Phase 3
N=220
Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy
Peripheral Neuropathy · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00264875 ↗Enrolled (actual)
220
Serious AEs
—
Results posted
Mar 2009
Primary outcome: Primary: Mean Visual Analogue Scale (VAS) Pain Scores — 38.61; 30.75; 30.16; 28.95 score on scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pregabalin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Visual Analogue Scale (VAS) Pain Scores |
38.61; 30.75; 30.16; 28.95; 29.39 | — |
Summary
To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00264875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.