Clinical trial NCT00076544: Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain
Official title: An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Intrathecal
Lead sponsor: Elan Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-02-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.


Eligibility criteria: 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.

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