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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01057693
Collaborator
(none)
633
172
2
22
3.7
0.2

Study Details

Study Description

Brief Summary

Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.

Condition or Disease Intervention/Treatment Phase
  • Drug: pregabalin (Lyrica)
  • Drug: Placebo
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
633 participants
Allocation:
Randomized
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A PHASE 3B MULTICENTER, DOUBLE-BLIND, RANDOMIZED WITHDRAWAL EFFICACY AND SAFETY STUDY OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH INADEQUATELY TREATED PAINFUL DIABETIC PERIPHERAL NEUROPATHY
Actual Study Start Date :
Mar 31, 2010
Actual Primary Completion Date :
Jan 30, 2012
Actual Study Completion Date :
Jan 30, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: pregabalin (Lyrica)

Drug: pregabalin (Lyrica)
Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.

Placebo Comparator: Placebo

Drug: Placebo
Placebo is supplied as capsules and given 3 times daily.

Outcome Measures

Primary Outcome Measures

  1. Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase [SB Baseline, Week 19 (DB Phase)]

    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.

Secondary Outcome Measures

  1. Time to Loss of Pain Response (Double-Blind Phase) [SB Baseline up to Week 19]

    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.

  2. Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase [SB Baseline, Week 6 (SB Phase)]

    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.

  3. Weekly Mean Pain Scores (Single-Blind Phase) [Week 1, 2, 3, 4, 5, 6]

    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.

  4. Weekly Mean Pain Scores (Double-Blind Phase) [DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19]

    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.

  5. Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase) [Week 6]

    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.

  6. Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase) [Week 19]

    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.

  7. Patient Global Impression of Change (PGIC) (Single-Blind Phase) [Week 6]

    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.

  8. Patient Global Impression of Change (PGIC) (Double-Blind Phase) [Week 19]

    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.

  9. Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) [SB Baseline, Week 6]

    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.

  10. Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) [Week 19]

    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.

  11. Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase) [SB Baseline, Week 6]

    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.

  12. Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase) [Week 19]

    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.

  13. Weekly Mean Sleep Interference Score (Single-Blind Phase) [SB Baseline, Week 1, 2, 3, 4, 5, 6]

    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.

  14. Weekly Mean Sleep Interference Score (Double-Blind Phase) [DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19]

    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).

  15. Endpoint Mean Sleep Interference Score (Single-Blind Phase) [Week 6]

    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).

  16. Endpoint Mean Sleep Interference Score (Double-Blind Phase) [Week 19]

    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).

  17. Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) [SB Baseline, Week 6]

    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.

  18. Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) [Week 19]

    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.

  19. Pain Visual Analog Scale (VAS) (Single-Blind Phase) [SB Baseline, Week 6]

    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.

  20. Pain Visual Analog Scale (VAS) (Double-Blind Phase) [Week 19]

    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.

  21. Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase) [SB Baseline, Week 6]

    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).

  22. Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase) [Week 19]

    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).

  23. Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase) [SB Baseline, Week 6]

    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.

  24. Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase) [Week 19]

    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.

  25. Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) [Week 6]

    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.

