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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Neuropathy, Painful
• Intervention / Treatment: Drug: pregabalin (Lyrica); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 633
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N4Z6
      • University of Calgary
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Winnipeg Health Sciences Centre
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Winnipeg Regional Health Authority Sciences Centre Winnipeg
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Capital District Health Authority, QEII Health Sciences Centre
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Capital District Health Authority, QEII Health Sciences Centre
  • Ontario
    • Ottawa, Ontario, Canada, K1H 1A2
      • The Ottawa Hospital, Riverside Campus - Riverside Professional Building
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Ponce School of Medicine & Health Sciences
  • Toa Baja, Puerto Rico, 00949
    • Instituto de Endocrinologia Diabetes y Metabolismo
• South Africa
  • Houghton, Johannesburg, South Africa, 2198
    • Centre for Diabetes and Endocrinology
  • Overport, Durban, South Africa, 4001
    • 102 Parklands Medical Centre
  • Polokwane, South Africa
    • Dr's Sauermann and Meyer
  • Pretoria, South Africa, 0001
    • Diabetes Care Centre
  • FREE State
    • Bloemfontein, FREE State, South Africa, 9301
      • Bloemfontein Medi-Clinic
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1827
      • Dr Makan's Rooms
    • Soweto, Gauteng, South Africa, 2013
      • Chris Hani Baragwanath Hospital
  • Kwa-zulu Natal
    • Durban, Kwa-zulu Natal, South Africa, 4000
      • Randles Road Medical Centre
  • Kwazulu Natal
    • Durban, Kwazulu Natal, South Africa, 4001
      • Chelmsford Medical Centre
    • Durban, Kwazulu Natal, South Africa, 4091
      • Centre for Diabetes and Endocrinology
    • Overport, Kwazulu Natal, South Africa, 4091
      • Parklands Medical Centre
    • Stanger, Kwazulu Natal, South Africa, 4450
      • Dr Jeevren Reddy's Surgery
  • Overport
    • Durban, Overport, South Africa, 4091
      • Dot Shuttleworth Centre for Diabetes
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Greystone Medical Research, LLC
    • Northport, Alabama, United States, 35476
      • Neurology Clinic, PC
  • Arizona
    • Gilbert, Arizona, United States, 85295
      • Horizon Clinical Research Associates, PLLC
    • Goodyear, Arizona, United States, 85395
      • Dedicated Clinical Research
    • Goodyear, Arizona, United States, 85395
      • Dedicated Clinical Research, Inc.
    • Mesa, Arizona, United States, 85206
      • Novara Clinical Research
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
    • Scottsdale, Arizona, United States, 85251
      • Radiant Research, Inc.
    • Tucson, Arizona, United States, 85704
      • Genova Clinical Research, Inc.
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Central Arkansas Research
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Diagnostic Clinic
  • California
    • Anaheim, California, United States, 92805
      • Convergys Clinical Research, Inc.
    • Burbank, California, United States, 91505
      • Providence Clinical Research
    • Fresno, California, United States, 93720
      • Valley Research
    • Lakewood, California, United States, 90712
      • Center For United Research, Inc.
    • Los Angeles, California, United States, 90015
      • HealthCare Partners Medical Group
    • Los Angeles, California, United States, 90033
      • University of Southern California, Keck School of Medicine, Department of Neurology
    • Los Gatos, California, United States, 95032
      • Richard S. Cherlin, MD
    • Northridge, California, United States, 91325
      • Northridge Neurological Research
    • Pomona, California, United States, 91767
      • REMEK Research
    • Roseville, California, United States, 95661
      • Sierra Clinical Research
    • San Diego, California, United States, 92120
      • San Diego Clinical Trials
    • San Diego, California, United States, 92102
      • CNRI-San Diego, LLC
    • San Francisco, California, United States, 94115
      • Center for Clinical Research, Inc.
    • Santa Ana, California, United States, 92705
      • Apex Research Institute
    • Santa Monica, California, United States, 90404
      • Neurological Research Institute
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
    • West Covina, California, United States, 91790
      • Foothills Pain Management
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Aurora Family Medicine Center, PC
    • Boulder, Colorado, United States, 80304
      • Alpine Clinical Research Center, Inc.
    • Denver, Colorado, United States, 80209
      • Mountain View Clinical Research
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Metabolic Research Institute, Inc.
    • Bradenton, Florida, United States, 34208
      • Meridien Research
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center
    • Brooksville, Florida, United States, 34601
      • Meridien Research
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida, Inc.
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc.
    • Deerfield Beach, Florida, United States, 33442
      • Deerfield Beach Cardiology Research
    • Fort Myers, Florida, United States, 33912
      • Gulfcoast Clinical Research Center
    • Hallandale Beach, Florida, United States, 33009
      • MD Clinical
    • Miami, Florida, United States, 33169
      • Elite Research Institute
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
    • North Palm Beach, Florida, United States, 33408
      • Laszlo J. Mate, MD
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Ocala, Florida, United States, 34471
      • Family Care Specialists, Inc.
