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

This study has been completed.

Sponsored by: Neurex
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002160
  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 II

MedlinePlus related topics:   AIDS    Cancer   

ChemIDplus related topics:   Calcium gluconate    SNX 111   

U.S. FDA Resources

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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   100

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002160

Show 44 study locations  Show 44 Study Locations

Sponsors and Collaborators
Neurex
  More Information


Study ID Numbers:   256A
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002160
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

Study placed in the following topic categories:
Virus Diseases
Ziconotide
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Pain
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 16, 2008




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