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

Primary Purpose

Diabetic Neuropathy, Painful

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pregabalin (Lyrica)
Placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy, Painful focused on measuring Diabetic peripheral neuropathy, Lyrica, pregabalin, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Greystone Medical Research, LLC
  • Neurology Clinic, PC
  • Horizon Clinical Research Associates, PLLC
  • Dedicated Clinical Research, Inc.
  • Dedicated Clinical Research
  • Novara Clinical Research
  • Arizona Research Center
  • Radiant Research, Inc.
  • Genova Clinical Research, Inc.
  • Central Arkansas Research
  • Little Rock Diagnostic Clinic
  • Convergys Clinical Research, Inc.
  • Providence Clinical Research
  • Valley Research
  • Center for United Research, Inc.
  • Healthcare Partners Medical Group
  • University of Southern California, Keck School of Medicine, Department of Neurology
  • Richard S. Cherlin, MD
  • Northridge Neurological Research
  • Remek Research
  • Sierra Clinical Research
  • CNRI-San Diego, LLC
  • San Diego Clinical Trials
  • Center for Clinical Research, Inc.
  • Apex Research Institute
  • Neurological Research Institute
  • Diablo Clinical Research, Inc.
  • Foothills Pain Management
  • Aurora Family Medicine Center, PC
  • Alpine Clinical Research Center, Inc.
  • Mountain View Clinical Research
  • Chase Medical Research, LLC
  • Metabolic Research Institute, Inc.
  • Bradenton Research Center
  • Meridien Research
  • Meridien Research
  • Innovative Research of West Florida, Inc.
  • Clinical Research of West Florida, Inc.
  • Deerfield Beach Cardiology Research
  • Gulfcoast Clinical Research Center
  • MD Clinical
  • Elite Research Institute
  • Suncoast Clinical Research, Inc.
  • Laszlo J. Mate, MD
  • Family Care Specialists, Inc.
  • Renstar Medical Research
  • Compass Research, LLC
  • Palm Beach Neurological Center, Advanced Research Consultants, Inc.
  • Suncoast Clinical Research
  • Meridien Research
  • Neurology Clinical Research, Inc.
  • Clinical Research of West Florida, Inc.
  • Meridien Research
  • Clinical Research of Central Florida
  • NeuroTrials Research, Incorporated
  • CPM Research Institute
  • Columbus Research Foundation
  • Rockdale Medical Research Associates
  • Prism Research Group
  • Valley Health Care
  • East-West Medical Research Institute
  • Advanced Clinical Research
  • AMR Sakeena Research
  • Chicago Research Center, Inc.
  • American Medical Research, Inc.
  • MediSphere Medical Research Center, LLC
  • American Health Network
  • Rehabilitation Associates of Indiana
  • University of Kansas Medical Center
  • Heartland Research Associates, LLC
  • Kentucky Medical Research Center
  • Endocrinology Center of Southwest Louisiana
  • Heartland Research, LLC
  • Primary Physician Care, LLC
  • Arthritis and Diabetes Clinic, Inc
  • Miray Medical Center
  • Clinical Research Center of Cape Cod, Inc.
  • MedVadis Research Corporation
  • Clinical Pharmacology Study Group
  • Michigan Head Pain and Neurological Institute
  • Harris and Associates MD, PC
  • Borgess Diabetes Center
  • Borgess Research Institute
  • William Beaumont Hospital
  • KMED Research
  • William Beaumont Hospital
  • Troy Internal Medicine, PC
  • MAPS Applied Research Center, Inc.
  • Medical Advanced Pain Specialists (MAPS)
  • Medical Advanced Pain Specialists
  • Medical Advanced Pain Specialists
  • CRC of Jackson
  • Physician's Surgery Center
  • Randall T. Huling, Jr., MD, CPI
  • University of Missouri Healthcare/Cosmopolitan Diabetes and Endocrinology Center
  • Melinda A. Crockett-Maples
  • A & A Pain Institute of Saint Louis
  • Mercy Health Research
  • Clinvest
  • Lincoln Internal Medicine Associates
  • Desert Endocrinology Clinical Research Center
  • Desert Endocrinology
