Prialt (Ziconotide) In Severe Chronic Pain

Last updated: December 10, 2015
Sponsor: Elan Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Pain

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT00047749
ELN92045-301
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to understand the effects of intrathecal ziconotide (an experimental pain medication) when the dose is slowly increased over a 3-week period in patients with severe chronic pain. During the weaning phase, the study will also gather information about switching from other intrathecal or IT medication (slowly pumped directly into the space around the spine) to other systemic pain medication (by mouth or through the skin using a patch). After being weaned off current IT medication, patients will be placed on IT ziconotide or placebo (non-active substance) as well as being allowed a stable dose of systemic pain medications.

Patients who complete this study may be eligible for long-term ziconotide therapy via extension protocol ELN92045-352.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is able to read, understand, and voluntarily sign the Institutional ReviewBoard (IRB) approved, written informed consent document prior to the performance ofany study-specific procedures;

  • Patient must be male or female at least 18 years of age;

  • Patient must have severe chronic pain for whom IT therapy is warranted;

  • Patient must be willing and able to comply with the protocol, and able to maintain thePatient Daily Diary for Opioid Consumption;

  • Patient must have an implanted programmable SynchroMed® Infusion System in place forthe treatment of chronic pain;

  • Female patients of childbearing age agree to use adequate, appropriate contraceptivemethods. Males and their partner(s) of childbearing age must use adequate, appropriate contraceptivemethods.

Exclusion

Exclusion Criteria:

  • Patient is pregnant or lactating;

  • Patient has been on an investigational drug other than ziconotide or device within 30days prior to the initiation of the study drug;

  • Patients with a known hypersensitivity (allergy) to ziconotide or any of theexcipients (other compounds) in the formulation;

  • Patient has a condition that would contraindicate the use of IT analgesia, includingthe presence of infection at the microinfusion injection site (where the needle isinserted in your abdomen to fill the pump with medication), uncontrolled bleedingdiathesis (tendency for bleeding) and spinal canal obstruction that impairscirculation of Cerebral Spinal Fluid.

Study Design

Total Participants: 220
Study Start date:
August 01, 2002
Estimated Completion Date:
June 30, 2003

Connect with a study center

  • Tennesee Valley Pain Consultants - Center For Pain Management

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • The Pain Center

    Northport, Alabama 35476
    United States

    Site Not Available

  • Outcomes Research International

    Tucson, Arizona 85711
    United States

    Site Not Available

  • The RC Goodman Pain Institute: Clinical Research

    Fort Smith, Arkansas 72901
    United States

    Site Not Available

  • Hot Springs Mercy Pain Clinic

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Innovative Spine Care

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Advanced Pain Medicine

    Bakersfield, California 93311
    United States

    Site Not Available

  • Advanced Pain Institute

    Duarte, California 91010
    United States

    Site Not Available

  • UCSD Medical Center, Thornton Hospital

    La Jolla, California 92037
    United States

    Site Not Available

  • Abaci and Massey Pain Center

    Los Gatos, California 95032
    United States

    Site Not Available

  • UCSF Pain Management Center

    San Francisco, California 94143-1654
    United States

    Site Not Available

  • Pain Care Specialists

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Clinical Pharmacology Services, Inc.

    Tampa, Florida 33617
    United States

    Site Not Available

  • Georgia Medical Research Institute

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Rush Presbyterian - St. Luke's Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Kentucky, Dept Anesthesiology

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Johns Hopkins Hospital, Division of Pain Management

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Arnold Pain Management

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Edina Medical Pain Center

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Research Medical Center - Pain Institute

    Kansas City, Missouri 64132
    United States

    Site Not Available

  • Yellowstone Medical Center East

    Billings, Montana 59101
    United States

    Site Not Available

  • Huntington Center for Pain Treatment

    Huntington, New York 11743
    United States

    Site Not Available

  • Weill Medical College of Cornell University

    New York, New York 10021
    United States

    Site Not Available

  • Medical Pain Management of Central NY

    Syracuse, New York 13210
    United States

    Site Not Available

  • Center For Clinical Research

    Winston Salem, North Carolina 27103
    United States

    Site Not Available

  • Center For Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Pain Institute of Tulsa

    Tulsa, Oklahoma 74137
    United States

    Site Not Available

  • Pain Consultants of Oregon

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Legacy Holladay Park Medical Center

    Portland, Oregon 97232
    United States

    Site Not Available

  • Penn State University Hospital

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Advanced Clinical Concepts

    Temple, Pennsylvania 19560
    United States

    Site Not Available

  • Neurosurgery Foundation

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • MUSC, Neurological Surgery

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Methodist Comprehensive Pain Institute

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • Clinical Research Associates, Inc.

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Tech University HSC

    Lubbock, Texas 79430
    United States

    Site Not Available

  • Consultants in Pain Research

    San Antonio, Texas 78217
    United States

    Site Not Available

  • Alpine Pain and Addiction Medicine

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Advanced Pain Management and Rehabilitation

    Virginia Beach, Virginia 23454
    United States

    Site Not Available

  • University of Washington Medical Center - Pain Center

    Seattle, Washington 98195
    United States

    Site Not Available

  • Center for Pain Relief

    Charleston, West Virginia 25301
    United States

    Site Not Available

  • Cardinal Clinical Research Center

    Cudahy, Wisconsin 53110
    United States

    Site Not Available

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