drugset / Trial / NCT00286377
Safety and Efficacy Study of Prosaptide to Treat Neuropathic Pain in HIV-Positive Patients
Phase 2
Terminated
350 enrolled
Savient Pharmaceuticals
Neurologic AIDS Research Consortium (NARC) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a double-blind, placebo-controlled, parallel groups study to determine whether prosptide is effective in relieving pain in patients who have sensory neuropathic pain related to their HIV infection or the drugs used to treat it.
Timeline
- Start
- 2003-09
- Primary completion
- —
- Completion
- 2004-12
Outcome
Missed primary endpoint
paper CONCLUSIONS: 6-week treatment with PRO was safe but not effective at reducing HIV-associated neuropathic pain. PMID 17653259 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | prosaptide | Unknown | 2 mg | Subcutaneous |
| Subject | prosaptide | Unknown | 4 mg | Subcutaneous |
| Subject | prosaptide | Unknown | 8 mg | Subcutaneous |
| Subject | prosaptide | Unknown | 16 mg | Subcutaneous |