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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01057693
First received: January 26, 2010
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Diabetic Neuropathy, Painful
Drug: pregabalin (Lyrica)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3b Multicenter, Double-Blind, Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Inadequately Treated Painful Diabetic Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase [ Time Frame: SB Baseline, Week 19 (DB Phase) ] [ Designated as safety issue: No ]
    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:
  • Time to Loss of Pain Response (Double-Blind Phase) [ Time Frame: SB Baseline up to Week 19 ] [ Designated as safety issue: No ]
    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.

  • Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase [ Time Frame: SB Baseline, Week 6 (SB Phase) ] [ Designated as safety issue: No ]
    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.

  • Weekly Mean Pain Scores (Single-Blind Phase) [ Time Frame: Week 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
    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.

  • Weekly Mean Pain Scores (Double-Blind Phase) [ Time Frame: DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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.

  • Patient Global Impression of Change (PGIC) (Single-Blind Phase) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.

  • Patient Global Impression of Change (PGIC) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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.

  • Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ] [ Designated as safety issue: No ]
    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.

  • Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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.

  • Weekly Mean Sleep Interference Score (Single-Blind Phase) [ Time Frame: SB Baseline, Week 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
    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.

  • Weekly Mean Sleep Interference Score (Double-Blind Phase) [ Time Frame: DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 ] [ Designated as safety issue: No ]
    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).

  • Endpoint Mean Sleep Interference Score (Single-Blind Phase) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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).

  • Endpoint Mean Sleep Interference Score (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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).

  • Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ] [ Designated as safety issue: No ]
    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.

  • Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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.

  • Pain Visual Analog Scale (VAS) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ] [ Designated as safety issue: No ]
    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.

  • Pain Visual Analog Scale (VAS) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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.

  • Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ] [ Designated as safety issue: No ]
    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).

  • Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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).

  • Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ] [ Designated as safety issue: No ]
    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.

  • Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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.

  • Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.

  • Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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.


Enrollment: 665
Study Start Date: March 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pregabalin (Lyrica) Drug: pregabalin (Lyrica)
Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.
Other Name: pregabalin (Lyrica)
Placebo Comparator: Placebo Drug: Placebo
Placebo is supplied as capsules and given 3 times daily.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057693

