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

This study has been completed.

First Received: December 12, 2005 Last Updated: March 20, 2009 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00264875

Purpose

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

Condition	Intervention	Phase
Peripheral Neuropathy HIV Infections	Drug: pregabalin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Extension Safety And Efficacy Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With Human Immunodeficiency Virus (HIV) Neuropathy

Resource links provided by NLM:

MedlinePlus related topics: AIDS Peripheral Nerve Disorders

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Mean Visual Analogue Scale (VAS) Pain Scores [ Time Frame: Baseline, Week 4, Week 8, Week 12, and Endpoint ] [ Designated as safety issue: No ]

Enrollment:	220
Study Start Date:	February 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: pregabalin 75mg BID, titrated up to 300mg according to individual response and tolerability

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264875

Show 37 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081095
Study First Received:	December 12, 2005
Results First Received:	February 20, 2009
Last Updated:	March 20, 2009
ClinicalTrials.gov Identifier:	NCT00264875 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Pregabalin
Pain
Immunologic Deficiency Syndromes
Virus Diseases
Neuromuscular Diseases

HIV Infections
Peripheral Nervous System Diseases
Sexually Transmitted Diseases
Analgesics
Peripheral Nervous System Agents
Retroviridae Infections
Anticonvulsants

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Physiological Effects of Drugs
Nervous System Diseases
Acquired Immunodeficiency Syndrome
Pregabalin
Infection
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases

Neuromuscular Diseases
Sensory System Agents
HIV Infections
Therapeutic Uses
Peripheral Nervous System Diseases
Sexually Transmitted Diseases
Lentivirus Infections
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Retroviridae Infections
Anticonvulsants

ClinicalTrials.gov processed this record on August 30, 2009