Prialt (Ziconotide) In Severe Chronic Pain

December 10, 2015 updated by: Elan Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

220

Phase

  • Phase 3

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
        • Tennesee Valley Pain Consultants - Center For Pain Management
      • Northport, Alabama, United States, 35476
        • The Pain Center
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Outcomes Research International
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • The RC Goodman Pain Institute: Clinical Research
      • Hot Springs, Arkansas, United States, 71913
        • Hot Springs Mercy Pain Clinic
      • Little Rock, Arkansas, United States, 72205
        • Innovative Spine Care
    • California
      • Bakersfield, California, United States, 93311
        • Advanced Pain Medicine
      • Duarte, California, United States, 91010
        • Advanced Pain Institute
      • La Jolla, California, United States, 92037
        • UCSD Medical Center, Thornton Hospital
      • Los Gatos, California, United States, 95032
        • Abaci and Massey Pain Center
      • San Francisco, California, United States, 94143-1654
        • UCSF Pain Management Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Pain Care Specialists
    • Florida
      • Tampa, Florida, United States, 33617
        • Clinical Pharmacology Services, Inc.
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Georgia Medical Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - St. Luke's Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky, Dept Anesthesiology
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Hospital, Division of Pain Management
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Arnold Pain Management
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Edina Medical Pain Center
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center - Pain Institute
    • Montana
      • Billings, Montana, United States, 59101
        • Yellowstone Medical Center East
    • New York
      • Huntington, New York, United States, 11743
        • Huntington Center for Pain Treatment
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
      • Syracuse, New York, United States, 13210
        • Medical Pain Management of Central NY
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Center for Clinical Research
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • Pain Institute of Tulsa
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pain Consultants of Oregon
      • Portland, Oregon, United States, 97232
        • Legacy Holladay Park Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State University Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Temple, Pennsylvania, United States, 19560
        • Advanced Clinical Concepts
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Neurosurgery Foundation
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC, Neurological Surgery
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist Comprehensive Pain Institute
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates, Inc.
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas M.D. Anderson Cancer Center
      • Lubbock, Texas, United States, 79430
        • Texas Tech University HSC
      • San Antonio, Texas, United States, 78217
        • Consultants in Pain Research
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Alpine Pain and Addiction Medicine
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Advanced Pain Management and Rehabilitation
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center - Pain Center
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Center for Pain Relief
    • Wisconsin
      • Cudahy, Wisconsin, United States, 53110
        • Cardinal Clinical Research Center

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:

  • Patient is able to read, understand, and voluntarily sign the Institutional Review Board (IRB) approved, written informed consent document prior to the performance of any 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 the Patient Daily Diary for Opioid Consumption;
  • Patient must have an implanted programmable SynchroMed® Infusion System in place for the treatment of chronic pain;
  • Female patients of childbearing age agree to use adequate, appropriate contraceptive methods.

Males and their partner(s) of childbearing age must use adequate, appropriate contraceptive methods.

Exclusion Criteria:

  • Patient is pregnant or lactating;
  • Patient has been on an investigational drug other than ziconotide or device within 30 days prior to the initiation of the study drug;
  • Patients with a known hypersensitivity (allergy) to ziconotide or any of the excipients (other compounds) in the formulation;
  • Patient has a condition that would contraindicate the use of IT analgesia, including the presence of infection at the microinfusion injection site (where the needle is inserted in your abdomen to fill the pump with medication), uncontrolled bleeding diathesis (tendency for bleeding) and spinal canal obstruction that impairs circulation of Cerebral Spinal Fluid.

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
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Collaborators and Investigators

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

Sponsor

Elan Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start

August 1, 2002

Study Completion

June 1, 2003

Study Registration Dates

First Submitted

October 16, 2002

First Submitted That Met QC Criteria

October 16, 2002

First Posted (Estimate)

October 17, 2002

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELN92045-301

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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