Status:
COMPLETED
Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Peripheral Neuropathy
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy
Eligibility Criteria
Inclusion
- Participation in the preceding A0081066 double-blind trial met the entry criteria for that trial and completed A0081066 study through visit 7
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00264875
Start Date
February 1 2006
End Date
February 1 2008
Last Update
January 22 2021
Active Locations (37)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023
2
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72207
3
Pfizer Investigational Site
Los Angeles, California, United States, 90025
4
Pfizer Investigational Site
Los Angeles, California, United States, 90028