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Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159679
First received: September 8, 2005
Last updated: April 28, 2009
Last verified: April 2009
History of Changes
  Purpose

The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.


Condition Intervention Phase
Diabetic Neuropathy, Painful
 Drug: Pregabalin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy

Resource links provided by NLM:

Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Nerve conduction measurements; Pain scores from patient diaries

Secondary Outcome Measures:
  • Proportion of patients with at least a 50% reduction in pain scores; Short-Form McGill Pain Questionnaire; Sleep interference scores from patient diaries; Clinical Global Impression of Change; Patient Global Impression of Change

Enrollment: 167
Study Start Date: September 2004
Study Completion Date: October 2005
  Eligibility

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

Inclusion Criteria:

  • Adults with Type 1 or 2 diabetes
  • Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months

Exclusion Criteria:

  • Patients must not be in poor or unstable health.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159679

  Hide Study Locations
Locations
United States, Arkansas
Pfizer Investigational Site
Hot Springs, Arkansas, United States, 71913
United States, California
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
Torrance, California, United States, 90502
Pfizer Investigational Site
Torrance, California, United States, 90509
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80218
United States, Florida
Pfizer Investigational Site
Lake Worth, Florida, United States, 33462
Pfizer Investigational Site
Ocala, Florida, United States, 34471
Pfizer Investigational Site
Ocala, Florida, United States, 34474
Pfizer Investigational Site
Palm Beach Gardens, Florida, United States, 33410
Pfizer Investigational Site
Sunrise, Florida, United States, 33351-6637
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33401
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68116
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Pfizer Investigational Site
Englewood, New Jersey, United States, 07631
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08901
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08903
United States, New York
Pfizer Investigational Site
Albany, New York, United States, 12205
Pfizer Investigational Site
Rochester, New York, United States, 14618
Pfizer Investigational Site
Rochester, New York, United States, 14642
United States, North Carolina
Pfizer Investigational Site
Greenville, North Carolina, United States, 27834
United States, Ohio
Pfizer Investigational Site
Toledo, Ohio, United States, 43623
United States, Pennsylvania
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75214
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00159679     History of Changes
Other Study ID Numbers: A0081060
Study First Received: September 8, 2005
Last Updated: April 28, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Neuropathies
Pain
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
 Signs and Symptoms
Poisoning
Substance-Related Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 16, 2013