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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 |
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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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Pain |
Palliative Care omega-conopeptide MVIIA Calcium Channel Blockers |
Ziconotide Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Calcium Channel Blockers AIDS-Related Complex Pain Cardiovascular Agents Neuroprotective Agents Immunologic Deficiency Syndromes |
Virus Diseases Calcium, Dietary Analgesics, Non-Narcotic HIV Infections Sexually Transmitted Diseases Peripheral Nervous System Agents Analgesics Retroviridae Infections |
Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Calcium Channel Blockers Infection Neuroprotective Agents Membrane Transport Modulators Sensory System Agents Therapeutic Uses Analgesics Retroviridae Infections Ziconotide RNA Virus Infections |
Immune System Diseases Acquired Immunodeficiency Syndrome Cardiovascular Agents Protective Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Analgesics, Non-Narcotic Sexually Transmitted Diseases Lentivirus Infections Peripheral Nervous System Agents Central Nervous System Agents |