A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
- Conditions
- HIV InfectionsCancerPain
- Registration Number
- NCT00002160
- Lead Sponsor
- Neurex
- Brief Summary
To determine the safety and efficacy of SNX-111 in controlling severe, chronic pain in cancer and AIDS patients.
- Detailed Description
Patients are randomized to receive SNX-111 or placebo (AS PER AMENDMENT 1/22/98: with randomization weighted 2:1 in favor of SNX-111) via external pump and an intrathecal catheter (thin tube inserted into the spinal canal). (AS PER AMENDMENT 1/22/98: the dose is increased every 24 hours, in the absence of onset of analgesia or adverse events. After 2-5 days, patients who respond to their medication continue treatment at home for 5-8 days. Patients who do not respond will be switched to the other regimen (i.e., placebo to SNX-111, or SNX-111 to placebo). After 10 days, responding patients are unblinded and asked to enroll in the long-term, open-label extension protocol. Patients remain on a fixed dose at the therapeutic level found in the previous study. The dose may be increased or decreased at the discretion of the investigator. Patients may continue therapy on a long-term basis until the drug is approved.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
Ctr for Pain Management and Rehabilitation
🇺🇸Huntsville, Alabama, United States
Gulf Coast Clinical Services
🇺🇸Mobile, Alabama, United States
Northport Hosp
🇺🇸Northport, Alabama, United States
Holt Krock Clinic
🇺🇸Fort Smith, Arkansas, United States
Alta Bates Hosp
🇺🇸Berkeley, California, United States
Pain Diagnosis and Treatment
🇺🇸Glendora, California, United States
Univ of CA - San Diego
🇺🇸San Diego, California, United States
Good Samaritan Hosp Ctr
🇺🇸San Jose, California, United States
Connecticut Pain Care
🇺🇸Danbury, Connecticut, United States
VA Med Ctr / Oncology Section
🇺🇸Washington, District of Columbia, United States
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