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Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01455415
First received: October 17, 2011
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.


Condition Intervention Phase
Painful Diabetic Peripheral Neuropathy
Drug: pregabalin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of NSAID For Other Pain Conditions

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Endpoint mean pain score, based on the mean of the last 7 daily pain numeric rating scale (NRS) scores from the daily pain diaries while receiving study medication in each treatment period [ Time Frame: 6 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportions of 30% and 50% pain responders using NRS scores from the daily pain diary (Pain Diary) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change assessed at the end of Period 1 (PGIC) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • Daily Sleep Interference Rating Scale (Sleep Diary) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • Quality of life using Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QoL DN) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • European Quality of Life in 5 Dimensions (EQ 5D) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • Pain severity and impact using the Brief Pain Inventory - short form (BPI sf) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 6 week ] [ Designated as safety issue: No ]

Enrollment: 306
Study Start Date: December 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Pregabalin Drug: pregabalin
150 - 300 mg/day in divided dose (3 time a day) for 6 weeks
Placebo Comparator: 2: Placebo Drug: placebo
matching placebo 3 time a day

  Eligibility

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

Inclusion Criteria:

  • Type 1 or 2 diabetes with painful neuropathy
  • Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose
  • Meet pre-defined level of pain severity at entrance

Exclusion Criteria:

  • History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
  • Participated in a previous or ongoing pregabalin clinical trial
  • Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain
  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: NCT01455415

  Hide Study Locations
Locations
United States, Arizona
Dedicated Clinical Research
Goodyear, Arizona, United States, 85395
The Office of Joshua D. Holland, M.D.
Phoenix, Arizona, United States, 85053
Advanced Podiatry
Phoenix, Arizona, United States, 85032
Arizona Research Center
Phoenix, Arizona, United States, 85023
Clinical Research Consortium
Phoenix, Arizona, United States, 85004
Precision Trials
Phoenix, Arizona, United States, 85032
Clinical Research Consortium Arizona
Phoenix, Arizona, United States, 85003
Geneva Clinical Research
Tucson, Arizona, United States, 85704
United States, California
Neuro-Pain Medical Center
Fresno, California, United States, 93710
Center for United Research, Inc.
Lakewood, California, United States, 90712
HealthCare Partners Medical Group
Los Angeles, California, United States, 90015
IDS Pharmacy
Los Angeles, California, United States, 90033
National Research Institute
Los Angeles, California, United States, 90057
University of Southern California
Los Angeles, California, United States, 90033
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
United States, Connecticut
Coastal Connecticut Research, LLC
New London, Connecticut, United States, 06320
Neurological Group, PC
New London, Connecticut, United States, 06320
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Florida
Meridien Research
Bradenton, Florida, United States, 34208
Meridien Research
Brooksville, Florida, United States, 34601
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States, 33912
MD Clinical
Hallandale Beach, Florida, United States, 33009
AGA Clinical Trials
Hialeah, Florida, United States, 33012
Palm Beach Neurological Center,
Palm Beach Gardens, Florida, United States, 33418
Meridien Research
St. Petersburg, Florida, United States, 33709
Meridien Research
Tampa, Florida, United States, 33606
Clinical Research of Central Florida
Winter Haven, Florida, United States, 33880
United States, Georgia
Columbus Research Foundation
Columbus, Georgia, United States, 31904
United States, Illinois
Suburban Clinical Research
Chicago, Illinois, United States, 60624
Suburban Clinical Research
Naperville, Illinois, United States, 60564
United States, Kentucky
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, Louisiana
Arthritis and Diabetes Clinic, Inc.
Monroe, Louisiana, United States, 71203
United States, Massachusetts
Miray Medical Center
Brockton, Massachusetts, United States, 02301
Beacon Clinical Research, LLC
Brockton, Massachusetts, United States, 02301
Genesis Clinical Research, LLC
Fall River, Massachusetts, United States, 02720
United States, Michigan
Borgess Research Institute
Kalamazoo, Michigan, United States, 49048
Borgess Diabetes Center
Kalamazoo, Michigan, United States, 49048
United States, Missouri
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, Nebraska
Quality Clinical Research, Inc.
Omaha, Nebraska, United States, 68114
United States, Nevada
V.Jerome Mirkil, MD
Las Vegas, Nevada, United States, 89119
United States, New York
The Medical Research Network, LLC
New York, New York, United States, 10128
United States, North Carolina
Datum Clinical Research; Davidson Medical Ministries
Lexington, North Carolina, United States, 27292
United States, Ohio
Radiant Research
Columbus, Ohio, United States, 43212
United States, Oklahoma
Sooner Clinical Research
Oklahoma City, Oklahoma, United States, 73112
The Office of Veronique Sebastian, MD
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Sunstone Medical Research, LLC
Medford, Oregon, United States, 97504
United States, Pennsylvania
Blair Orthopedic Associates, Inc.
Altoona, Pennsylvania, United States, 16602
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Neurology and Pain Clinic, LLC
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
New Phase Research and Development
Knoxville, Tennessee, United States, 37919
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Centex Research, Inc.
Houston, Texas, United States, 77062
Centex Studies Inc. - Clear Lake Family Physicians (Admin Office)
Houston, Texas, United States, 77062
Houston Neurocare
Houston, Texas, United States, 77030
Czech Republic
UNARS, s.r.o.
Pelhrimov, Czech Republic, 39301
Clintrial, s.r.o.
Praha 10, Czech Republic, 100 00
Fakultni nemocnice v Motole
Praha 5, Czech Republic, 150 06
Italy
Fondazione PTV Policlinico Tor Vergata di Roma
Roma, Italy, 00133
Sweden
Center for Lakemedelsstudier
Malmo, Sweden, 211 52
Citydiabetes
Stockholm, Sweden, 111 57
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: NCT01455415     History of Changes
Other Study ID Numbers: A0081268
Study First Received: October 17, 2011
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 24, 2014