Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy
An Open-Label, Extension Safety And Efficacy Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With Human Immunodeficiency Virus (HIV) Neuropathy
1 other identifier
interventional
220
2 countries
37
Brief Summary
To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2006
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2005
CompletedFirst Posted
Study publicly available on registry
December 13, 2005
CompletedStudy Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
March 23, 2009
CompletedJanuary 22, 2021
October 1, 2018
2 years
December 12, 2005
February 20, 2009
January 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Participation in the preceding A0081066 double-blind trial met the entry criteria for that trial and completed A0081066 study through visit 7
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Pfizer Investigational Site
Phoenix, Arizona, 85023, United States
Pfizer Investigational Site
Little Rock, Arkansas, 72207, United States
Pfizer Investigational Site
Los Angeles, California, 90025, United States
Pfizer Investigational Site
Los Angeles, California, 90028, United States
Pfizer Investigational Site
Sacramento, California, 95817-1460, United States
Pfizer Investigational Site
San Diego, California, 92103, United States
Pfizer Investigational Site
San Francisco, California, 94117, United States
Pfizer Investigational Site
Stanford, California, 94305-5235, United States
Pfizer Investigational Site
West Hollywood, California, 90069, United States
Pfizer Investigational Site
Denver, Colorado, 80262, United States
Pfizer Investigational Site
Miami, Florida, 33133, United States
Pfizer Investigational Site
Pensacola, Florida, 32504-5719, United States
Pfizer Investigational Site
Safety Harbor, Florida, 34695, United States
Pfizer Investigational Site
Vero Beach, Florida, 32960, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33407, United States
Pfizer Investigational Site
Atlanta, Georgia, 30309, United States
Pfizer Investigational Site
Chicago, Illinois, 60611, United States
Pfizer Investigational Site
Chicago, Illinois, 60612, United States
Pfizer Investigational Site
Baltimore, Maryland, 21287-7609, United States
Pfizer Investigational Site
Boston, Massachusetts, 02215-3318, United States
Pfizer Investigational Site
Springfield, Massachusetts, 01107, United States
Pfizer Investigational Site
St Louis, Missouri, 63110-1010, United States
Pfizer Investigational Site
St Louis, Missouri, 63110, United States
Pfizer Investigational Site
New York, New York, 10018, United States
Pfizer Investigational Site
New York, New York, 10021, United States
Pfizer Investigational Site
New York, New York, 10029, United States
Pfizer Investigational Site
Rochester, New York, 14642, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Pfizer Investigational Site
Austin, Texas, 78705, United States
Pfizer Investigational Site
Dallas, Texas, 75204, United States
Pfizer Investigational Site
Dallas, Texas, 75208-4234, United States
Pfizer Investigational Site
Dallas, Texas, 75390-9036, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Seattle, Washington, 98104, United States
Pfizer Investigational Site
Ponce, 00716, Puerto Rico
Pfizer Investigational Site
San Juan, 00909-1711, Puerto Rico
Pfizer Investigational Site
San Juan, 00936, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2005
First Posted
December 13, 2005
Study Start
February 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
January 22, 2021
Results First Posted
March 23, 2009
Record last verified: 2018-10