A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)

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

A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN).

A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

450

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

        • Pfizer Investigational Site
  • Argentina
      • Buenos Aires, Argentina
        • Pfizer Investigational Site
  • Brazil
    • MG
      • Belo Horizonte, MG, Brazil
        • Pfizer Investigational Site
    • RJ
      • Niteroi, RJ, Brazil
        • Pfizer Investigational Site
  • Chile
    • Santiago
      • Providencia, Santiago, Chile
        • Pfizer Investigational Site
    • V Region
      • Valparaiso, V Region, Chile
        • Pfizer Investigational Site
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia
        • Pfizer Investigational Site
  • Ecuador
    • Pichincha
      • Quito, Pichincha, Ecuador
        • Pfizer Investigational Site
  • Indonesia
      • Jakarta Pusat, Indonesia
        • Pfizer Investigational Site
      • Surabaya, Indonesia
        • Pfizer Investigational Site
  • Jordan
      • Amman, Jordan
        • Pfizer Investigational Site
  • Korea, Republic of
      • Pusan, Korea, Republic of
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of
        • Pfizer Investigational Site
  • Lebanon
      • Beirut, Lebanon
        • Pfizer Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Pfizer Investigational Site
  • Mexico
      • Mexico Df, Mexico
        • Pfizer Investigational Site
      • San Luis Potosi, Mexico
        • Pfizer Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Pfizer Investigational Site
  • Philippines
      • Quezon City, Philippines
        • Pfizer Investigational Site
    • Manila
      • Espana, Manila, Philippines
        • Pfizer Investigational Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore
        • Pfizer Investigational Site
  • Taiwan
      • Taipei, Taiwan
        • Pfizer Investigational Site
    • Taoyan Hsien
      • Gueishan Shiang, Taoyan Hsien, Taiwan
        • Pfizer Investigational Site
  • Thailand
    • Bangkok
      • Khet Rajathevee, Bangkok, Thailand
        • Pfizer Investigational Site
    • Chiang MAI
      • Muang, Chiang MAI, Thailand
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey
        • Pfizer Investigational Site
      • Istanbul, Turkey
        • Pfizer Investigational Site
      • Izmir, Turkey
        • Pfizer Investigational Site
      • Mersin, Turkey
        • Pfizer Investigational Site
    • Istanbul
      • Capa, Istanbul, Turkey
        • Pfizer Investigational Site
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Pfizer Investigational Site
  • Venezuela
    • Caracas-Estado Miranda
      • El Hatillo, Caracas-Estado Miranda, Venezuela
        • Pfizer Investigational Site
    • Distrito Capital
      • Caracas, Distrito Capital, Venezuela
        • 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Type 1 or 2 diabetes mellitus.
  • Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.

Exclusion Criteria:

  • Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
  • Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.

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
Mean pain score

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

Helpful Links

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

January 1, 2005

Study Completion

May 1, 2007

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 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

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081030

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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