Clinical trial NCT00047749: Prialt (Ziconotide) In Severe Chronic Pain
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: pain
ziconotide
Prialt
intrathecal
Synchromed
Lead sponsor: Elan Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2002-10-17
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

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