CTRI/2010/091/001319
Other
Phase 3
An Open-Label, Extension Safety Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With HIV Neuropathy - Not applicable
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pfizer Limited
- Enrollment
- 400
- Status
- Other
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects who participated in the preceding A0081244 double\-blind trial and completed at least through Visit 9 of that trial.
- •2\. Subjects with painful distal sensory polyneuropathy (DSP) interested in treatment based on investigator clinical judgment.
- •3\. Subjects who had acceptable tolerability of study drug in A0081244\.
- •Note: There is no upper age limit criteria per the protocol
Exclusion Criteria
- •1\.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.
- •2\.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.
- •3\.Active Acquired Immune Deficiency Syndrome (AIDS)\- defining Opportunistic Infection (OI) that requires hospitalization.
Outcomes
Primary Outcomes
Not specified
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