A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain

Launched by NEUREX · Aug 30, 2001

Keywords

ClinConnect Summary

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 ar...

Gender

ALL

Eligibility criteria

• • 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.