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

NCT ID: NCT00264875

Last Updated: 2021-01-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-02-29

Brief Summary

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

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A Study of the Efficacy and Safety of Pregabalin for the Treatment of Diabetic Peripheral Neuropathy or Postherpetic Neuralgia

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Detailed Description

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Conditions

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Peripheral Neuropathy HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

pregabalin

Intervention Type DRUG

75mg BID, titrated up to 300mg according to individual response and tolerability

Interventions

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pregabalin

75mg BID, titrated up to 300mg according to individual response and tolerability

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

Little Rock, Arkansas, United States

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Pfizer Investigational Site

Los Angeles, California, United States

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Pfizer Investigational Site

Los Angeles, California, United States

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Pfizer Investigational Site

Sacramento, California, United States

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Pfizer Investigational Site

San Diego, California, United States

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Pfizer Investigational Site

San Francisco, California, United States

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Pfizer Investigational Site

Stanford, California, United States

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Pfizer Investigational Site

West Hollywood, California, United States

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Pfizer Investigational Site

Denver, Colorado, United States

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Miami, Florida, United States

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Pensacola, Florida, United States

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Pfizer Investigational Site

Safety Harbor, Florida, United States

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Pfizer Investigational Site

Vero Beach, Florida, United States

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Pfizer Investigational Site

West Palm Beach, Florida, United States

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Pfizer Investigational Site

Atlanta, Georgia, United States

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Pfizer Investigational Site

Chicago, Illinois, United States

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Pfizer Investigational Site

Chicago, Illinois, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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St Louis, Missouri, United States

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Pfizer Investigational Site

St Louis, Missouri, United States

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Pfizer Investigational Site

New York, New York, United States

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Pfizer Investigational Site

New York, New York, United States

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Pfizer Investigational Site

New York, New York, United States

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Pfizer Investigational Site

Rochester, New York, United States

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Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

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Pfizer Investigational Site

Austin, Texas, United States

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Pfizer Investigational Site

Dallas, Texas, United States

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Pfizer Investigational Site

Dallas, Texas, United States

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Pfizer Investigational Site

Dallas, Texas, United States

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Pfizer Investigational Site

San Antonio, Texas, United States

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Pfizer Investigational Site

Seattle, Washington, United States

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Pfizer Investigational Site

Ponce, , Puerto Rico

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Pfizer Investigational Site

San Juan, , Puerto Rico

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Pfizer Investigational Site

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081095&StudyName=Open%20Label%20Safety%20And%20Efficacy%20Study%20Of%20Pregabalin%20In%20Subjects%20With%20Nerve%20Pain%20Asociated%20With%20HIV%20Neuropathy

To obtain contact information for a study center near you, click here.

Other Identifiers

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A0081095

Identifier Type: -

Identifier Source: org_study_id

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