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NCT00264875 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00264875
Other study ID # A0081095
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2006
Est. completion date February 2008

Study information
Verified date October 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• pregabalin
75mg BID, titrated up to 300mg according to individual response and tolerability

Locations
Country Name City State
Puerto Rico Pfizer Investigational Site Ponce
Puerto Rico Pfizer Investigational Site San Juan
Puerto Rico Pfizer Investigational Site San Juan
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Pensacola Florida
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Sacramento California
United States Pfizer Investigational Site Safety Harbor Florida
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Francisco California
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Springfield Massachusetts
United States Pfizer Investigational Site Stanford California
United States Pfizer Investigational Site Vero Beach Florida
United States Pfizer Investigational Site West Hollywood California
United States Pfizer Investigational Site West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Visual Analogue Scale (VAS) Pain Scores 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
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