  • Office of Dr. Danka Michaels, MD
  • Office of Stephen Miller, M.D.
  • Raleigh Neurology Associates, P.A.
  • Carolina Pharmaceutical Research
  • Radiant Research, Inc.
  • Community Research
  • Radiant Research
  • Hometown Urgent Care and Research
  • Providence Health Partners - Center for Clinical Research
  • Sooner Clinical Research
  • Veronique Sebastian, MD
  • Angelique Barreto, MD
  • Oregon Health & Science University
  • Blair Orthopedic Associates, Inc.
  • Altoona Center for Clinical Research
  • Research Protocol Management Specialists
  • Coastal Medical
  • Memorial Hospital of Rhode Island
  • Omega Medical Research
  • Aiken Center for Clinical Research
  • TLM Medical Services, LLC
  • Radiant Research Inc.
  • Neurology and Pain Clinic, LLC
  • University Diabetes & Endocrine Consultants
  • SCRI Research Center
  • Sarah Cannon Research Institute
  • AM Diabetes & Endocrinology Center
  • Memphis Internal Medicine
  • ClinRx Research LLC
  • Baylor University Medical Center
  • University of Texas Southwestern Medical Center at Dallas
  • Medical Group of Texas
  • The Nerve and Muscle Center of Texas
  • ClinRx Research, LLC
  • Paragon Research Center, LLC
  • Alamo Clinical Research
  • Cetero Research - San Antonio
  • Pioneer Research Solutions, Inc
  • L. Craig Larsen and Clark C. Larsen
  • Aspen Clinical Research
  • Daniel B. Vine, MD
  • Wasatch Clinical Research
  • Jean Brown Research
  • Foot and Ankle Clinic
  • Neurological Associates, Incorporated
  • National Clinical Research - Norfolk, Inc.
  • Spokane Internal Medicine
  • Aurora Advanced Healthcare, Inc.
  • University of Calgary
  • Winnipeg Health Sciences Centre
  • Winnipeg Regional Health Authority Sciences Centre Winnipeg
  • Capital District Health Authority, QEII Health Sciences Centre
  • Capital District Health Authority, QEII Health Sciences Centre
  • The Ottawa Hospital, Riverside Campus - Riverside Professional Building
  • Toronto General Hospital
  • Ponce School of Medicine & Health Sciences
  • Instituto de Endocrinologia Diabetes y Metabolismo
  • Bloemfontein Medi-Clinic
  • Dr Makan's Rooms
  • Chris Hani Baragwanath Hospital
  • Randles Road Medical Centre
  • Chelmsford Medical Centre
  • Centre for Diabetes and Endocrinology
  • Parklands Medical Centre
  • Dr Jeevren Reddy's Surgery
  • Dot Shuttleworth Centre for Diabetes
  • Centre for Diabetes and Endocrinology
  • 102 Parklands Medical Centre
  • Dr's Sauermann and Meyer
  • Diabetes Care Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pregabalin (Lyrica)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.

Full Information

First Posted
January 26, 2010
Last Updated
January 15, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01057693
Brief Title
Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 31, 2010 (Actual)
Primary Completion Date
January 30, 2012 (Actual)
Study Completion Date
January 30, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Painful
Keywords
Diabetic peripheral neuropathy, Lyrica, pregabalin, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
633 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pregabalin (Lyrica)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pregabalin (Lyrica)
Intervention Description
Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is supplied as capsules and given 3 times daily.
Primary Outcome Measure Information:
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)
Secondary Outcome Measure Information:
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
23887339
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081242&StudyName=Study%20Of%20Pregabalin%20%28Lyrica%29%20In%20Patients%20With%20Painful%20Diabetic%20Peripheral%20Neuropathy
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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