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Safety and Efficacy Study of Prosaptide to Treat Neuropathic Pain in HIV-Positive Patients

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ClinicalTrials.gov Identifier: NCT00286377
Recruitment Status : Terminated
First Posted : February 3, 2006
Last Update Posted : February 3, 2006
Sponsor:
Collaborator:
Neurologic AIDS Research Consortium (NARC)
Information provided by:
Savient Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 30, 2005
First Posted Date  ICMJE February 3, 2006
Last Update Posted Date February 3, 2006
Study Start Date  ICMJE September 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2006)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2006)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Prosaptide to Treat Neuropathic Pain in HIV-Positive Patients
Official Title  ICMJE 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
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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • HIV
  • Peripheral Nervous System Disorders
Intervention  ICMJE Drug: prosaptide
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: February 2, 2006)
350
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages 18 years and older
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00286377
Other Study ID Numbers  ICMJE C0603
NARC # 009
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Savient Pharmaceuticals
Collaborators  ICMJE Neurologic AIDS Research Consortium (NARC)
Investigators  ICMJE
Study Director: Claudia Rehrig, MS Savient Pharmaceuticals, Inc.
PRS Account Savient Pharmaceuticals
Verification Date January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP