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Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain
This study has been completed.
First Received: January 26, 2004   Last Updated: February 18, 2009   History of Changes
Sponsor: Elan Pharmaceuticals
Information provided by: Elan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00076544
  Purpose

The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.


Condition Intervention Phase
Pain
Drug: Ziconotide
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study
Official Title: An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain

Resource links provided by NLM:


Further study details as provided by Elan Pharmaceuticals:

Estimated Enrollment: 300
Study Start Date: February 2004
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Each patient must have chronic severe pain of malignant or nonmalignant etiology with inadequate pain relief from or intolerance to conventional therapy.
  • Each patient must have a predicted life expectancy of greater than or equal to 6 weeks relative to baseline.
  • Each patient must be able to respond to the Visual Analog Scale of Pain Intensity (VASPI).
  • Each patient must have an implanted programmable SynchroMed infusion device or a CADD-Micro external programmable infusion device and spinal catheter (hereafter "IT pump and spinal catheter") prior to enrollment into this trial. (If a patient has an external pump, the Investigator must ensure that the patient is at a low risk for infection and that the patient is capable of maintaining good personal hygiene. The Investigator must have demonstrated the ability to successfully manage patients with external pumps prior to enrolling a patient in this trial.)
  • Each patient must be at least 18 years of age.
  • Each patient must be competent to give written informed consent and has given written informed consent prior to performance of any study-related procedures. Reasonable accommodation of visually impaired patients will be allowed.
  • Each patient is willing and able to comply with the protocol requirements.
  • Each female patient of childbearing potential must agree to use adequate contraceptive methods while on PRIALT as determined by the Investigator.

Exclusion Criteria:

  • Presence of pregnancy or lactation.
  • Participation in another investigational drug or device trial within the preceding 30 days.
  • Presence of known hypersensitivity to PRIALT or any of its components.
  • Presence of any contraindication to continued IT therapy (for example, infection at the pump or catheter externalization site, uncontrolled bleeding diathesis, spinal canal obstruction that impairs cerebrospinal fluid [CSF] circulation, or patient and caregiver inability to manage and protect the IT pump and spinal catheter system and return for clinic follow up visits).
  • Presence of any condition (for example, psychosis, severe depression or suicidal ideation, homicidality, somatization disorder, active substance abuse, cognitive deficits, dementia or other serious medical or psychiatric condition) that in the Investigator's opinion precludes the patient's ability to participate in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076544

