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.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00264875
First received: December 12, 2005
Last updated: March 20, 2009
Last verified: March 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72207
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90025
Pfizer Investigational Site
Los Angeles, California, United States, 90028
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
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80262
United States, Florida
Pfizer Investigational Site
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
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30309
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60612
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21287-7609
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215-3318
Pfizer Investigational Site
Springfield, Massachusetts, United States, 01107
United States, Missouri
Pfizer Investigational Site
Saint Louis, Missouri, United States, 63110-1010
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10018
Pfizer Investigational Site
New York, New York, United States, 10021
Pfizer Investigational Site
New York, New York, United States, 10029
Pfizer Investigational Site
Rochester, New York, United States, 14642
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Dallas, Texas, United States, 75208-4234
Pfizer Investigational Site
Dallas, Texas, United States, 75390-9036
Pfizer Investigational Site
Dallas, Texas, United States, 75204
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98104
Puerto Rico
Pfizer Investigational Site
Ponce, Puerto Rico, 00716
Pfizer Investigational Site
San Juan, Puerto Rico, 00909-1711
Pfizer Investigational Site
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Peripheral Nervous System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014