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)
Emory Univ Hosp
🇺🇸Atlanta, Georgia, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Thomas Jefferson Univ Hosp
🇺🇸Philadelphia, Pennsylvania, United States
Swedish Pain Management
🇺🇸Seattle, Washington, United States
Northwest Neuroscience Institute
🇺🇸Seattle, Washington, United States
Northport Hosp
🇺🇸Northport, Alabama, United States
VA Med Ctr / Oncology Section
🇺🇸Washington, District of Columbia, United States
Univ of CA - San Diego
🇺🇸San Diego, California, United States
Neurosurgical Associates
🇺🇸Terre Haute, Indiana, United States
Long Island Pain Management
🇺🇸Port Jefferson Station, New York, United States
Elkhardt Gen Hosp
🇺🇸Elkhardt, Indiana, United States
Connecticut Pain Care
🇺🇸Danbury, Connecticut, United States
Univ of Missouri Med Ctr
🇺🇸Columbia, Missouri, United States
H Lee Moffit Cancer Ctr and Research Institute
🇺🇸Tampa, Florida, United States
Holt Krock Clinic
🇺🇸Fort Smith, Arkansas, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Pain Management
🇺🇸New York, New York, United States
Brigham and Women's Hosp
🇺🇸Boston, Massachusetts, United States
Pain Diagnosis and Treatment
🇺🇸Glendora, California, United States
Minneapolis Veterans Administration
🇺🇸Minneapolis, Minnesota, United States
Good Samaritan Hosp Ctr
🇺🇸San Jose, California, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Cooper Hospital Early Intervention Program
🇺🇸Camden, New Jersey, United States
Marschfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Pennsylvania State College of Medicine
🇺🇸Hershey, Pennsylvania, United States
Univ of Kansas Med Ctr
🇺🇸Kansas City, Kansas, United States
Gulf Coast Clinical Services
🇺🇸Mobile, Alabama, United States
The Pain Institute
🇺🇸Kansas City, Missouri, United States
Pain Control Ctr
🇺🇸Chicago, Illinois, United States
Bowman Gray School of Medicine / Wake Forest Univ
🇺🇸Winston Salem, North Carolina, United States
Lehigh Valley Hosp
🇺🇸Allentown, Pennsylvania, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Alta Bates Hosp
🇺🇸Berkeley, California, United States
Ctr for Pain Management and Rehabilitation
🇺🇸Huntsville, Alabama, United States
Univ of Iowa Hosp
🇺🇸Iowa City, Iowa, United States
Univ of Rochester
🇺🇸Rochester, New York, United States
Methodist Hosp
🇺🇸Memphis, Tennessee, United States
Texas Tech Univ Health Science Ctr
🇺🇸Lubbock, Texas, United States
Fairfax Hosp
🇺🇸Falls Church, Virginia, United States
Univ of Texas Health Sciences Ctr
🇺🇸San Antonio, Texas, United States
Clinical Solutions
🇺🇸Princeton, New Jersey, United States
Louisiana State Univ
🇺🇸Shreveport, Louisiana, United States
Univ of Tennessee
🇺🇸Memphis, Tennessee, United States
New Orleans Pharmaceutical Research
🇺🇸Kenner, Louisiana, United States