  26. Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) [Week 19]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.
Exclusion Criteria:
  • Patients with other pain conditions cannot participate.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Greystone Medical Research, LLC Birmingham Alabama United States 35242
2 Neurology Clinic, PC Northport Alabama United States 35476
3 Horizon Clinical Research Associates, PLLC Gilbert Arizona United States 85295
4 Dedicated Clinical Research, Inc. Goodyear Arizona United States 85395
5 Dedicated Clinical Research Goodyear Arizona United States 85395
6 Novara Clinical Research Mesa Arizona United States 85206
7 Arizona Research Center Phoenix Arizona United States 85023
8 Radiant Research, Inc. Scottsdale Arizona United States 85251
9 Genova Clinical Research, Inc. Tucson Arizona United States 85704
10 Central Arkansas Research Hot Springs Arkansas United States 71913
11 Little Rock Diagnostic Clinic Little Rock Arkansas United States 72205
12 Convergys Clinical Research, Inc. Anaheim California United States 92805
13 Providence Clinical Research Burbank California United States 91505
14 Valley Research Fresno California United States 93720
15 Center for United Research, Inc. Lakewood California United States 90712
16 Healthcare Partners Medical Group Los Angeles California United States 90015
17 University of Southern California, Keck School of Medicine, Department of Neurology Los Angeles California United States 90033
18 Richard S. Cherlin, MD Los Gatos California United States 95032
19 Northridge Neurological Research Northridge California United States 91325
20 Remek Research Pomona California United States 91767
21 Sierra Clinical Research Roseville California United States 95661
22 CNRI-San Diego, LLC San Diego California United States 92102
23 San Diego Clinical Trials San Diego California United States 92120
24 Center for Clinical Research, Inc. San Francisco California United States 94115
25 Apex Research Institute Santa Ana California United States 92705
26 Neurological Research Institute Santa Monica California United States 90404
27 Diablo Clinical Research, Inc. Walnut Creek California United States 94598
28 Foothills Pain Management West Covina California United States 91790
29 Aurora Family Medicine Center, PC Aurora Colorado United States 80012
30 Alpine Clinical Research Center, Inc. Boulder Colorado United States 80304
31 Mountain View Clinical Research Denver Colorado United States 80209
32 Chase Medical Research, LLC Waterbury Connecticut United States 06708
33 Metabolic Research Institute, Inc. Boynton Beach Florida United States 33472
34 Bradenton Research Center Bradenton Florida United States 34205
35 Meridien Research Bradenton Florida United States 34208
36 Meridien Research Brooksville Florida United States 34601
37 Innovative Research of West Florida, Inc. Clearwater Florida United States 33756
38 Clinical Research of West Florida, Inc. Clearwater Florida United States 33765
39 Deerfield Beach Cardiology Research Deerfield Beach Florida United States 33442
40 Gulfcoast Clinical Research Center Fort Myers Florida United States 33912
41 MD Clinical Hallandale Beach Florida United States 33009
42 Elite Research Institute Miami Florida United States 33169
43 Suncoast Clinical Research, Inc. New Port Richey Florida United States 34652
44 Laszlo J. Mate, MD North Palm Beach Florida United States 33408
45 Family Care Specialists, Inc. Ocala Florida United States 34471
46 Renstar Medical Research Ocala Florida United States 34471
47 Compass Research, LLC Orlando Florida United States 32806
48 Palm Beach Neurological Center, Advanced Research Consultants, Inc. Palm Beach Gardens Florida United States 33418
49 Suncoast Clinical Research Palm Harbor Florida United States 34684
50 Meridien Research Saint Petersburg Florida United States 33709
51 Neurology Clinical Research, Inc. Sunrise Florida United States 33351
52 Clinical Research of West Florida, Inc. Tampa Florida United States 33603
53 Meridien Research Tampa Florida United States 33606
54 Clinical Research of Central Florida Winter Haven Florida United States 33880
55 NeuroTrials Research, Incorporated Atlanta Georgia United States 30342
56 CPM Research Institute Austell Georgia United States 30106
57 Columbus Research Foundation Columbus Georgia United States 31904
58 Rockdale Medical Research Associates Conyers Georgia United States 30094
59 Prism Research Group Rome Georgia United States 30165
60 Valley Health Care Rome Georgia United States 30165
61 East-West Medical Research Institute Honolulu Hawaii United States 96814
62 Advanced Clinical Research Meridian Idaho United States 83642
63 AMR Sakeena Research Aurora Illinois United States 60504
64 Chicago Research Center, Inc. Chicago Illinois United States 60634
65 American Medical Research, Inc. Oak Brook Illinois United States 60523
66 MediSphere Medical Research Center, LLC Evansville Indiana United States 47714
67 American Health Network Greenfield Indiana United States 46140
68 Rehabilitation Associates of Indiana Indianapolis Indiana United States 46250
69 University of Kansas Medical Center Kansas City Kansas United States 66160
70 Heartland Research Associates, LLC Wichita Kansas United States 67207
71 Kentucky Medical Research Center Lexington Kentucky United States 40504
72 Endocrinology Center of Southwest Louisiana Lake Charles Louisiana United States 70601
73 Heartland Research, LLC Lake Charles Louisiana United States 70601
74 Primary Physician Care, LLC Lake Charles Louisiana United States 70601
75 Arthritis and Diabetes Clinic, Inc Monroe Louisiana United States 71203
76 Miray Medical Center Brockton Massachusetts United States 02301
77 Clinical Research Center of Cape Cod, Inc. Hyannis Massachusetts United States 02601
78 MedVadis Research Corporation Watertown Massachusetts United States 02472
79 Clinical Pharmacology Study Group Worcester Massachusetts United States 01605
80 Michigan Head Pain and Neurological Institute Ann Arbor Michigan United States 48104
81 Harris and Associates MD, PC Detroit Michigan United States 48235
82 Borgess Diabetes Center Kalamazoo Michigan United States 49048
83 Borgess Research Institute Kalamazoo Michigan United States 49048
84 William Beaumont Hospital Royal Oak Michigan United States 48073
85 KMED Research Saint Clair Shores Michigan United States 48081
