DRUG
A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
Status
Completed
Phase
Phase 2
Enrollment
100
Locations
44
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
To determine the safety and efficacy of SNX-111 in controlling severe, chronic pain in cancer and AIDS patients.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 31, 2001
Study start
Not reported
Primary completion
Not reported
Study completion
Not reported
Results posted
Not reported
Registry updated
Jun 24, 2005
Outcomes
What the study measures.
Primary outcomes
Not reported in the indexed record.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria Concurrent Medication: Allowed: * Rescue analgesia. Patients must have: * Chronic pain related to AIDS or cancer. * Unsatisfactory response to prior opioid therapy. * Life expectancy \> 3 months (or 1 month if an infusion pump is in place). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Signs of sepsis or inadequately treated infection. Patients with the following prior conditions are excluded: History of heart disease, heart failure, or asthma.
Study locations
44 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
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 D.C., District of Columbia, United States
Univ of Miami School of Medicine
Miami, Florida, United States
H Lee Moffit Cancer Ctr and Research Institute
Tampa, Florida, United States
Emory Univ Hosp
Atlanta, Georgia, United States
Cook County Hosp
Chicago, Illinois, United States
Pain Control Ctr
Chicago, Illinois, United States
Elkhardt Gen Hosp
Elkhardt, Indiana, United States
Neurosurgical Associates
Terre Haute, Indiana, United States
Univ of Iowa Hosp
Iowa City, Iowa, United States
Univ of Kansas Med Ctr
Kansas City, Kansas, United States
New Orleans Pharmaceutical Research
Kenner, Louisiana, United States
Louisiana State Univ
Shreveport, Louisiana, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Brigham and Women's Hosp
Boston, Massachusetts, United States
Minneapolis Veterans Administration
Minneapolis, Minnesota, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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