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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 1999

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2001

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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