86 William Beaumont Hospital Troy Michigan United States 48085
87 Troy Internal Medicine, PC Troy Michigan United States 48098
88 MAPS Applied Research Center, Inc. Edina Minnesota United States 55435
89 Medical Advanced Pain Specialists (MAPS) Edina Minnesota United States 55435
90 Medical Advanced Pain Specialists Maple Grove Minnesota United States 55369
91 Medical Advanced Pain Specialists Shakopee Minnesota United States 55379
92 CRC of Jackson Jackson Mississippi United States 39202
93 Physician's Surgery Center Jackson Mississippi United States 39202
94 Randall T. Huling, Jr., MD, CPI Olive Branch Mississippi United States 38654
95 University of Missouri Healthcare/Cosmopolitan Diabetes and Endocrinology Center Columbia Missouri United States 65212
96 Melinda A. Crockett-Maples Marionville Missouri United States 65705
97 A & A Pain Institute of Saint Louis Saint Louis Missouri United States 63141
98 Mercy Health Research Saint Louis Missouri United States 63141
99 Clinvest Springfield Missouri United States 65807
100 Lincoln Internal Medicine Associates Lincoln Nebraska United States 68516
101 Desert Endocrinology Clinical Research Center Henderson Nevada United States 89052
102 Desert Endocrinology Las Vegas Nevada United States 89117
103 Office of Dr. Danka Michaels, MD Las Vegas Nevada United States 89128
104 Office of Stephen Miller, M.D. Las Vegas Nevada United States 89144
105 Raleigh Neurology Associates, P.A. Raleigh North Carolina United States 27607-6520
106 Carolina Pharmaceutical Research Statesville North Carolina United States 28625
107 Radiant Research, Inc. Akron Ohio United States 44311
108 Community Research Cincinnati Ohio United States 45245
109 Radiant Research Cincinnati Ohio United States 45249
110 Hometown Urgent Care and Research Dayton Ohio United States 45432
111 Providence Health Partners - Center for Clinical Research Dayton Ohio United States 45439
112 Sooner Clinical Research Oklahoma City Oklahoma United States 73112
113 Veronique Sebastian, MD Oklahoma City Oklahoma United States 73120
114 Angelique Barreto, MD Oklahoma City Oklahoma United States 73134
115 Oregon Health & Science University Portland Oregon United States 97239-3098
116 Blair Orthopedic Associates, Inc. Altoona Pennsylvania United States 16602
117 Altoona Center for Clinical Research Duncansville Pennsylvania United States 16635
118 Research Protocol Management Specialists Pittsburgh Pennsylvania United States 15243
119 Coastal Medical East Greenwich Rhode Island United States 02818
120 Memorial Hospital of Rhode Island Pawtucket Rhode Island United States 02860
121 Omega Medical Research Warwick Rhode Island United States 02886
122 Aiken Center for Clinical Research Aiken South Carolina United States 29801
123 TLM Medical Services, LLC Columbia South Carolina United States 29204
124 Radiant Research Inc. Greer South Carolina United States 29651
125 Neurology and Pain Clinic, LLC Orangeburg South Carolina United States 29118
126 University Diabetes & Endocrine Consultants Chattanooga Tennessee United States 37403
127 SCRI Research Center Germantown Tennessee United States 38138
128 Sarah Cannon Research Institute Jackson Tennessee United States 38305
129 AM Diabetes & Endocrinology Center Memphis Tennessee United States 38133
130 Memphis Internal Medicine Memphis Tennessee United States 38138
131 ClinRx Research LLC Carrollton Texas United States 75007
132 Baylor University Medical Center Dallas Texas United States 75246
133 University of Texas Southwestern Medical Center at Dallas Dallas Texas United States 75390-8858
134 Medical Group of Texas Fort Worth Texas United States 76104
135 The Nerve and Muscle Center of Texas Houston Texas United States 77030
136 ClinRx Research, LLC Richardson Texas United States 75080
137 Paragon Research Center, LLC San Antonio Texas United States 78205
138 Alamo Clinical Research San Antonio Texas United States 78212
139 Cetero Research - San Antonio San Antonio Texas United States 78229
140 Pioneer Research Solutions, Inc Sugar Land Texas United States 77479
141 L. Craig Larsen and Clark C. Larsen Murray Utah United States 84107
142 Aspen Clinical Research Orem Utah United States 84058
143 Daniel B. Vine, MD Salt Lake City Utah United States 84107
144 Wasatch Clinical Research Salt Lake City Utah United States 84107
145 Jean Brown Research Salt Lake City Utah United States 84124
146 Foot and Ankle Clinic West Jordan Utah United States 84088
147 Neurological Associates, Incorporated Henrico Virginia United States 23226
148 National Clinical Research - Norfolk, Inc. Norfolk Virginia United States 23502
149 Spokane Internal Medicine Spokane Washington United States 99216
150 Aurora Advanced Healthcare, Inc. Milwaukee Wisconsin United States 53209
151 University of Calgary Calgary Alberta Canada T2N4Z6
152 Winnipeg Health Sciences Centre Winnipeg Manitoba Canada R3A 1R9
153 Winnipeg Regional Health Authority Sciences Centre Winnipeg Winnipeg Manitoba Canada R3E 3P4
154 Capital District Health Authority, QEII Health Sciences Centre Halifax Nova Scotia Canada B3H 1V7
155 Capital District Health Authority, QEII Health Sciences Centre Halifax Nova Scotia Canada B3H 2Y9
156 The Ottawa Hospital, Riverside Campus - Riverside Professional Building Ottawa Ontario Canada K1H 1A2
157 Toronto General Hospital Toronto Ontario Canada M5G 2C4
158 Ponce School of Medicine & Health Sciences Ponce Puerto Rico 00716
159 Instituto de Endocrinologia Diabetes y Metabolismo Toa Baja Puerto Rico 00949
160 Bloemfontein Medi-Clinic Bloemfontein FREE State South Africa 9301
161 Dr Makan's Rooms Johannesburg Gauteng South Africa 1827
162 Chris Hani Baragwanath Hospital Soweto Gauteng South Africa 2013
163 Randles Road Medical Centre Durban Kwa-zulu Natal South Africa 4000
164 Chelmsford Medical Centre Durban Kwazulu Natal South Africa 4001
165 Centre for Diabetes and Endocrinology Durban Kwazulu Natal South Africa 4091
166 Parklands Medical Centre Overport Kwazulu Natal South Africa 4091
167 Dr Jeevren Reddy's Surgery Stanger Kwazulu Natal South Africa 4450
168 Dot Shuttleworth Centre for Diabetes Durban Overport South Africa 4091
169 Centre for Diabetes and Endocrinology Houghton, Johannesburg South Africa 2198
170 102 Parklands Medical Centre Overport, Durban South Africa 4001
171 Dr's Sauermann and Meyer Polokwane South Africa
172 Diabetes Care Centre Pretoria South Africa 0001