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Palm Beach Gardens, Florida, United States, 33418
      • Palm Beach Neurological Center, Advanced Research Consultants, Inc.
    • Palm Harbor, Florida, United States, 34684
      • Suncoast Clinical Research
    • Saint Petersburg, Florida, United States, 33709
      • Meridien Research
    • Sunrise, Florida, United States, 33351
      • Neurology Clinical Research, Inc.
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida, Inc.
    • Tampa, Florida, United States, 33606
      • Meridien Research
    • Winter Haven, Florida, United States, 33880
      • Clinical Research of Central Florida
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • NeuroTrials Research, Incorporated
    • Austell, Georgia, United States, 30106
      • CPM Research Institute
    • Columbus, Georgia, United States, 31904
      • Columbus Research Foundation
    • Conyers, Georgia, United States, 30094
      • Rockdale Medical Research Associates
    • Rome, Georgia, United States, 30165
      • Valley Health Care
    • Rome, Georgia, United States, 30165
      • Prism Research Group
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research
  • Illinois
    • Aurora, Illinois, United States, 60504
      • AMR Sakeena Research
    • Chicago, Illinois, United States, 60634
      • Chicago Research Center, Inc.
    • Oak Brook, Illinois, United States, 60523
      • American Medical Research, Inc.
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Medisphere Medical Research Center, Llc
    • Greenfield, Indiana, United States, 46140
      • American Health Network
    • Indianapolis, Indiana, United States, 46250
      • Rehabilitation Associates of Indiana
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Kentucky Medical Research Center
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Endocrinology Center of Southwest Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Heartland Research, LLC
    • Lake Charles, Louisiana, United States, 70601
      • Primary Physician Care, LLC
    • Monroe, Louisiana, United States, 71203
      • Arthritis and Diabetes Clinic, Inc
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Miray Medical Center
    • Hyannis, Massachusetts, United States, 02601
      • Clinical Research Center of Cape Cod, Inc.
    • Watertown, Massachusetts, United States, 02472
      • MedVadis Research Corporation
    • Worcester, Massachusetts, United States, 01605
      • Clinical Pharmacology Study Group
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head Pain and Neurological Institute
    • Detroit, Michigan, United States, 48235
      • Harris and Associates MD, PC
    • Kalamazoo, Michigan, United States, 49048
      • Borgess Research Institute
    • Kalamazoo, Michigan, United States, 49048
      • Borgess Diabetes Center
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
    • Saint Clair Shores, Michigan, United States, 48081
      • KMED Research
    • Troy, Michigan, United States, 48085
      • William Beaumont Hospital
    • Troy, Michigan, United States, 48098
      • Troy Internal Medicine, PC
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • MAPS Applied Research Center, Inc.
    • Edina, Minnesota, United States, 55435
      • Medical Advanced Pain Specialists (MAPS)
    • Maple Grove, Minnesota, United States, 55369
      • Medical Advanced Pain Specialists
    • Shakopee, Minnesota, United States, 55379
      • Medical Advanced Pain Specialists
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • CRC of Jackson
    • Jackson, Mississippi, United States, 39202
      • Physician's Surgery Center
    • Olive Branch, Mississippi, United States, 38654
      • Randall T. Huling, Jr., MD, CPI
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Healthcare/Cosmopolitan Diabetes and Endocrinology Center
    • Marionville, Missouri, United States, 65705
      • Melinda A. Crockett-Maples
    • Saint Louis, Missouri, United States, 63141
      • Mercy Health Research
    • Saint Louis, Missouri, United States, 63141
      • A & A Pain Institute of Saint Louis
    • Springfield, Missouri, United States, 65807
      • Clinvest
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Lincoln Internal Medicine Associates
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Desert Endocrinology Clinical Research Center
    • Las Vegas, Nevada, United States, 89128
      • Office of Dr. Danka Michaels, MD
    • Las Vegas, Nevada, United States, 89117
      • Desert Endocrinology
    • Las Vegas, Nevada, United States, 89144
      • Office of Stephen Miller, M.D.
  • North Carolina
    • Raleigh, North Carolina, United States, 27607-6520
      • Raleigh Neurology Associates, P.A.
    • Statesville, North Carolina, United States, 28625
      • Carolina Pharmaceutical Research
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research, Inc.
    • Cincinnati, Ohio, United States, 45245
      • Community Research
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research
    • Dayton, Ohio, United States, 45439
      • Providence Health Partners - Center For Clinical Research
    • Dayton, Ohio, United States, 45432
      • Hometown Urgent Care and Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Sooner Clinical Research
    • Oklahoma City, Oklahoma, United States, 73120
      • Veronique Sebastian, MD
    • Oklahoma City, Oklahoma, United States, 73134
      • Angelique Barreto, MD
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • Oregon Health & Science University
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Blair Orthopedic Associates, Inc.
