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Sponsored by: |
Neurex |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002160 |
To determine the safety and efficacy of SNX-111 in controlling severe, chronic pain in cancer and AIDS patients.
Condition | Intervention | Phase |
---|---|---|
HIV Infections Cancer Pain |
Drug: Ziconotide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain |
Estimated Enrollment: | 100 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
History of heart disease, heart failure, or asthma.
Study ID Numbers: | 256A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002160 |
Health Authority: | United States: Food and Drug Administration |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Pain |
Palliative Care omega-conopeptide MVIIA Calcium Channel Blockers |
Virus Diseases Calcium, Dietary Ziconotide Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Pain AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Calcium Channel Blockers Cardiovascular Agents Infection Neuroprotective Agents Protective Agents |
Pharmacologic Actions Membrane Transport Modulators Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Lentivirus Infections Peripheral Nervous System Agents Analgesics Central Nervous System Agents |