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

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Descriptive Information Fields
Brief Title ^†	A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
Official Title ^†	A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
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.
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Double-Blind, Safety Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections Cancer Pain
Intervention ^†	Drug: Ziconotide
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	100
Start Date ^†
Completion Date
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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00002160
Organization ID	256A
Secondary IDs ^††
Study Sponsor ^†	Neurex
Collaborators ^††
Investigators ^†
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	March 1998
First Received Date ^†	November 2, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.