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NCT00002160 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002160
Other study ID # 256A
Secondary ID
Status Completed
Phase Phase 2
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date March 1998
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ziconotide

Locations
Country Name City State
United States Lehigh Valley Hosp Allentown Pennsylvania
United States Emory Univ Hosp Atlanta Georgia
United States Johns Hopkins Hosp Baltimore Maryland
United States Alta Bates Hosp Berkeley California
United States Brigham and Women's Hosp Boston Massachusetts
United States Cooper Hospital Early Intervention Program Camden New Jersey
United States Cook County Hosp Chicago Illinois
United States Pain Control Ctr Chicago Illinois
United States Cleveland Clinic Foundation Cleveland Ohio
United States Univ of Missouri Med Ctr Columbia Missouri
United States Connecticut Pain Care Danbury Connecticut
United States Elkhardt Gen Hosp Elkhardt Indiana
United States Fairfax Hosp Falls Church Virginia
United States Holt Krock Clinic Fort Smith Arkansas
United States Pain Diagnosis and Treatment Glendora California
United States Pennsylvania State College of Medicine Hershey Pennsylvania
United States Ctr for Pain Management and Rehabilitation Huntsville Alabama
United States Univ of Iowa Hosp Iowa City Iowa
United States The Pain Institute Kansas City Missouri
United States Univ of Kansas Med Ctr Kansas City Kansas
United States New Orleans Pharmaceutical Research Kenner Louisiana
United States Texas Tech Univ Health Science Ctr Lubbock Texas
United States Marschfield Clinic Marshfield Wisconsin
United States Methodist Hosp Memphis Tennessee
United States Univ of Tennessee Memphis Tennessee
United States Univ of Miami School of Medicine Miami Florida
United States Minneapolis Veterans Administration Minneapolis Minnesota
United States Gulf Coast Clinical Services Mobile Alabama
United States Pain Management New York New York
United States Northport Hosp Northport Alabama
United States Thomas Jefferson Univ Hosp Philadelphia Pennsylvania
United States Long Island Pain Management Port Jefferson Station New York
United States Clinical Solutions Princeton New Jersey
United States Univ of Rochester Rochester New York
United States Univ of Texas Health Sciences Ctr San Antonio Texas
United States Univ of CA - San Diego San Diego California
United States Good Samaritan Hosp Ctr San Jose California
United States Northwest Neuroscience Institute Seattle Washington
United States Swedish Pain Management Seattle Washington
United States Louisiana State Univ Shreveport Louisiana
United States H Lee Moffit Cancer Ctr and Research Institute Tampa Florida
United States Neurosurgical Associates Terre Haute Indiana
United States VA Med Ctr / Oncology Section Washington District of Columbia
United States Bowman Gray School of Medicine / Wake Forest Univ Winston Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Neurex

Country where clinical trial is conducted

United States, 

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