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Locations
United States, Alabama
Greystone Medical Research, LLC
Birmingham, Alabama, United States, 35242
Neurology Clinic, PC
Northport, Alabama, United States, 35476
United States, Arizona
Horizon Clinical Research Associates, PLLC
Gilbert, Arizona, United States, 85295
Dedicated Clinical Research, Inc.
Goodyear, Arizona, United States, 85395
Dedicated Clinical Research
Goodyear, Arizona, United States, 85395
Novara Clinical Research
Mesa, Arizona, United States, 85206
Arizona Research Center
Phoenix, Arizona, United States, 85023
Radiant Research, Inc.
Scottsdale, Arizona, United States, 85251
Genova Clinical Research, Inc.
Tucson, Arizona, United States, 85704
United States, Arkansas
Central Arkansas Research
Hot Springs, Arkansas, United States, 71913
Little Rock Diagnostic Clinic
Little Rock, Arkansas, United States, 72205
United States, California
Convergys Clinical Research, Inc.
Anaheim, California, United States, 92805
Providence Clinical Research
Burbank, California, United States, 91505
Valley Research
Fresno, California, United States, 93720
Center for United Research, Inc.
Lakewood, California, United States, 90712
Healthcare Partners Medical Group
Los Angeles, California, United States, 90015
University of Southern California, Keck School of Medicine, Department of Neurology
Los Angeles, California, United States, 90033
Richard S. Cherlin, MD
Los Gatos, California, United States, 95032
Northridge Neurological Research
Northridge, California, United States, 91325
Remek Research
Pomona, California, United States, 91767
Sierra Clinical Research
Roseville, California, United States, 95661
CNRI-San Diego, LLC
San Diego, California, United States, 92102
San Diego Clinical Trials
San Diego, California, United States, 92120
Center for Clinical Research, Inc.
San Francisco, California, United States, 94115
Apex Research Institute
Santa Ana, California, United States, 92705
Neurological Research Institute
Santa Monica, California, United States, 90404
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
Foothills Pain Management
West Covina, California, United States, 91790
United States, Colorado
Aurora Family Medicine Center, PC
Aurora, Colorado, United States, 80012
Alpine Clinical Research Center, Inc.
Boulder, Colorado, United States, 80304
Mountain View Clinical Research
Denver, Colorado, United States, 80209
United States, Connecticut
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Florida
Metabolic Research Institute, Inc.
Boynton Beach, Florida, United States, 33472
Meridien Research
Bradenton, Florida, United States, 34208
Bradenton Research Center
Bradenton, Florida, United States, 34205
Meridien Research
Brooksville, Florida, United States, 34601
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States, 33756
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
Deerfield Beach Cardiology Research
Deerfield Beach, Florida, United States, 33442
Gulfcoast Clinical Research Center
Ft. Myers, Florida, United States, 33912
MD Clinical
Hallandale Beach, Florida, United States, 33009
Elite Research Institute
Miami, Florida, United States, 33169
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States, 34652
Laszlo J. Mate, MD
North Palm Beach, Florida, United States, 33408
Family Care Specialists, Inc.
Ocala, Florida, United States, 34471
Renstar Medical Research
Ocala, Florida, United States, 34471
Compass Research, LLC
Orlando, Florida, United States, 32806
Palm Beach Neurological Center, Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, United States, 33418
Drug Shipment Address:
Palm Harbor, Florida, United States, 34684
Suncoast Clinical Research
Palm Harbor, Florida, United States, 34684
Meridien Research
St. Petersburg, Florida, United States, 33709
Neurology Clinical Research, Inc.
Sunrise, Florida, United States, 33351
Clinical Research of West Florida, Inc.
Tampa, Florida, United States, 33603
Meridien Research
Tampa, Florida, United States, 33606
Clinical Research of Central Florida
Winter Haven, Florida, United States, 33880
United States, Georgia
NeuroTrials Research, Incorporated
Atlanta, Georgia, United States, 30342
CPM Research Institute
Austell, Georgia, United States, 30106
Columbus Research Foundation
Columbus, Georgia, United States, 31904
Rockdale Medical Research Associates
Conyers, Georgia, United States, 30094
Valley Health Care
Rome, Georgia, United States, 30165
Prism Research Group
Rome, Georgia, United States, 30165
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
United States, Idaho
Advanced Clinical Research
Meridian, Idaho, United States, 83642
United States, Illinois
AMR Sakeena Research
Aurora, Illinois, United States, 60504
Chicago Research Center, Inc.
Chicago, Illinois, United States, 60634
American Medical Research, Inc.
Oak Brook, Illinois, United States, 60523
United States, Indiana
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
American Health Network
Greenfield, Indiana, United States, 46140
Rehabilitation Associates of Indiana
Indianapolis, Indiana, United States, 46250
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
Kentucky Medical Research Center
Lexington, Kentucky, United States, 40504
United States, Louisiana
Primary Physician Care, LLC
Lake Charles, Louisiana, United States, 70601
Heartland Research, LLC
Lake Charles, Louisiana, United States, 70601
Endocrinology Center of Southwest Louisiana
Lake Charles, Louisiana, United States, 70601
Arthritis and Diabetes Clinic, Inc
Monroe, Louisiana, United States, 71203
United States, Massachusetts
Miray Medical Center
Brockton, Massachusetts, United States, 02301
Clinical Research Center of Cape Cod, Inc.
Hyannis, Massachusetts, United States, 02601
MedVadis Research Corporation
WaterTown, Massachusetts, United States, 02472
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01610
United States, Michigan
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States, 48104
Harris and Associates MD, PC
Detroit, Michigan, United States, 48235
Borgess Research Institute
Kalamazoo, Michigan, United States, 49048
Borgess Diabetes Center
Kalamazoo, Michigan, United States, 49048
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
KMED Research
St. Clair Shores, Michigan, United States, 48081
William Beaumont Hospital
Troy, Michigan, United States, 48085
Troy Internal Medicine, PC
Troy, Michigan, United States, 48098
United States, Minnesota
Medical Advanced Pain Specialists (MAPS)
