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

June 23, 2005 updated by: Neurex
To determine the safety and efficacy of SNX-111 in controlling severe, chronic pain in cancer and AIDS patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Ctr for Pain Management and Rehabilitation
      • Mobile, Alabama, United States, 36603
        • Gulf Coast Clinical Services
      • Northport, Alabama, United States, 35476
        • Northport Hosp
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Holt Krock Clinic
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Hosp
      • Glendora, California, United States, 917414240
        • Pain Diagnosis and Treatment
      • San Diego, California, United States, 921038770
        • Univ of CA - San Diego
      • San Jose, California, United States, 95124
        • Good Samaritan Hosp Ctr
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Connecticut Pain Care
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • VA Med Ctr / Oncology Section
    • Florida
      • Miami, Florida, United States, 33136
        • Univ of Miami School of Medicine
      • Tampa, Florida, United States, 33612
        • H Lee Moffit Cancer Ctr and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Univ Hosp
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp
      • Chicago, Illinois, United States, 60612
        • Pain Control Ctr
    • Indiana
      • Elkhardt, Indiana, United States, 46514
        • Elkhardt Gen Hosp
      • Terre Haute, Indiana, United States, 47804
        • Neurosurgical Associates
    • Iowa
      • Iowa City, Iowa, United States, 522421061
        • Univ of Iowa Hosp
    • Kansas
      • Kansas City, Kansas, United States, 661607415
        • Univ of Kansas Med Ctr
    • Louisiana
      • Kenner, Louisiana, United States, 70062
        • New Orleans Pharmaceutical Research
      • Shreveport, Louisiana, United States, 711303932
        • Louisiana State Univ
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Hosp
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hosp
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis Veterans Administration
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Univ of Missouri Med Ctr
      • Kansas City, Missouri, United States, 64132
        • The Pain Institute
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital Early Intervention Program
      • Princeton, New Jersey, United States, 08540
        • Clinical Solutions
    • New York
      • New York, New York, United States, 10021
        • Pain Management
      • Port Jefferson Station, New York, United States, 11776
        • Long Island Pain Management
      • Rochester, New York, United States, 14642
        • Univ of Rochester
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
        • Bowman Gray School of Medicine / Wake Forest Univ
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Lehigh Valley Hosp
      • Hershey, Pennsylvania, United States, 17033
        • Pennsylvania State College of Medicine
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Univ Hosp
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Univ of Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist Hosp
    • Texas
      • Lubbock, Texas, United States, 79430
        • Texas Tech Univ Health Science Ctr
      • San Antonio, Texas, United States, 782847838
        • Univ of Texas Health Sciences Ctr
    • Virginia
      • Falls Church, Virginia, United States, 220423300
        • Fairfax Hosp
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Pain Management
      • Seattle, Washington, United States, 98133
        • Northwest Neuroscience Institute
    • Wisconsin
      • Marshfield, Wisconsin, United States, 544495777
        • Marschfield Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 256A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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