Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy

January 20, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

An Open-Label, Extension Safety And Efficacy Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With Human Immunodeficiency Virus (HIV) Neuropathy

To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

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

  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Pfizer Investigational Site
      • San Juan, Puerto Rico, 00909-1711
        • Pfizer Investigational Site
      • San Juan, Puerto Rico, 00936
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72207
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90028
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90025
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95817-1460
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94117
        • Pfizer Investigational Site
      • Stanford, California, United States, 94305-5235
        • Pfizer Investigational Site
      • West Hollywood, California, United States, 90069
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80262
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, United States, 33133
        • Pfizer Investigational Site
      • Pensacola, Florida, United States, 32504-5719
        • Pfizer Investigational Site
      • Safety Harbor, Florida, United States, 34695
        • Pfizer Investigational Site
      • Vero Beach, Florida, United States, 32960
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21287-7609
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215-3318
        • Pfizer Investigational Site
      • Springfield, Massachusetts, United States, 01107
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States, 63110-1010
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10021
        • Pfizer Investigational Site
      • New York, New York, United States, 10029
        • Pfizer Investigational Site
      • New York, New York, United States, 10018
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14642
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75204
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75208-4234
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75390-9036
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98104
        • 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:

  • Participation in the preceding A0081066 double-blind trial met the entry criteria for that trial and completed A0081066 study through visit 7

Exclusion Criteria:

  • Experienced serious adverse event during the A0081066 trial that was considered related or possibly related to study medication by the investigator or sponsor
  • non-compliant during A0081066 trial
  • clinically significant or unstable medical condition both HIV-related and non-HIV related including but not limited to, cardiac, pulmonary or hepatorenal disease that, in the opinion of the investigator, would compromise participation in the study

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: pregabalin
75mg BID, titrated up to 300mg according to individual response and tolerability

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Visual Analogue Scale (VAS) Pain Scores
Time Frame: Baseline, Week 4, Week 8, Week 12, and Endpoint

Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week.

Endpoint = last non-missing observation carried forward after Baseline visit.
Baseline, Week 4, Week 8, Week 12, and Endpoint

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.

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

February 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

December 12, 2005

First Submitted That Met QC Criteria

December 12, 2005

First Posted (Estimate)

December 13, 2005

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081095

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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