Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ponce, Puerto Rico, 00716
        • Pfizer Investigational Site
    • Alabama
      • Tuscaloosa, Alabama, United States, 35406
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Pfizer Investigational Site
    • California
      • La Mesa, California, United States, 91942
        • Pfizer Investigational Site
      • Los Gatos, California, United States, 95032-3739
        • Pfizer Investigational Site
      • Northridge, California, United States, 91325
        • Pfizer Investigational Site
      • Tustin, California, United States, 92780
        • Pfizer Investigational Site
      • Walnut Creek, California, United States, 94598
        • Pfizer Investigational Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Pfizer Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • Pfizer Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Pfizer Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • Pfizer Investigational Site
      • Hollywood, Florida, United States, 33021
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34471
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33606
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33407-2450
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30327
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30303
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60610
        • Pfizer Investigational Site
      • Peoria, Illinois, United States, 61602
        • Pfizer Investigational Site
      • Springfield, Illinois, United States, 62704
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02215
        • Pfizer Investigational Site
      • Springfield, Massachusetts, United States, 01104
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Pfizer Investigational Site
      • Tupelo, Mississippi, United States, 38803-4087
        • Pfizer Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68116-6465
        • Pfizer Investigational Site
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Pfizer Investigational Site
      • Shrewsbury, New Jersey, United States, 07702
        • Pfizer Investigational Site
    • New York
      • New Hyde Park, New York, United States, 11042
        • Pfizer Investigational Site
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
      • New York, New York, United States, 10022-1009
        • Pfizer Investigational Site
    • Ohio
      • Kettering, Ohio, United States, 45429
        • Pfizer Investigational Site
      • Toledo, Ohio, United States, 43623
        • Pfizer Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104-5428
        • Pfizer Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75390-8858
        • Pfizer Investigational Site
      • Frisco, Texas, United States, 75034
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78207
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Pfizer Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Pfizer Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females at least 18 years of age, of any ethnic origin
  • Type 1 or 2 diabetes mellitus
  • Pain score greater than or equal to 4 on the 11-point numeric pain rating scale

Exclusion Criteria:

  • Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
  • Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.

Secondary Outcome Measures

Outcome Measure
End of Week 12 responder rates, Brief Pain Inventory - short form, sleep interference scores, Medical Outcome Study - Sleep Scale, Hospital Anxiety and Depression Scale, Patient Global Impression of Change, Neuropathic Pain Inventory Symptom Inventory.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

April 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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