Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain

Pain Clinical Trial

Official title:

An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00076544
• Other study ID #: ELN92045-501
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2004
• Last updated: December 10, 2015
• Start date: February 2004

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ziconotide

Locations

Country	Name	City	State
United States	Avera St. Luke's Hospital	Aberdeen	South Dakota
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Pain Relief Center of Colorado	Arvada	Colorado
United States	Shepherd Center, Inc.	Atlanta	Georgia
United States	All Island Pain Consultants	Bay Shore	New York
United States	Cohn Pain Management Center	Bethpage	New York
United States	Shreenath Clinical Services	Beverly Hills	California
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	The Center for Pain Relief	Charleston	West Virginia
United States	Pain Management Center, University of Virginia	Charlottesville	Virginia
United States	The University of Chicago, Dept. of Surgery, Section of Neurosurgery	Chicago	Illinois
United States	Pain Care Specialists	Colorado Springs	Colorado
United States	Advanced Pain Medicine	Dallas	Texas
United States	Dallas Spine Care P.A.	Dallas	Texas
United States	Comprehensive Pain and Headache Treatment Centers, LLC	Derby	Connecticut
United States	Wayne State University - School of Medicine	Detroit	Michigan
United States	Advanced Pain Institute	Duarte	California
United States	Duke Medical Center Pain Clinic	Durham	North Carolina
United States	Pain Consultants of Oregon	Eugene	Oregon
United States	The RC Goodman Pain Institute	Fort Smith	Arkansas
United States	The University of Texas Medical Branch	Galveston	Texas
United States	Rocky Mountain Clinical Research	Golden	Colorado
United States	Cincinnati Centers for Pain Relief, Inc.	Hamilton	Ohio
United States	The Center for Pain Medicine	Hattiesburg	Mississippi
United States	Alabama Pain Center	Huntsville	Alabama
United States	Center for Pain Management	Huntsville	Alabama
United States	Pain Management Associates, Clinical Research	Independence	Missouri
United States	Indianapolis Neurosurgical Group	Indianapolis	Indiana
United States	University of Iowa Health Care	Iowa City	Iowa
United States	Florida Institute of Medical Research	Jacksonville	Florida
United States	Shreenath Clinical Services	Lake Forest	California
United States	Pain Management - Anesthesiology	Las Vegas	Nevada
United States	University of Kentucky	Lexington	Kentucky
United States	Innovative Spine Care	Little Rock	Arkansas
United States	Shreenath Clinical Services	Long Beach	California
United States	Bay Area Pain Center	Los Gatos	California
United States	Pain Control Network, PSC/PCN Surgical Suites, LLC	Louisville	Kentucky
United States	International Pain Institute	Lubbock	Texas
United States	Comprehensive Pain Care, PC	Marietta	Georgia
United States	Space Coast Pain Institute	Merritt Island	Florida
United States	West Gables Rehabilitation Hospital	Miami	Florida
United States	Medical Advanced Pain Specialists (MAPS)	Minneapolis	Minnesota
United States	New York Presbyterian Hospital/Cornell Medical Center	New York	New York
United States	NYU Pain Management Center	New York	New York
United States	Northridge Surgery & Pain Management Center	Northridge	California
United States	Pacific Pain Medicine Consultants	Oceanside	California
United States	Magee Rehabilitation	Philadelphia	Pennsylvania
United States	American Pain & Wellness, PA	Plano	Texas
United States	Pain Management Consultants, PC	Portland	Oregon
United States	Lifetree Clinical Research	Salt Lake City	Utah
United States	University of Utah Pain Management Center	Salt Lake City	Utah
United States	Consultants in Pain Research, PA	San Antonio	Texas
United States	Pacific Pain Treatment Centers	San Francisco	California
United States	Galileo Surgery Center	San Luis Obispo	California
United States	Sarasota Pain Associates	Sarasota	Florida
United States	Dr. O'Connell's Pain Care Centers, Inc.	Somersworth	New Hampshire
United States	Carolinas Center for Advanced Management of Pain	Spartanburg	South Carolina
United States	St. John's Regional Healthcare	Springfield	Missouri
United States	Otto Uhrik, MD	Sun City West	Arizona
United States	Medical Pain Management of Central New York	Syracuse	New York
United States	Clinical Pharmacology Services	Tampa	Florida
United States	Outcomes Research International	Tucson	Arizona
United States	PETC Research Group, Inc.	Tulsa	Oklahoma
United States	Des Moines Orthopedic Surgeons	West Des Moines	Iowa
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Elan Pharmaceuticals

Country where clinical trial is conducted

United States,