Sponsors and Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT01057693
Other Study ID Numbers:
  • A0081242
  • 2009-017389-21
First Posted:
Jan 27, 2010
Last Update Posted:
Jan 20, 2021
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Pregabalin SB Pregabalin DB Placebo
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
Period Title: Single-Blind Phase (Up to Week 6)
STARTED 566 0 0
COMPLETED 296 0 0
NOT COMPLETED 270 0 0
Period Title: Single-Blind Phase (Up to Week 6)
STARTED 0 147 149
Treated 0 147 147
COMPLETED 0 125 113
NOT COMPLETED 0 22 36

Baseline Characteristics

Arm/Group Title Pregabalin SB
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 Participants 665
Age, Customized (participants) [Number]
18 to 44 Years
58
8.7%
45 to 64 Years
417
62.7%
>=65 Years
190
28.6%
Sex: Female, Male (Count of Participants)
Female
302
45.4%
Male
363
54.6%

Outcome Measures

1. Primary Outcome
Title Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase
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)

Outcome Measure Data

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
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.
Measure Participants 147 147
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)
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.1221
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.74 to 0.09
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Time to Loss of Pain Response (Double-Blind Phase)
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

Outcome Measure Data

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
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.
Measure Participants 147 147
Median (95% Confidence Interval) [days]
NA
NA
3. Secondary Outcome
Title Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase
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)

Outcome Measure Data

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
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.
Measure Participants 663
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)
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

Outcome Measure Data

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
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.
Measure Participants 657
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)
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

Outcome Measure Data

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
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.
Measure Participants 147 147
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)
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

Outcome Measure Data

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
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.
Measure Participants 665
>=30 % Reduction
49.92
7.5%
>=50 % Reduction
27.22
4.1%
7. Secondary Outcome
Title Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)
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

Outcome Measure Data

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
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.
Measure Participants 147 147
>=30% Reduction
82.99
12.5%
79.19
NaN
>=50% Reduction
62.59
9.4%
55.03
NaN
8. Secondary Outcome
Title Patient Global Impression of Change (PGIC) (Single-Blind Phase)
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

Outcome Measure Data

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
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.
Measure Participants 620
Very Much Improved
93
14%
Much Improved
221
33.2%
Minimally Improved
194
29.2%
No Change
65
9.8%
Minimally Worse
29
4.4%
Much Worse
15
2.3%
Very Much Worse
3
0.5%
9. Secondary Outcome
Title Patient Global Impression of Change (PGIC) (Double-Blind Phase)
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

Outcome Measure Data

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
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.
Measure Participants 138 134
Very Much Improved
23
3.5%
23
NaN
Much Improved
50
7.5%
46
NaN
Minimally Improved
27
4.1%
28
NaN
No Change
28
4.2%
20
NaN
Minimally Worse
9
1.4%
6
NaN
Much Worse
1
0.2%
8
NaN
Very Much Worse
0
0%
3
NaN
10. Secondary Outcome
Title Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)
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

Outcome Measure Data

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
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.
Measure Participants 665
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)
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

Outcome Measure Data

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
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.
Measure Participants 138 134
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)
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

Outcome Measure Data

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
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.
Measure Participants 665
SB Baseline
180
27.1%
Week 6
266
40%
13. Secondary Outcome
Title Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)
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

