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Prialt (Ziconotide) In Severe Chronic Pain
This study has been completed.
First Received: October 16, 2002   Last Updated: June 23, 2005   History of Changes
Sponsor: Elan Pharmaceuticals
Information provided by: Elan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00047749
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Prialt (ziconotide)
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain

Resource links provided by NLM:


Further study details as provided by Elan Pharmaceuticals:

Estimated Enrollment: 220
Study Start Date: August 2002
Estimated Study Completion Date: June 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047749

  Hide Study Locations
Locations
United States, Alabama
Tennesee Valley Pain Consultants - Center For Pain Management
Huntsville, Alabama, United States, 35801
The Pain Center
Northport, Alabama, United States, 35476
United States, Arizona
Outcomes Research International
Tucson, Arizona, United States, 85711
United States, Arkansas
Hot Springs Mercy Pain Clinic
Hot Springs, Arkansas, United States, 71913
Innovative Spine Care
Little Rock, Arkansas, United States, 72205
The RC Goodman Pain Institute: Clinical Research
Fort Smith, Arkansas, United States, 72901
United States, California
Advanced Pain Medicine
Bakersfield, California, United States, 93311
Abaci and Massey Pain Center
Los Gatos, California, United States, 95032
Advanced Pain Institute
Duarte, California, United States, 91010
UCSF Pain Management Center
San Francisco, California, United States, 94143-1654
UCSD Medical Center, Thornton Hospital
La Jolla, California, United States, 92037
United States, Colorado
Pain Care Specialists
Colorado Springs, Colorado, United States, 80907
United States, Florida
Clinical Pharmacology Services, Inc.
Tampa, Florida, United States, 33617
United States, Georgia
Georgia Medical Research Institute
Marietta, Georgia, United States, 30060
United States, Illinois
Rush Presbyterian - St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Kentucky
University of Kentucky, Dept Anesthesiology
Lexington, Kentucky, United States, 40536
United States, Maryland
Johns Hopkins Hospital, Division of Pain Management
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Arnold Pain Management
Boston, Massachusetts, United States, 02215
United States, Minnesota
Edina Medical Pain Center
Edina, Minnesota, United States, 55435
United States, Missouri
Research Medical Center - Pain Institute
Kansas City, Missouri, United States, 64132
United States, Montana
Yellowstone Medical Center East
Billings, Montana, United States, 59101
United States, New York
Huntington Center for Pain Treatment
Huntington, New York, United States, 11743
Medical Pain Management of Central NY
Syracuse, New York, United States, 13210
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, North Carolina
Center For Clinical Research
Winston Salem, North Carolina, United States, 27103
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Pain Institute of Tulsa
Tulsa, Oklahoma, United States, 74137
United States, Oregon
Pain Consultants of Oregon
Eugene, Oregon, United States, 97401
Legacy Holladay Park Medical Center
Portland, Oregon, United States, 97232
United States, Pennsylvania
Penn State University Hospital
Hershey, Pennsylvania, United States, 17033
Advanced Clinical Concepts
Temple, Pennsylvania, United States, 19560
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
Neurosurgery Foundation
Providence, Rhode Island, United States, 02903
United States, South Carolina
MUSC, Neurological Surgery
Charleston, South Carolina, United States, 29425
United States, Tennessee
Methodist Comprehensive Pain Institute
Memphis, Tennessee, United States, 38104
Clinical Research Associates, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Texas Tech University HSC
Lubbock, Texas, United States, 79430
Consultants in Pain Research
San Antonio, Texas, United States, 78217
United States, Utah
Alpine Pain and Addiction Medicine
Salt Lake City, Utah, United States, 84107
United States, Virginia
Advanced Pain Management and Rehabilitation
Virginia Beach, Virginia, United States, 23454
United States, Washington
University of Washington Medical Center - Pain Center
Seattle, Washington, United States, 98195
United States, West Virginia
Center for Pain Relief
Charleston, West Virginia, United States, 25301
United States, Wisconsin
Cardinal Clinical Research Center
Cudahy, Wisconsin, United States, 53110
Sponsors and Collaborators
Elan Pharmaceuticals
  More Information

Additional Information:
No publications provided

Study ID Numbers: ELN92045-301
Study First Received: October 16, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00047749     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:
pain
ziconotide
Prialt
intrathecal
Synchromed

Additional relevant MeSH terms:
Ziconotide
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Calcium Channel Blockers
Cardiovascular Agents
Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Membrane Transport Modulators
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009