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Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy

NCT ID: NCT00232141

Last Updated: 2021-02-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-11-30

Brief Summary

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Study to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy.

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Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP

NCT00407511

Diabetic Peripheral Neuropathic Pain (DPN) Postherpetic Neuralgia (PHN) HIV-related Neuropathic Pain (HIV) +1 more
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Detailed Description

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Conditions

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HIV Infections Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

pregabalin

Intervention Type DRUG

75mg BID (can be titrated up to 150mg BID on day 4 based on individual response and up to 300mg BID at the end of week 1, visit 3 and end of week 2, visit 4)

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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pregabalin

75mg BID (can be titrated up to 150mg BID on day 4 based on individual response and up to 300mg BID at the end of week 1, visit 3 and end of week 2, visit 4)

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with confirmed diagnosis of HIV infection
* HIV-associated neuropathic pain (nerve pain) for at least 3 months prior to study start
* subjects with moderate to severe pain
* subjects on stable HIV and pain medications (some medications are not allowed to be taken while participating in the study).

Exclusion Criteria

* Pregnant or breast feeding females
* subjects using street drugs or alcohol abusers during the study
* subject's on anti-diabetic medications
* use of neuroregenerative agents or neurotoxic chemotherapeutic agents 3 months prior to study start and throughout the study
* use of neurotoxic drugs (other than D-drugs) within a month prior to study start and throughout 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

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Stanford, California, United States

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West Hollywood, California, United States

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Denver, Colorado, United States

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Miami, Florida, United States

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Pensacola, Florida, United States

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Safety Harbor, Florida, United States

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Vero Beach, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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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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St Louis, Missouri, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Longview, Texas, United States

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San Antonio, Texas, United States

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Seattle, Washington, United States

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Milwaukee, Wisconsin, 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

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Countries

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United States Puerto Rico

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081066&StudyName=Study%20of%20Pregabalin%20versus%20placebo%20in%20the%20treatment%20of%20Nerve%20Pain%20associated%20with%20HIV%20Neuropathy%20

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

Other Identifiers

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A0081066

Identifier Type: -

Identifier Source: org_study_id

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