Outcome Measure Data

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
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.
Measure Participants 147 147
Number [participants]
67
10.1%
60
NaN
14. Secondary Outcome
Title Weekly Mean Sleep Interference Score (Single-Blind Phase)
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

Outcome Measure Data

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
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.
Measure Participants 663
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)
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

Outcome Measure Data

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
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.
Measure Participants 147 147
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)
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

Outcome Measure Data

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
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.
Measure Participants 658
Mean (Standard Deviation) [units on a scale]
3.8
(2.42)
17. Secondary Outcome
Title Endpoint Mean Sleep Interference Score (Double-Blind Phase)
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

Outcome Measure Data

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
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.
Measure Participants 138 132
Mean (Standard Deviation) [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)
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

Outcome Measure Data

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
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.
Measure Participants 665
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)
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

Outcome Measure Data

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
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.
Measure Participants 138 134
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)
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

Outcome Measure Data

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
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.
Measure Participants 665
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)
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

Outcome Measure Data

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
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.
Measure Participants 138 134
Mean (Standard Deviation) [mm]
25.3
(20.98)
30.1
(23.44)
22. Secondary Outcome
Title Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)
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

Outcome Measure Data

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
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.
Measure Participants 665
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)
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

Outcome Measure Data

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
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.
Measure Participants 140 136
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)
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

Outcome Measure Data

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
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.
Measure Participants 663
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)
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

Outcome Measure Data

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
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.
Measure Participants 138 134
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)
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

Outcome Measure Data

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
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.
Measure Participants 621
Very Satisfied
241
36.2%
Somewhat Satisfied
181
27.2%
Slightly Satisfied
66
9.9%
Neither Satisfied Nor Dissatisfied
71
10.7%
Slightly Dissatisfied
22
3.3%
Somewhat Dissatisfied
21
3.2%
Very Dissatisfied
19
2.9%
27. Secondary Outcome
Title Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)
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

Outcome Measure Data

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
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.
Measure Participants 138 134
Very Satisfied
80
12%
64
NaN
Somewhat Satisfied
35
5.3%
36
NaN
Slightly Satisfied
9
1.4%
14
NaN
Neither Satisfied Nor Dissatisfied
6
0.9%
10
NaN
Slightly Dissatisfied
5
0.8%
2
NaN
Somewhat Dissatisfied
1
0.2%
6
NaN
Very Dissatisfied
2
0.3%
2
NaN

