1/147 (0.68%)  0/149 (0.00%) 
Post-traumatic stress disorder * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Sleep disorder * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Suicidal ideation * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Thinking abnormal * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Renal and urinary disorders       
Haematuria * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Nocturia * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Renal failure * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Renal failure acute * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Renal impairment * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Renal pain * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Urine odour abnormal * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Reproductive system and breast disorders       
Erectile dysfunction * 1  3/665 (0.45%)  0/147 (0.00%)  1/149 (0.67%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  3/665 (0.45%)  1/147 (0.68%)  1/149 (0.67%) 
Dyspnoea * 1  4/665 (0.60%)  1/147 (0.68%)  2/149 (1.34%) 
Dyspnoea exertional * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Increased upper airway secretion * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Nasal congestion * 1  2/665 (0.30%)  0/147 (0.00%)  0/149 (0.00%) 
Oropharyngeal pain * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Painful respiration * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Pharyngeal oedema * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Productive cough * 1  1/665 (0.15%)  0/147 (0.00%)  1/149 (0.67%) 
Respiratory tract congestion * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Rhinitis allergic * 1  0/665 (0.00%)  0/147 (0.00%)  2/149 (1.34%) 
Sinus congestion * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Sleep apnoea syndrome * 1  0/665 (0.00%)  2/147 (1.36%)  0/149 (0.00%) 
Snoring * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Skin and subcutaneous tissue disorders       
Acne * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Alopecia * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Blister * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Decubitus ulcer * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Dermal cyst * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Dry skin * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Eczema * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Heat rash * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Hyperhidrosis * 1  4/665 (0.60%)  1/147 (0.68%)  0/149 (0.00%) 
Hyperkeratosis * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Nail hypertrophy * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Pruritus * 1  3/665 (0.45%)  0/147 (0.00%)  2/149 (1.34%) 
Pruritus generalised * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Rash * 1  4/665 (0.60%)  1/147 (0.68%)  0/149 (0.00%) 
Rash macular * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Rash papular * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Rash pruritic * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Rosacea * 1  1/665 (0.15%)  0/147 (0.00%)  0/149 (0.00%) 
Skin discolouration * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Skin exfoliation * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Skin lesion * 1  1/665 (0.15%)  1/147 (0.68%)  0/149 (0.00%) 
Skin tightness * 1  0/665 (0.00%)  1/147 (0.68%)  0/149 (0.00%) 
Skin ulcer * 1  2/665 (0.30%)  2/147 (1.36%)  1/149 (0.67%) 
Swelling face * 1  2/665 (0.30%)  1/147 (0.68%)  0/149 (0.00%) 
Vascular disorders       
Hypertension * 1  2/665 (0.30%)  1/147 (0.68%)  0/149 (0.00%) 
Hypotension * 1  3/665 (0.45%)  1/147 (0.68%)  0/149 (0.00%) 
Intermittent claudication * 1  0/665 (0.00%)  0/147 (0.00%)  1/149 (0.67%) 
Peripheral vascular disorder * 1  0/665 (0.00%)  2/147 (1.36%)  0/149 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01057693     History of Changes
Other Study ID Numbers: A0081242
2009-017389-21 ( EudraCT Number )
First Submitted: January 26, 2010
First Posted: January 27, 2010
Results First Submitted: January 18, 2013
Results First Posted: February 22, 2013
Last Update Posted: February 20, 2019