Pregabalin Trial In HIV Neuropathic Pain

Launched by PFIZER'S UPJOHN HAS MERGED WITH MYLAN TO FORM VIATRIS INC. · Jun 15, 2010

Keywords

ClinConnect Summary

The parent double blind study was stopped at interim analysis due to lack of efficacy and therefore this open label extension study was also terminated simultaneously on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects who participated in the preceding A0081244 double-blind trial and completed at least through Visit 9 of that trial.
• • Subjects with painful distal sensory polyneuropathy (DSP) interested in treatment based on investigator's clinical judgment.
• • Subjects who had acceptable tolerability of study drug in A0081244.
• Exclusion Criteria:
• • Clinically significant or unstable conditions that, in the opinion of the investigator, would compromise participation in the study. This includes, for example, medical conditions such as, but not limited to: hepatic, renal, respiratory, hematological, immunological, cardiovascular diseases, arrhythmia, inflammatory or rheumatologic disease, active infections, symptomatic peripheral vascular disease, psychiatric illness, and untreated endocrine disorders.
• • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• • Active Acquired Immune Deficiency Syndrome (AIDS)- defining Opportunistic Infection (OI) that requires hospitalization.