Adverse Events

Time Frame
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
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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Pregabalin SB Pregabalin DB Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 17/665 (2.6%) 11/147 (7.5%) 6/149 (4%)
Blood and lymphatic system disorders
Anaemia 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Cardiac disorders
Acute coronary syndrome 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Angina pectoris 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Atrial fibrillation 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Bradycardia 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Coronary artery disease 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Myocardial infarction 0/665 (0%) 2/147 (1.4%) 0/149 (0%)
Eye disorders
Vitreous haemorrhage 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Gastrointestinal disorders
Rectal haemorrhage 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
General disorders
Chest pain 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Generalised oedema 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Non-cardiac chest pain 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Oedema 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Hepatobiliary disorders
Cholelithiasis 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Infections and infestations
Cellulitis 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Gangrene 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Osteomyelitis 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Pneumonia 3/665 (0.5%) 1/147 (0.7%) 0/149 (0%)
Sepsis 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Tracheitis 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Upper respiratory tract infection 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Urinary tract infection 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Urosepsis 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Injury, poisoning and procedural complications
Burns first degree 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Femoral neck fracture 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Rib fracture 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Road traffic accident 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Soft tissue injury 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Investigations
Blood pressure increased 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Metabolism and nutrition disorders
Diabetes mellitus inadequate control 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Diabetic complication 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Hyperglycaemia 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Hypoglycaemia 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Ketoacidosis 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Nervous system disorders
Cerebrovascular accident 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Presyncope 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Transient ischaemic attack 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Psychiatric disorders
Depression 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Dyspnoea 0/665 (0%) 1/147 (0.7%) 1/149 (0.7%)
Respiratory failure 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Other (Not Including Serious) Adverse Events
Pregabalin SB Pregabalin DB Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 331/665 (49.8%) 86/147 (58.5%) 94/149 (63.1%)
Blood and lymphatic system disorders
Anaemia 1/665 (0.2%) 2/147 (1.4%) 1/149 (0.7%)
Eosinophilia 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Leukocytosis 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Cardiac disorders
Arrhythmia 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Cardiac failure 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Coronary artery disease 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Extrasystoles 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Palpitations 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Ear and labyrinth disorders
Tinnitus 3/665 (0.5%) 1/147 (0.7%) 1/149 (0.7%)
Vertigo 5/665 (0.8%) 0/147 (0%) 2/149 (1.3%)
Eye disorders
Cataract 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Conjunctivitis 3/665 (0.5%) 1/147 (0.7%) 0/149 (0%)
Cystoid macular oedema 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Diplopia 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Dry eye 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Eye haemorrhage 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Eye pain 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Periorbital oedema 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Retinal haemorrhage 2/665 (0.3%) 1/147 (0.7%) 1/149 (0.7%)
Retinal oedema 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Retinopathy hypertensive 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Vision blurred 12/665 (1.8%) 0/147 (0%) 1/149 (0.7%)
Visual impairment 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Vitreous disorder 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Vitreous haemorrhage 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Gastrointestinal disorders
Abdominal discomfort 1/665 (0.2%) 1/147 (0.7%) 1/149 (0.7%)
Abdominal distension 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Abdominal pain 1/665 (0.2%) 1/147 (0.7%) 1/149 (0.7%)
Abdominal pain upper 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Abdominal tenderness 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Constipation 15/665 (2.3%) 2/147 (1.4%) 3/149 (2%)
Dental caries 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Diarrhoea 15/665 (2.3%) 5/147 (3.4%) 6/149 (4%)
Dry mouth 12/665 (1.8%) 5/147 (3.4%) 3/149 (2%)
Dyspepsia 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Flatulence 4/665 (0.6%) 0/147 (0%) 0/149 (0%)
Frequent bowel movements 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Gastrooesophageal reflux disease 2/665 (0.3%) 2/147 (1.4%) 0/149 (0%)
Hypoaesthesia oral 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Impaired gastric emptying 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Irritable bowel syndrome 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Lip disorder 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Lip swelling 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Nausea 22/665 (3.3%) 4/147 (2.7%) 5/149 (3.4%)
Oesophageal spasm 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Toothache 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Vomiting 5/665 (0.8%) 2/147 (1.4%) 4/149 (2.7%)
General disorders
Asthenia 2/665 (0.3%) 2/147 (1.4%) 0/149 (0%)
Breakthrough pain 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Chest pain 4/665 (0.6%) 1/147 (0.7%) 0/149 (0%)
Device breakage 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Face oedema 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Fatigue 18/665 (2.7%) 3/147 (2%) 4/149 (2.7%)
Feeling abnormal 3/665 (0.5%) 0/147 (0%) 0/149 (0%)
