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Home > "P" Clinical Trials Conditions > Prialt (ziconotide) In Severe Chronic Pain  Prialt (ziconotide) In Severe Chronic Pain
Prialt (ziconotide) In Severe Chronic Pain
For Condition: Pain
Status: Completed
Sponsor(s): Elan Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 220
Location and Contact Information:
Neurosurgery Foundation
Providence, Rhode Island, 02903
United States
Center for Pain Relief
Charleston, West Virginia, 25301
United States
Pain Institute of Tulsa
Tulsa, Oklahoma, 74137
United States
Tennesee Valley Pain Consultants - Center For Pain Management
Huntsville, Alabama, 35801
United States
Abaci and Massey Pain Center
Los Gatos, California, 95032
United States
Yellowstone Medical Center East
Billings, Montana, 59101
United States
Innovative Spine Care
Little Rock, Arkansas, 72205
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Arnold Pain Management
Boston, Massachusetts, 02215
United States
The RC Goodman Pain Institute: Clinical Research
Fort Smith, Arkansas, 72901
United States
Hot Springs Mercy Pain Clinic
Hot Springs, Arkansas, 71913
United States
Penn State University Hospital
Hershey, Pennsylvania, 17033
United States
Georgia Medical Research Institute
Marietta, Georgia, 30060
United States
Methodist Comprehensive Pain Institute
Memphis, Tennessee, 38104
United States
Rush Presbyterian - St. Luke's Medical Center
Chicago, Illinois, 60612
United States
University of Kentucky, Dept Anesthesiology
Lexington, Kentucky, 40536
United States
Weill Medical College of Cornell University
New York City, New York, 10021
United States
Pain Consultants of Oregon
Eugene, Oregon, 97401
United States
Advanced Pain Institute
Duarte, California, 91010
United States
UCSD Medical Center, Thornton Hospital
La Jolla, California, 92037
United States
Medical Pain Management of Central NY
Syracuse, New York, 13210
United States
Clinical Pharmacology Services, Inc.
Tampa, Florida, 33617
United States
Huntington Center for Pain Treatment
Huntington, New York, 11743
United States
Advanced Pain Medicine
Bakersfield, California, 93311
United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
United States
UCSF Pain Management Center
San Francisco, California, 94143-1654
United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
United States
Outcomes Research International
Tucson, Arizona, 85711
United States
Legacy Holladay Park Medical Center
Portland, Oregon, 97232
United States
University of Washington Medical Center - Pain Center
Seattle, Washington, 98195
United States
Pain Care Specialists
Colorado Springs, Colorado, 80907
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
MUSC, Neurological Surgery
Charleston, South Carolina, 29425
United States
Johns Hopkins Hospital, Division of Pain Management
Baltimore, Maryland, 21205
United States
Research Medical Center - Pain Institute
Kansas City, Missouri, 64132
United States
Advanced Pain Management and Rehabilitation
Virginia Beach, Virginia, 23454
United States
Alpine Pain and Addiction Medicine
Salt Lake City, Utah, 84107
United States
Consultants in Pain Research
San Antonio, Texas, 78217
United States
The Pain Center
Northport, Alabama, 35476
United States
Cardinal Clinical Research Center
Cudahy, Wisconsin, 53110
United States
Edina Medical Pain Center
Edina, Minnesota, 55435
United States
Texas Tech University HSC
Lubbock, Texas, 79430
United States
Advanced Clinical Concepts
Temple, Pennsylvania, 19560
United States
Center For Clinical Research
Winston Salem, North Carolina, 27103
United States
Additional Information:
Study ID Numbers: ELN92045-301;
Study Start Date: August 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047749
Other Pain Studies:
1. Nonpharmacologic Analgesia for Invasive Procedures
2. NGX-4010 for the Treatment of Postherpetic Neuralgia
3. Studies of Dextromethorphan and Topiramate to Treat Oral and Facial Pain
4. Acupuncture and Acupressure in Treating Patients With Moderate or Severe Pain Related to Stage III or Stage IV Pancreatic Cancer
5. Rofecoxib and Bupivacaine to Prevent Pain after Third Molar (Wisdom Tooth) Extraction
Related Studies:
Other Pain Clinical Trials
Other Texas Clinical Trials
Other Lubbock Clinical Trials
Prialt (ziconotide) In Severe Chronic Pain
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