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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

NCT ID: NCT00002160

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Brief Summary

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To determine the safety and efficacy of SNX-111 in controlling severe, chronic pain in cancer and AIDS patients.

Detailed Description

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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.

Conditions

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HIV Infections Cancer Pain

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ziconotide

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurex

INDUSTRY

Sponsor Role lead

Locations

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Ctr for Pain Management and Rehabilitation

Huntsville, Alabama, United States

Site Status

Gulf Coast Clinical Services

Mobile, Alabama, United States

Site Status

Northport Hosp

Northport, Alabama, United States

Site Status

Holt Krock Clinic

Fort Smith, Arkansas, United States

Site Status

Alta Bates Hosp

Berkeley, California, United States

Site Status

Pain Diagnosis and Treatment

Glendora, California, United States

Site Status

Univ of CA - San Diego

San Diego, California, United States

Site Status

Good Samaritan Hosp Ctr

San Jose, California, United States

Site Status

Connecticut Pain Care

Danbury, Connecticut, United States

Site Status

VA Med Ctr / Oncology Section

Washington D.C., District of Columbia, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

H Lee Moffit Cancer Ctr and Research Institute

Tampa, Florida, United States

Site Status

Emory Univ Hosp

Atlanta, Georgia, United States

Site Status

Cook County Hosp

Chicago, Illinois, United States

Site Status

Pain Control Ctr

Chicago, Illinois, United States

Site Status

Elkhardt Gen Hosp

Elkhardt, Indiana, United States

Site Status

Neurosurgical Associates

Terre Haute, Indiana, United States

Site Status

Univ of Iowa Hosp

Iowa City, Iowa, United States

Site Status

Univ of Kansas Med Ctr

Kansas City, Kansas, United States

Site Status

New Orleans Pharmaceutical Research

Kenner, Louisiana, United States

Site Status

Louisiana State Univ

Shreveport, Louisiana, United States

Site Status

Johns Hopkins Hosp

Baltimore, Maryland, United States

Site Status

Brigham and Women's Hosp

Boston, Massachusetts, United States

Site Status

Minneapolis Veterans Administration

Minneapolis, Minnesota, United States

Site Status

Univ of Missouri Med Ctr

Columbia, Missouri, United States

Site Status

The Pain Institute

Kansas City, Missouri, United States

Site Status

Cooper Hospital Early Intervention Program

Camden, New Jersey, United States

Site Status

Clinical Solutions

Princeton, New Jersey, United States

Site Status

Pain Management

New York, New York, United States

Site Status

Long Island Pain Management

Port Jefferson Station, New York, United States

Site Status

Univ of Rochester

Rochester, New York, United States

Site Status

Bowman Gray School of Medicine / Wake Forest Univ

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Lehigh Valley Hosp

Allentown, Pennsylvania, United States

Site Status

Pennsylvania State College of Medicine

Hershey, Pennsylvania, United States

Site Status

Thomas Jefferson Univ Hosp

Philadelphia, Pennsylvania, United States

Site Status

Methodist Hosp

Memphis, Tennessee, United States

Site Status

Univ of Tennessee

Memphis, Tennessee, United States

Site Status

Texas Tech Univ Health Science Ctr

Lubbock, Texas, United States

Site Status

Univ of Texas Health Sciences Ctr

San Antonio, Texas, United States

Site Status

Fairfax Hosp

Falls Church, Virginia, United States

Site Status

Swedish Pain Management

Seattle, Washington, United States

Site Status

Northwest Neuroscience Institute

Seattle, Washington, United States

Site Status

Marschfield Clinic

Marshfield, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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256A

Identifier Type: -

Identifier Source: org_study_id