Prialt (Ziconotide) In Severe Chronic Pain

Pain Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00047749
• Other study ID #: ELN92045-301
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2002
• Last updated: December 10, 2015
• Start date: August 2002
• Est. completion date: June 2003

Study information

• Verified date: December 2015
• Source: Elan Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

Drug:
• Prialt (ziconotide)

Locations

Country	Name	City	State
United States	Advanced Pain Medicine	Bakersfield	California
United States	Johns Hopkins Hospital, Division of Pain Management	Baltimore	Maryland
United States	Yellowstone Medical Center East	Billings	Montana
United States	Arnold Pain Management	Boston	Massachusetts
United States	Center for Pain Relief	Charleston	West Virginia
United States	MUSC, Neurological Surgery	Charleston	South Carolina
United States	Rush Presbyterian - St. Luke's Medical Center	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Pain Care Specialists	Colorado Springs	Colorado
United States	Cardinal Clinical Research Center	Cudahy	Wisconsin
United States	Advanced Pain Institute	Duarte	California
United States	Edina Medical Pain Center	Edina	Minnesota
United States	Pain Consultants of Oregon	Eugene	Oregon
United States	The RC Goodman Pain Institute: Clinical Research	Fort Smith	Arkansas
United States	Penn State University Hospital	Hershey	Pennsylvania
United States	Hot Springs Mercy Pain Clinic	Hot Springs	Arkansas
United States	University of Texas M.D. Anderson Cancer Center	Houston	Texas
United States	Huntington Center for Pain Treatment	Huntington	New York
United States	Tennesee Valley Pain Consultants - Center For Pain Management	Huntsville	Alabama
United States	Research Medical Center - Pain Institute	Kansas City	Missouri
United States	UCSD Medical Center, Thornton Hospital	La Jolla	California
United States	University of Kentucky, Dept Anesthesiology	Lexington	Kentucky
United States	Innovative Spine Care	Little Rock	Arkansas
United States	Abaci and Massey Pain Center	Los Gatos	California
United States	Texas Tech University HSC	Lubbock	Texas
United States	Georgia Medical Research Institute	Marietta	Georgia
United States	Methodist Comprehensive Pain Institute	Memphis	Tennessee
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Weill Medical College of Cornell University	New York	New York
United States	The Pain Center	Northport	Alabama
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Legacy Holladay Park Medical Center	Portland	Oregon
United States	Neurosurgery Foundation	Providence	Rhode Island
United States	Alpine Pain and Addiction Medicine	Salt Lake City	Utah
United States	Consultants in Pain Research	San Antonio	Texas
United States	UCSF Pain Management Center	San Francisco	California
United States	University of Washington Medical Center - Pain Center	Seattle	Washington
United States	Medical Pain Management of Central NY	Syracuse	New York
United States	Clinical Pharmacology Services, Inc.	Tampa	Florida
United States	Advanced Clinical Concepts	Temple	Pennsylvania
United States	Outcomes Research International	Tucson	Arizona
United States	Pain Institute of Tulsa	Tulsa	Oklahoma
United States	Advanced Pain Management and Rehabilitation	Virginia Beach	Virginia
United States	Center For Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Elan Pharmaceuticals

Country where clinical trial is conducted

United States, 

External Links

•   Ziconotide in severe chronic pain (search using ziconotide)