Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 4

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

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Pfizer Investigational Site
    • California
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • Torrance, California, United States, 90502
        • Pfizer Investigational Site
      • Torrance, California, United States, 90509
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • Pfizer Investigational Site
    • Florida
      • 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
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68116
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Pfizer Investigational Site
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Pfizer Investigational Site
      • New Brunswick, New Jersey, United States, 08903
        • Pfizer Investigational Site
      • New Brunswick, New Jersey, United States, 08901
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States, 12205
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14642
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14618
        • Pfizer Investigational Site
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Pfizer Investigational Site
    • Ohio
      • Toledo, Ohio, United States, 43623
        • Pfizer Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75214
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • 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:

  • 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.

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
Nerve conduction measurements; Pain scores from patient diaries

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

September 1, 2004

Primary Completion

December 7, 2022

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081060

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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