Prialt (ziconotide) In Severe Chronic Pain - Trial

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Prialt (ziconotide) In Severe Chronic Pain

This study is currently recruiting patients.

Sponsored by

Elan Pharmaceuticals

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

Treatment or Intervention

Phase

Pain

Drug: Prialt (ziconotide)

Phase III

MEDLINEplus related topics: Pain

Study Type: InterventionalStudy Design: Treatment, Randomized, Double-Blind Method, 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

Eligibility

Ages Eligible for Study: 18 Years and above , Genders Eligible for Study: Both

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.

Expected Total Enrollment: 220

Location and Contact Information

Alabama

Tennesee Valley Pain Consultants - Center For Pain Management, Huntsville, Alabama, 35801, United States; Recruiting

Carol Westin , MD, Principal Investigator

The Pain Center, Northport, Alabama, 35476, United States; Recruiting

Rhonda Turnipseed Eugene A Mangieri, MD, Principal Investigator

Arizona

Outcomes Research International, Tucson, Arizona, 85711, United States; Recruiting

Arslanian Larry Putnam, MD, Principal Investigator

Arkansas

Hot Springs Mercy Pain Clinic, Hot Springs, Arkansas, 71913, United States; Recruiting

Marquita Busch E Abraham, MD, Principal Investigator

Innovative Spine Care, Little Rock, Arkansas, 72205, United States; Recruiting

Whitney Duncan Carl M Covey, MD, Principal Investigator

The RC Goodman Pain Institute: Clinical Research, Fort , Arkansas, 72901, United States; Recruiting

Kim Pulliam Fisher, MD, Principal Investigator

California

Advanced Pain Medicine, Bakersfield, California, 93311, United States; Recruiting

Sharon Crume Ext. 208 Theresa Ferrer-Brechner, MD, Principal Investigator

Abaci and Massey Pain Center, Los Gatos, California, 95032, United States; Recruiting

Sally Adelus Micheal Leong, MD, Principal Investigator

Advanced Pain Institute, Duarte, California, 91010, United States; Recruiting

a Minehart, MD, Principal Investigator

UCSF Pain Management Center, San Francisco, California, 94143-1654, United States; Not yet recruiting

Aimee Chagnon Pamela Palmer, MD, Principal Investigator

UCSD Medical Center, Thornton Hospital, La Jolla, California, 92037, United States; Recruiting

Suzanne Daneshvari Mark Wallace, MD, Principal Investigator

Colorado

Pain Care Specialists, Colorado Springs, Colorado, 80907, United States; Recruiting

Shar Larson Presley, MD, Principal Investigator

Florida

Clinical Pharmacology Services, Inc., Tampa, Florida, 33617, United States; Recruiting

Carol Donna Buffington, Pharm D, Principal Investigator

Illinois

Pain Specialists of Greater Chicago, Burr Ridge, Illinois, 60527, United States; Recruiting

Jan son Neeraj Jain, MD, Principal Investigator

Rush Presbyterian - St. Luke's Medical Center, Chicago, Illinois, 60612, United States; Recruiting

Dalia Elmofty R Lubenow, MD, Principal Investigator

land

s Hopkins Hospital, Division of Pain Management, Baltimore, land, 21205, United States; Not yet recruiting

Fred Luthardt Staats, MD, Principal Investigator

Massachusetts

Arnold Pain Management, Boston, Massachusetts, 02215, United States; Recruiting

Dyanna DeMarco Zahid Bajwa, MD, Principal Investigator

Minnesota

Edina Medical Pain Center, Edina, Minnesota, 55435, United States; Recruiting

Peg Beltrand Schultz, MD, Principal Investigator

Missouri

Research Medical Center - Pain Institute, Kansas City, Missouri, 64132, United States; Recruiting

McClafferty Charapata, MD, Principal Investigator

Montana

Yellowstone Medical Center East, Billings, Montana, 59101, United States; Recruiting

Joan C Oakley, MD, Principal Investigator

New York

Huntington Center for Pain Treatment, Huntington, New York, 11743, United States; Recruiting

Wallace Nolan Tzou, MD, Principal Investigator

North Carolina

Center For Clinical Research, Winston Salem, North Carolina, 27103, United States; Recruiting

Torey Browning L Rauck, MD, Principal Investigator

Ohio

The Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States; Not yet recruiting

Beven Stanton-Hicks, MD, Principal Investigator

Oklahoma

Pain Institute of Tulsa, Tulsa, Oklahoma, 74137, United States; Recruiting

Joy Valentino F Sorenson, MD, Principal Investigator

Oregon

Pain Consultants of Oregon, Eugene, Oregon, 97401, United States; Recruiting

Jane Torey Kosek, MD, Principal Investigator

Legacy Holladay Park Medical Center, Portland, Oregon, 97232, United States; Recruiting

Latania Chura Stuart Rosenblum, MD, Principal Investigator

Pennsylvania

Allegheny Pain Management, PC, Altoona, Pennsylvania, 16601, United States; Recruiting

Drass, MD, Principal Investigator

Jefferson Pain Center, Philadelphia, Pennsylvania, 19107, United States; Recruiting

Lynette Menefee Evan , MD, Principal Investigator

Penn State University Hospital, Hershey, Pennsylvania, 17033, United States; Not yet recruiting

Gregg Schuler Vitaly Gordin, MD, Principal Investigator

Advanced Clinical Concepts, Temple, Pennsylvania, 19560, United States; Recruiting

Jan Petrie Pam Sherer Mortazavi, MD, Principal Investigator

Allegheny General Hospital, Pittsburgh, Pennsylvania, 15212, United States; Recruiting

Diane Cantell Jack E Wilberger, MD, Principal Investigator

South Carolina

MUSC, Neurological Surgery, ton, South Carolina, 29425, United States; Recruiting

Bonnie Muntz-Pope Istvan Takacs, MD, Principal Investigator

Tennessee

Methodist Comprehensive Pain Institute, Memphis, Tennessee, 38104, United States; Recruiting

Charlotte Burns Brookhoff, MD, Principal Investigator

Texas

University of Texas M.D. Cancer Center, Houston, Texas, 77030, United States; Not yet recruiting

Margaret Harle W Burton, MD, Principal Investigator

Texas Tech University HSC, Lubbock, Texas, 79430, United States; Not yet recruiting

Dani Joyner Gabor B Racz, MD, Principal Investigator

Utah

Wasatch Clinical Research - Pain and Stress Clinic, Salt Lake City, Utah, 84107, United States; Recruiting

Lynn Webster, MD, Principal Investigator

Washington

University of Washington Medical Center - Pain Center, Seattle, Washington, 98195, United States; Recruiting

Strom Loeser, MD, Principal Investigator

West Virginia

Center for Pain Relief, ton, West Virginia, 25301, United States; Recruiting

Summer Pack R Deer, MD, Principal Investigator

Wisconsin

Cardinal Clinical Research Center, Cudahy, Wisconsin, 53110, United States; Recruiting

Glanz Yogendra Bharat, MD, Principal Investigator

More Information

Ziconotide in severe chronic pain (search using ziconotide)

Study ID Numbers ELN92045-301

Date study started August 2002; Study Completion Date June 2003 Record last reviewed November 2002

NLM Identifier NCT00047749 ClinicalTrials.gov processed this record on 2002-11-