Feeling hot 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Feeling jittery 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Foaming at mouth 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Gait disturbance 2/665 (0.3%) 1/147 (0.7%) 2/149 (1.3%)
Generalised oedema 2/665 (0.3%) 1/147 (0.7%) 1/149 (0.7%)
Implant site pruritus 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Influenza like illness 5/665 (0.8%) 1/147 (0.7%) 0/149 (0%)
Irritability 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Local swelling 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Malaise 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Oedema 10/665 (1.5%) 6/147 (4.1%) 5/149 (3.4%)
Oedema peripheral 53/665 (8%) 20/147 (13.6%) 16/149 (10.7%)
Pain 1/665 (0.2%) 2/147 (1.4%) 1/149 (0.7%)
Pyrexia 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Thirst 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Immune system disorders
Hypersensitivity 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Seasonal allergy 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Infections and infestations
Acarodermatitis 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Acute sinusitis 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Body tinea 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Bronchitis 3/665 (0.5%) 3/147 (2%) 0/149 (0%)
Candidiasis 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Cellulitis 5/665 (0.8%) 4/147 (2.7%) 0/149 (0%)
Cystitis 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Ear infection 2/665 (0.3%) 0/147 (0%) 1/149 (0.7%)
Gastroenteritis 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Gastroenteritis viral 3/665 (0.5%) 1/147 (0.7%) 1/149 (0.7%)
Gastrointestinal viral infection 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Herpes zoster 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Hordeolum 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Influenza 1/665 (0.2%) 3/147 (2%) 0/149 (0%)
Localised infection 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Nasopharyngitis 5/665 (0.8%) 4/147 (2.7%) 3/149 (2%)
Oral herpes 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Pneumonia 2/665 (0.3%) 0/147 (0%) 1/149 (0.7%)
Postoperative wound infection 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Rhinitis 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Sinusitis 4/665 (0.6%) 2/147 (1.4%) 3/149 (2%)
Skin candida 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Staphylococcal infection 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Tinea pedis 0/665 (0%) 0/147 (0%) 2/149 (1.3%)
Tooth abscess 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Tooth infection 3/665 (0.5%) 0/147 (0%) 1/149 (0.7%)
Upper respiratory tract infection 11/665 (1.7%) 7/147 (4.8%) 7/149 (4.7%)
Urinary tract infection 10/665 (1.5%) 3/147 (2%) 3/149 (2%)
Viral upper respiratory tract infection 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Injury, poisoning and procedural complications
Arthropod bite 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Burns second degree 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Contusion 2/665 (0.3%) 1/147 (0.7%) 0/149 (0%)
Ear canal injury 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Excoriation 2/665 (0.3%) 1/147 (0.7%) 0/149 (0%)
Fall 3/665 (0.5%) 1/147 (0.7%) 1/149 (0.7%)
Foot fracture 2/665 (0.3%) 0/147 (0%) 1/149 (0.7%)
Laceration 3/665 (0.5%) 0/147 (0%) 0/149 (0%)
Ligament sprain 1/665 (0.2%) 1/147 (0.7%) 3/149 (2%)
Limb injury 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Meniscus lesion 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Muscle strain 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Rib fracture 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Road traffic accident 3/665 (0.5%) 1/147 (0.7%) 0/149 (0%)
Skeletal injury 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Thermal burn 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Wound 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Investigations
Blood amylase increased 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Blood creatine phosphokinase increased 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Blood creatinine increased 0/665 (0%) 2/147 (1.4%) 2/149 (1.3%)
Blood glucose increased 0/665 (0%) 1/147 (0.7%) 1/149 (0.7%)
Blood pressure diastolic abnormal 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Blood urea increased 0/665 (0%) 2/147 (1.4%) 0/149 (0%)
Blood uric acid increased 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Body temperature increased 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Breath sounds abnormal 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Cardiac murmur 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Haematocrit decreased 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Heart rate increased 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Hepatic enzyme increased 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Liver function test abnormal 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Platelet count decreased 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Urinary casts 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Urine analysis abnormal 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Weight increased 11/665 (1.7%) 6/147 (4.1%) 3/149 (2%)
Metabolism and nutrition disorders
Dehydration 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Diabetes mellitus 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Diabetes mellitus inadequate control 0/665 (0%) 0/147 (0%) 2/149 (1.3%)
Fluid retention 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Gout 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Hyperglycaemia 5/665 (0.8%) 1/147 (0.7%) 0/149 (0%)
Hyperlipidaemia 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Hypoglycaemia 2/665 (0.3%) 1/147 (0.7%) 0/149 (0%)
Hypokalaemia 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Increased appetite 5/665 (0.8%) 0/147 (0%) 2/149 (1.3%)
Vitamin B12 deficiency 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Vitamin D deficiency 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 7/665 (1.1%) 3/147 (2%) 2/149 (1.3%)
Arthropathy 2/665 (0.3%) 2/147 (1.4%) 1/149 (0.7%)
Back pain 10/665 (1.5%) 2/147 (1.4%) 3/149 (2%)
Exostosis 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Extremity contracture 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Joint stiffness 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Joint swelling 1/665 (0.2%) 2/147 (1.4%) 0/149 (0%)
Muscle spasms 5/665 (0.8%) 2/147 (1.4%) 1/149 (0.7%)
Muscle tightness 2/665 (0.3%) 1/147 (0.7%) 0/149 (0%)
Muscular weakness 5/665 (0.8%) 3/147 (2%) 0/149 (0%)
Musculoskeletal chest pain 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Musculoskeletal pain 2/665 (0.3%) 0/147 (0%) 1/149 (0.7%)
Musculoskeletal stiffness 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Myalgia 3/665 (0.5%) 0/147 (0%) 1/149 (0.7%)
Neck pain 3/665 (0.5%) 1/147 (0.7%) 0/149 (0%)
Osteoarthritis 3/665 (0.5%) 2/147 (1.4%) 1/149 (0.7%)
Pain in extremity 19/665 (2.9%) 3/147 (2%) 8/149 (5.4%)
Rhabdomyolysis 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Rotator cuff syndrome 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Spinal osteoarthritis 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Tendonitis 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Trigger finger 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Nervous system disorders
