Safety and Efficacy Study of Prosaptide to Treat Neuropathic Pain in HIV-Positive Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00286377|
Recruitment Status : Terminated
First Posted : February 3, 2006
Last Update Posted : February 3, 2006
|Condition or disease||Intervention/treatment||Phase|
|HIV Peripheral Nervous System Disorders||Drug: prosaptide||Phase 2|
Sensory neruopathies are the most frequent neurological complicaton of HIV infection and its treatmet with antiretrovirals. To date, there are few effective treatments, and all are symptomatic treatments for pain. Management typically involves the intiation and adjustment of pain-modifying therapies, and the adjustment or discontinuation of potentially neurotoxic antiretrovirals, thereby limiting the choice of HAART regimens.
In precinical animal models,prosaptide has been shown to be efficacious in the treatment of neuropathic pain caused by a variety of different mechanisms.
Hypothesis: Prosaptide will improve neuropathic pain in HIV-associated sensory neuroathies,and will be safe and well tolerated in subjects.
Comparisons: 4, 8, or 16 mg prosaptide vs. placebo
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of Prosaptide Over 6 Weeks of Treatment for the Relief of Neuropathic Pain Associated With HIV-1|
|Study Start Date :||September 2003|
|Estimated Study Completion Date :||December 2004|
- Differnece between the pain rating at Baseline vs. Week 6 (or last week)of treatment, based on the 13-point Gracely pain intensity scale as rated by subjects and captured in an electronic diary
- Difference between the Beline pain rating and each week of treatment.
- Number of subjects whoe were treatment successes at each week of the active treatment period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286377
|Study Director:||Claudia Rehrig, MS||Savient Pharmaceuticals, Inc.|