Safety and Efficacy Study of Prosaptide to Treat Neuropathic Pain in HIV-Positive Patients
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
2 other identifiers
interventional
350
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv
Started Sep 2003
Shorter than P25 for phase_2 hiv
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
February 3, 2006
CompletedFebruary 3, 2006
January 1, 2006
June 30, 2005
February 2, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Ages 18 years and older
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Evans SR, Simpson DM, Kitch DW, King A, Clifford DB, Cohen BA, McArthur JC; Neurologic AIDS Research Consortium; AIDS Clinical Trials Group. A randomized trial evaluating Prosaptide for HIV-associated sensory neuropathies: use of an electronic diary to record neuropathic pain. PLoS One. 2007 Jul 25;2(6):e551. doi: 10.1371/journal.pone.0000551.
PMID: 17653259DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Claudia Rehrig, MS
Savient Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 30, 2005
First Posted
February 3, 2006
Study Start
September 1, 2003
Study Completion
December 1, 2004
Last Updated
February 3, 2006
Record last verified: 2006-01