A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations
Show 44 Study Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002160 History of Changes |
| Other Study ID Numbers: | 256A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Acquired Immunodeficiency Syndrome AIDS-Related Complex Pain |
Palliative Care omega-conopeptide MVIIA Calcium Channel Blockers |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Calcium Channel Blockers Ziconotide |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Neuroprotective Agents Protective Agents Physiological Effects of Drugs Central Nervous System Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013