  Hide Study Locations
Locations
United States, Alabama
Alabama Pain Center
Huntsville, Alabama, United States, 35801
Center for Pain Management
Huntsville, Alabama, United States, 35801
United States, Arizona
Outcomes Research International
Tucson, Arizona, United States, 85712
Otto Uhrik, MD
Sun City West, Arizona, United States, 85373
United States, Arkansas
Innovative Spine Care
Little Rock, Arkansas, United States, 72205
The RC Goodman Pain Institute
Fort Smith, Arkansas, United States, 72901
United States, California
Bay Area Pain Center
Los Gatos, California, United States, 95032
Galileo Surgery Center
San Luis Obispo, California, United States, 93405
Pacific Pain Treatment Centers
San Francisco, California, United States, 94109
Shreenath Clinical Services
Long Beach, California, United States, 90807
Shreenath Clinical Services
Lake Forest, California, United States, 92630
Shreenath Clinical Services
Beverly Hills, California, United States, 90211
Advanced Pain Institute
Duarte, California, United States, 91010
Pacific Pain Medicine Consultants
Oceanside, California, United States, 92056
Northridge Surgery & Pain Management Center
Northridge, California, United States, 91324
United States, Colorado
Rocky Mountain Clinical Research
Golden, Colorado, United States, 80401
Pain Relief Center of Colorado
Arvada, Colorado, United States, 80002
Pain Care Specialists
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
Comprehensive Pain and Headache Treatment Centers, LLC
Derby, Connecticut, United States, 06418
United States, Florida
Clinical Pharmacology Services
Tampa, Florida, United States, 33617
West Gables Rehabilitation Hospital
Miami, Florida, United States, 33155
Florida Institute of Medical Research
Jacksonville, Florida, United States, 32207
Space Coast Pain Institute
Merritt Island, Florida, United States, 32953
Sarasota Pain Associates
Sarasota, Florida, United States, 34243
United States, Georgia
Shepherd Center, Inc.
Atlanta, Georgia, United States, 30309
Comprehensive Pain Care, PC
Marietta, Georgia, United States, 30060
United States, Illinois
The University of Chicago, Dept. of Surgery, Section of Neurosurgery
Chicago, Illinois, United States, 60637
United States, Indiana
Indianapolis Neurosurgical Group
Indianapolis, Indiana, United States, 46202
United States, Iowa
Des Moines Orthopedic Surgeons
West Des Moines, Iowa, United States, 50266
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
United States, Kentucky
Pain Control Network, PSC/PCN Surgical Suites, LLC
Louisville, Kentucky, United States, 40205
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Michigan
Wayne State University - School of Medicine
Detroit, Michigan, United States, 48201
United States, Minnesota
Medical Advanced Pain Specialists (MAPS)
Minneapolis, Minnesota, United States, 55433
United States, Mississippi
The Center for Pain Medicine
Hattiesburg, Mississippi, United States, 39402
United States, Missouri
Pain Management Associates, Clinical Research
Independence, Missouri, United States, 64055
St. John's Regional Healthcare
Springfield, Missouri, United States, 65804
United States, Nevada
Pain Management - Anesthesiology
Las Vegas, Nevada, United States, 89117
United States, New Hampshire
Dr. O'Connell's Pain Care Centers, Inc.
Somersworth, New Hampshire, United States, 03878
United States, New York
All Island Pain Consultants
Bay Shore, New York, United States, 11706
Medical Pain Management of Central New York
Syracuse, New York, United States, 13210
Cohn Pain Management Center
Bethpage, New York, United States, 11714
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
New York Presbyterian Hospital/Cornell Medical Center
New York, New York, United States, 10021
NYU Pain Management Center
New York, New York, United States, 10016
United States, North Carolina
Duke Medical Center Pain Clinic
Durham, North Carolina, United States, 27705
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cincinnati Centers for Pain Relief, Inc.
Hamilton, Ohio, United States, 45011
United States, Oklahoma
PETC Research Group, Inc.
Tulsa, Oklahoma, United States, 74137
United States, Oregon
Pain Management Consultants, PC
Portland, Oregon, United States, 97225
Pain Consultants of Oregon
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Magee Rehabilitation
Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina
Carolinas Center for Advanced Management of Pain
Spartanburg, South Carolina, United States, 29302
United States, South Dakota
Avera St. Luke's Hospital
Aberdeen, South Dakota, United States, 57401
United States, Texas
Consultants in Pain Research, PA
San Antonio, Texas, United States, 78217
International Pain Institute
Lubbock, Texas, United States, 79413
The University of Texas Medical Branch
Galveston, Texas, United States, 77555
Dallas Spine Care P.A.
Dallas, Texas, United States, 75235
Advanced Pain Medicine
Dallas, Texas, United States, 75237
American Pain & Wellness, PA
Plano, Texas, United States, 75093
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
University of Utah Pain Management Center
Salt Lake City, Utah, United States, 84108
United States, Virginia
Pain Management Center, University of Virginia
Charlottesville, Virginia, United States, 22903
United States, West Virginia
The Center for Pain Relief
Charleston, West Virginia, United States, 25301
Sponsors and Collaborators
Elan Pharmaceuticals
  More Information

No publications provided

Study ID Numbers: ELN92045-501
Study First Received: January 26, 2004
Last Updated: February 18, 2009
ClinicalTrials.gov Identifier: NCT00076544     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:
Intrathecal

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