Prialt (Ziconotide) In Severe Chronic Pain

Completed · Phase 3

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT00047749

Run by

Elan Pharmaceuticals

People needed

220

Starts

2002-08-01

Expected to finish

2003-06-01

Last updated by the study team

2015-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tennesee Valley Pain Consultants - Center For Pain Management — Huntsville, Alabama, United States
• The Pain Center — Northport, Alabama, United States
• Outcomes Research International — Tucson, Arizona, United States
• The RC Goodman Pain Institute: Clinical Research — Fort Smith, Arkansas, United States
• Hot Springs Mercy Pain Clinic — Hot Springs, Arkansas, United States
• Innovative Spine Care — Little Rock, Arkansas, United States
• Advanced Pain Medicine — Bakersfield, California, United States
• Advanced Pain Institute — Duarte, California, United States
• UCSD Medical Center, Thornton Hospital — La Jolla, California, United States
• Abaci and Massey Pain Center — Los Gatos, California, United States
• UCSF Pain Management Center — San Francisco, California, United States
• Pain Care Specialists — Colorado Springs, Colorado, United States
• Clinical Pharmacology Services, Inc. — Tampa, Florida, United States
• Georgia Medical Research Institute — Marietta, Georgia, United States
• Rush Presbyterian - St. Luke's Medical Center — Chicago, Illinois, United States
• University of Kentucky, Dept Anesthesiology — Lexington, Kentucky, United States
• Johns Hopkins Hospital, Division of Pain Management — Baltimore, Maryland, United States
• Arnold Pain Management — Boston, Massachusetts, United States
• Edina Medical Pain Center — Edina, Minnesota, United States
• Research Medical Center - Pain Institute — Kansas City, Missouri, United States
• Yellowstone Medical Center East — Billings, Montana, United States
• Huntington Center for Pain Treatment — Huntington, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Medical Pain Management of Central NY — Syracuse, New York, United States
• Center For Clinical Research — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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