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

Phase 3
18 Years
Not Enrolling

Thank you

Trial Information

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

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

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.

Type of Study:


Study Design:

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


United States: Food and Drug Administration

Study ID:




Start Date:

August 2002

Completion Date:

June 2003

Related Keywords:

  • Pain
  • pain
  • ziconotide
  • Prialt
  • intrathecal
  • Synchromed



Allegheny General Hospital Pittsburgh, Pennsylvania  15212-4772
Weill Medical College of Cornell University New York, New York  10021
University of Texas M.D. Anderson Cancer Center Houston, Texas  77030
The Cleveland Clinic Foundation Cleveland, Ohio  
Tennesee Valley Pain Consultants - Center For Pain Management Huntsville, Alabama  35801
The Pain Center Northport, Alabama  35476
Outcomes Research International Tucson, Arizona  85711
The RC Goodman Pain Institute: Clinical Research Fort Smith, Arkansas  72901
Hot Springs Mercy Pain Clinic Hot Springs, Arkansas  71913
Innovative Spine Care Little Rock, Arkansas  72205
Advanced Pain Medicine Bakersfield, California  93311
Advanced Pain Institute Duarte, California  91010
UCSD Medical Center, Thornton Hospital La Jolla, California  92037
Abaci and Massey Pain Center Los Gatos, California  95032
UCSF Pain Management Center San Francisco, California  94143-1654
Pain Care Specialists Colorado Springs, Colorado  80907
Clinical Pharmacology Services, Inc. Tampa, Florida  33617
Georgia Medical Research Institute Marietta, Georgia  30060
Rush Presbyterian - St. Luke's Medical Center Chicago, Illinois  60612
University of Kentucky, Dept Anesthesiology Lexington, Kentucky  40536
Johns Hopkins Hospital, Division of Pain Management Baltimore, Maryland  21205
Arnold Pain Management Boston, Massachusetts  02215
Edina Medical Pain Center Edina, Minnesota  55435
Research Medical Center - Pain Institute Kansas City, Missouri  64132
Yellowstone Medical Center East Billings, Montana  59101
Huntington Center for Pain Treatment Huntington, New York  11743
Medical Pain Management of Central NY Syracuse, New York  13210
Center For Clinical Research Winston Salem, North Carolina  27103
Pain Institute of Tulsa Tulsa, Oklahoma  74137
Pain Consultants of Oregon Eugene, Oregon  97401
Legacy Holladay Park Medical Center Portland, Oregon  97232
Penn State University Hospital Hershey, Pennsylvania  17033
Advanced Clinical Concepts Temple, Pennsylvania  19560
Neurosurgery Foundation Providence, Rhode Island  02903
MUSC, Neurological Surgery Charleston, South Carolina  29425
Methodist Comprehensive Pain Institute Memphis, Tennessee  38104
Clinical Research Associates, Inc. Nashville, Tennessee  37203
Texas Tech University HSC Lubbock, Texas  79430
Consultants in Pain Research San Antonio, Texas  78217
Alpine Pain and Addiction Medicine Salt Lake City, Utah  84107
Advanced Pain Management and Rehabilitation Virginia Beach, Virginia  23454
University of Washington Medical Center - Pain Center Seattle, Washington  98195
Center for Pain Relief Charleston, West Virginia  25301
Cardinal Clinical Research Center Cudahy, Wisconsin  53110