Edina, Minnesota, United States, 55435
MAPS Applied Research Center, Inc.
Edina, Minnesota, United States, 55435
Medical Advanced Pain Specialists
Maple Grove, Minnesota, United States, 55369
Medical Advanced Pain Specialists
Shakopee, Minnesota, United States, 55379
United States, Mississippi
Physician's Surgery Center
Jackson, Mississippi, United States, 39202
CRC of Jackson
Jackson, Mississippi, United States, 39202
Randall T. Huling, Jr., MD, CPI
Olive Branch, Mississippi, United States, 38654
United States, Missouri
University of Missouri Healthcare/Cosmopolitan Diabetes and Endocrinology Center
Columbia, Missouri, United States, 65212
Melinda A. Crockett-Maples
Marionville, Missouri, United States, 65705
Clinvest
Springfield, Missouri, United States, 65807
A & A Pain Institute of Saint Louis
St Louis, Missouri, United States, 63141
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, Nebraska
Lincoln Internal Medicine Associates
Lincoln, Nebraska, United States, 68516
United States, Nevada
Desert Endocrinology Clinical Research Center
Henderson, Nevada, United States, 89052
Desert Endocrinology
Las Vegas, Nevada, United States, 89117
Office of Dr. Danka Michaels, MD
Las Vegas, Nevada, United States, 89128
Office of Stephen Miller, M.D.
Las Vegas, Nevada, United States, 89144
United States, North Carolina
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, United States, 27607-6520
Carolina Pharmaceutical Research
Statesville, North Carolina, United States, 28625
United States, Ohio
Radiant Research, Inc.
Akron, Ohio, United States, 44311
Community Research
Cincinnati, Ohio, United States, 45245
Radiant Research
Cincinnati, Ohio, United States, 45249
Providence Health Partners - Center for Clinical Research
Dayton, Ohio, United States, 45439
Hometown Urgent Care and Research
Dayton, Ohio, United States, 45432
United States, Oklahoma
Sooner Clinical Research
Oklahoma City, Oklahoma, United States, 73112
Angelique Barreto, MD
Oklahoma City, Oklahoma, United States, 73134
Veronique Sebastian, MD
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Study drug shipments should be sent to:
Portland, Oregon, United States, 97239
United States, Pennsylvania
Blair Orthopedic Associates, Inc.
Altoona, Pennsylvania, United States, 16602
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Research Protocol Management Specialists
Pittsburg, Pennsylvania, United States, 15243
United States, Rhode Island
Coastal Medical
East Greenwich, Rhode Island, United States, 02818
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Aiken Center for Clinical Research
Aiken, South Carolina, United States, 29801
TLM Medical Services, LLC
Columbia, South Carolina, United States, 29204
Radiant Research Inc.
Greer, South Carolina, United States, 29651
Neurology and Pain Clinic, LLC
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, United States, 37403
SCRI Research Center
Germantown, Tennessee, United States, 38138
Sarah Cannon Research Institute
Jackson, Tennessee, United States, 38305
AM Diabetes & Endocrinology Center
Memphis, Tennessee, United States, 38133
Memphis Internal Medicine
Memphis, Tennessee, United States, 38138
United States, Texas
ClinRx Research LLC
Carrollton, Texas, United States, 75007
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8858
Baylor University Medical Center
Dallas, Texas, United States, 75246
Medical Group of Texas
Ft. Worth, Texas, United States, 76104
The Nerve and Muscle Center of Texas
Houston, Texas, United States, 77030
ClinRx Research, LLC
Richardson, Texas, United States, 75080
Cetero Research - San Antonio
San Antonio, Texas, United States, 78229
Paragon Research Center, LLC
San Antonio, Texas, United States, 78205
Alamo Clinical Research
San Antonio, Texas, United States, 78212
Pioneer Research Solutions, Inc
Sugar Land, Texas, United States, 77479
United States, Utah
L. Craig Larsen and Clark C. Larsen
Murray, Utah, United States, 84107
Aspen Clinical Research
Orem, Utah, United States, 84058
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
Daniel B. Vine, MD
Salt Lake City, Utah, United States, 84107
Foot and Ankle Clinic
West Jordan, Utah, United States, 84088
United States, Virginia
Neurological Associates, Incorporated
Henrico, Virginia, United States, 23226
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, United States, 23502
United States, Washington
Spokane Internal Medicine
Spokane, Washington, United States, 99216
United States, Wisconsin
Aurora Advanced Healthcare, Inc.
Milwaukee, Wisconsin, United States, 53209
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N4Z6
Canada, Manitoba
Winnipeg Regional Health Authority Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada, R3E 3P4
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7
Capital District Health Authority, Division of Endocrinology
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
The Ottawa Hospital, Riverside Campus - Riverside Professional Building
Ottawa, Ontario, Canada, K1H 1A2
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Puerto Rico
Ponce School of Medicine & Health Sciences
Ponce, Puerto Rico, 00716
Instituto de Endocrinologia Diabetes y Metabolismo
Toa Baja, Puerto Rico, 00949
South Africa
Bloemfontein Medi-Clinic
Bloemfontein, Free State, South Africa, 9301
Dr Makan's Rooms
Johannesburg, Gauteng, South Africa, 1827
Chris Hani Baragwanath Hospital
Soweto, Gauteng, South Africa, 2013
Randles Road Medical Centre
Durban, Kwa-Zulu Natal, South Africa, 4000
Chelmsford Medical Centre
Durban, Kwazulu Natal, South Africa, 4001
Parklands Medical Centre
Overport, Kwazulu Natal, South Africa, 4091
Dr Jeevren Reddy's Surgery
Stanger, Kwazulu Natal, South Africa, 4450
Dot Shuttleworth Centre for Diabetes
Durban, Overport, South Africa, 4091
Centre for Diabetes and Endocrinology
Houghton, Johannesburg, South Africa, 2198
102 Parklands Medical Centre
Overport, Durban, South Africa, 4001
Dr's Sauermann and Meyer
Polokwane, South Africa
Diabetes Care Centre
Pretoria, South Africa, 0001
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01057693     History of Changes
Other Study ID Numbers: A0081242
Study First Received: January 26, 2010
Results First Received: January 18, 2013
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Diabetic peripheral neuropathy
Lyrica
pregabalin
pain

Additional relevant MeSH terms:
Pain
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neuromuscular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 22, 2014