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Pittsburgh, Pennsylvania, United States, 15243
      • Research Protocol Management Specialists
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Coastal Medical
    • Pawtucket, Rhode Island, United States, 02860
      • Memorial Hospital of Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Carolina
    • Aiken, South Carolina, United States, 29801
      • Aiken Center for Clinical Research
    • Columbia, South Carolina, United States, 29204
      • TLM Medical Services, LLC
    • Greer, South Carolina, United States, 29651
      • Radiant Research Inc.
    • Orangeburg, South Carolina, United States, 29118
      • Neurology and Pain Clinic, LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • University Diabetes & Endocrine Consultants
    • Germantown, Tennessee, United States, 38138
      • SCRI Research Center
    • Jackson, Tennessee, United States, 38305
      • Sarah Cannon Research Institute
    • Memphis, Tennessee, United States, 38133
      • AM Diabetes & Endocrinology Center
    • Memphis, Tennessee, United States, 38138
      • Memphis Internal Medicine
  • Texas
    • Carrollton, Texas, United States, 75007
      • ClinRx Research LLC
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Dallas, Texas, United States, 75390-8858
      • University of Texas Southwestern Medical Center at Dallas
    • Fort Worth, Texas, United States, 76104
      • Medical Group of Texas
    • Houston, Texas, United States, 77030
      • The Nerve and Muscle Center of Texas
    • Richardson, Texas, United States, 75080
      • ClinRx Research, LLC
    • San Antonio, Texas, United States, 78212
      • Alamo Clinical Research
    • San Antonio, Texas, United States, 78205
      • Paragon Research Center, LLC
    • San Antonio, Texas, United States, 78229
      • Cetero Research - San Antonio
    • Sugar Land, Texas, United States, 77479
      • Pioneer Research Solutions, Inc
  • Utah
    • Murray, Utah, United States, 84107
      • L. Craig Larsen and Clark C. Larsen
    • Orem, Utah, United States, 84058
      • Aspen Clinical Research
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
    • Salt Lake City, Utah, United States, 84107
      • Daniel B. Vine, MD
    • West Jordan, Utah, United States, 84088
      • Foot and Ankle Clinic
  • Virginia
    • Henrico, Virginia, United States, 23226
      • Neurological Associates, Incorporated
    • Norfolk, Virginia, United States, 23502
      • National Clinical Research - Norfolk, Inc.
  • Washington
    • Spokane, Washington, United States, 99216
      • Spokane Internal Medicine
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Aurora Advanced Healthcare, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo is supplied as capsules and given 3 times daily.
Experimental: pregabalin (Lyrica)	Drug: pregabalin (Lyrica); Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind 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.	SB Baseline, Week 19 (DB Phase)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Loss of Pain Response (Double-Blind Phase)	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.	SB Baseline up to Week 19
Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind 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.	SB Baseline, Week 6 (SB Phase)
Weekly Mean Pain Scores (Single-Blind Phase)	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.	Week 1, 2, 3, 4, 5, 6
Weekly Mean Pain Scores (Double-Blind Phase)	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.	DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind 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. 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.	Week 6
Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind 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. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported.	Week 19
Patient Global Impression of Change (PGIC) (Single-Blind Phase)	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.	Week 6
Patient Global Impression of Change (PGIC) (Double-Blind Phase)	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.	Week 19
Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)	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.	SB Baseline, Week 6
Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase)	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.	Week 19
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase)	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.	SB Baseline, Week 6
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)	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.	Week 19
Weekly Mean Sleep Interference Score (Single-Blind Phase)	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.	SB Baseline, Week 1, 2, 3, 4, 5, 6
Weekly Mean Sleep Interference Score (Double-Blind Phase)	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).	DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
Endpoint Mean Sleep Interference Score (Single-Blind Phase)	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).	Week 6
Endpoint Mean Sleep Interference Score (Double-Blind Phase)	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).	Week 19
Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase)	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.	SB Baseline, Week 6
Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase)	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.	Week 19
Pain Visual Analog Scale (VAS) (Single-Blind Phase)	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.	SB Baseline, Week 6
Pain Visual Analog Scale (VAS) (Double-Blind Phase)	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.	Week 19
Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)	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).	SB Baseline, Week 6
Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase)	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).	Week 19
Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase)	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.	SB Baseline, Week 6
Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase)	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.	Week 19
Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase)	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.	Week 6
Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)	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.	Week 19

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Raskin P, Huffman C, Toth C, Asmus MJ, Messig M, Sanchez RJ, Pauer L. Pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy: a randomized withdrawal trial. Clin J Pain. 2014 May;30(5):379-90. doi: 10.1097/AJP.0b013e31829ea1a1.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2010
• Primary Completion (Actual): January 30, 2012
• Study Completion (Actual): January 30, 2012

Study Registration Dates

• First Submitted: January 26, 2010
• First Submitted That Met QC Criteria: January 26, 2010
• First Posted (Estimate): January 27, 2010

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: pain; pregabalin; Lyrica; Diabetic peripheral neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain; Diabetic Neuropathies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081242; 2009-017389-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.