Akathisia 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Allodynia 3/665 (0.5%) 2/147 (1.4%) 2/149 (1.3%)
Amnesia 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Areflexia 2/665 (0.3%) 0/147 (0%) 1/149 (0.7%)
Ataxia 5/665 (0.8%) 0/147 (0%) 1/149 (0.7%)
Balance disorder 4/665 (0.6%) 0/147 (0%) 0/149 (0%)
Burning sensation 2/665 (0.3%) 0/147 (0%) 1/149 (0.7%)
Carpal tunnel syndrome 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Cerebrovascular disorder 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Cognitive disorder 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Convulsion 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Coordination abnormal 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Decreased vibratory sense 3/665 (0.5%) 0/147 (0%) 1/149 (0.7%)
Depressed level of consciousness 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Diabetic neuropathy 6/665 (0.9%) 1/147 (0.7%) 2/149 (1.3%)
Disturbance in attention 3/665 (0.5%) 0/147 (0%) 2/149 (1.3%)
Dizziness 45/665 (6.8%) 4/147 (2.7%) 2/149 (1.3%)
Dizziness postural 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Dysgeusia 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Headache 29/665 (4.4%) 4/147 (2.7%) 4/149 (2.7%)
Hyperaesthesia 3/665 (0.5%) 2/147 (1.4%) 4/149 (2.7%)
Hypersomnia 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Hypoaesthesia 7/665 (1.1%) 1/147 (0.7%) 2/149 (1.3%)
Lethargy 2/665 (0.3%) 1/147 (0.7%) 1/149 (0.7%)
Memory impairment 3/665 (0.5%) 0/147 (0%) 0/149 (0%)
Migraine 2/665 (0.3%) 0/147 (0%) 1/149 (0.7%)
Neuralgia 2/665 (0.3%) 0/147 (0%) 1/149 (0.7%)
Neuropathy peripheral 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Paraesthesia 3/665 (0.5%) 1/147 (0.7%) 1/149 (0.7%)
Poor quality sleep 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Presyncope 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Sedation 5/665 (0.8%) 0/147 (0%) 0/149 (0%)
Sensory disturbance 0/665 (0%) 0/147 (0%) 2/149 (1.3%)
Sinus headache 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Somnolence 38/665 (5.7%) 6/147 (4.1%) 5/149 (3.4%)
Tension headache 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Tremor 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Psychiatric disorders
Abnormal dreams 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Agitation 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Anorgasmia 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Anxiety 3/665 (0.5%) 0/147 (0%) 0/149 (0%)
Bradyphrenia 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Confusional state 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Depressed mood 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Depression 6/665 (0.9%) 2/147 (1.4%) 2/149 (1.3%)
Depressive symptom 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Disorientation 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Euphoric mood 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Hallucination, visual 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Insomnia 11/665 (1.7%) 0/147 (0%) 2/149 (1.3%)
Libido decreased 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Mood swings 2/665 (0.3%) 1/147 (0.7%) 0/149 (0%)
Nervousness 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Nightmare 3/665 (0.5%) 1/147 (0.7%) 0/149 (0%)
Post-traumatic stress disorder 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Sleep disorder 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Suicidal ideation 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Thinking abnormal 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Renal and urinary disorders
Haematuria 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Nocturia 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Renal failure 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Renal failure acute 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Renal impairment 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Renal pain 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Urine odour abnormal 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Reproductive system and breast disorders
Erectile dysfunction 3/665 (0.5%) 0/147 (0%) 1/149 (0.7%)
Respiratory, thoracic and mediastinal disorders
Cough 3/665 (0.5%) 1/147 (0.7%) 1/149 (0.7%)
Dyspnoea 4/665 (0.6%) 1/147 (0.7%) 2/149 (1.3%)
Dyspnoea exertional 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Increased upper airway secretion 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Nasal congestion 2/665 (0.3%) 0/147 (0%) 0/149 (0%)
Oropharyngeal pain 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Painful respiration 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Pharyngeal oedema 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Productive cough 1/665 (0.2%) 0/147 (0%) 1/149 (0.7%)
Respiratory tract congestion 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Rhinitis allergic 0/665 (0%) 0/147 (0%) 2/149 (1.3%)
Sinus congestion 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Sleep apnoea syndrome 0/665 (0%) 2/147 (1.4%) 0/149 (0%)
Snoring 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Skin and subcutaneous tissue disorders
Acne 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Alopecia 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Blister 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Decubitus ulcer 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Dermal cyst 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Dry skin 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Eczema 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Heat rash 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Hyperhidrosis 4/665 (0.6%) 1/147 (0.7%) 0/149 (0%)
Hyperkeratosis 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Nail hypertrophy 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Pruritus 3/665 (0.5%) 0/147 (0%) 2/149 (1.3%)
Pruritus generalised 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Rash 4/665 (0.6%) 1/147 (0.7%) 0/149 (0%)
Rash macular 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Rash papular 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Rash pruritic 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Rosacea 1/665 (0.2%) 0/147 (0%) 0/149 (0%)
Skin discolouration 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Skin exfoliation 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Skin lesion 1/665 (0.2%) 1/147 (0.7%) 0/149 (0%)
Skin tightness 0/665 (0%) 1/147 (0.7%) 0/149 (0%)
Skin ulcer 2/665 (0.3%) 2/147 (1.4%) 1/149 (0.7%)
Swelling face 2/665 (0.3%) 1/147 (0.7%) 0/149 (0%)
Vascular disorders
Hypertension 2/665 (0.3%) 1/147 (0.7%) 0/149 (0%)
Hypotension 3/665 (0.5%) 1/147 (0.7%) 0/149 (0%)
Intermittent claudication 0/665 (0%) 0/147 (0%) 1/149 (0.7%)
Peripheral vascular disorder 0/665 (0%) 2/147 (1.4%) 0/149 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT01057693
Other Study ID Numbers:
  • A0081242
  • 2009-017389-21
First Posted:
Jan 27, 2010
Last Update Posted:
Jan 20, 2021
Last Verified:
Feb 1, 2019