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


Phase 3
18 Years
N/A
Not Enrolling
Both
Pain

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
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.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

ELN92045-301

NCT ID:

NCT00047749

Start Date:

August 2002

Completion Date:

June 2003

Related Keywords:

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

Name

Location

Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
Weill Medical College of Cornell UniversityNew York, New York  10021
University of Texas M.D. Anderson Cancer CenterHouston, Texas  77030
The Cleveland Clinic FoundationCleveland, Ohio  
Tennesee Valley Pain Consultants - Center For Pain ManagementHuntsville, Alabama  35801
The Pain CenterNorthport, Alabama  35476
Outcomes Research InternationalTucson, Arizona  85711
The RC Goodman Pain Institute: Clinical ResearchFort Smith, Arkansas  72901
Hot Springs Mercy Pain ClinicHot Springs, Arkansas  71913
Innovative Spine CareLittle Rock, Arkansas  72205
Advanced Pain MedicineBakersfield, California  93311
Advanced Pain InstituteDuarte, California  91010
UCSD Medical Center, Thornton HospitalLa Jolla, California  92037
Abaci and Massey Pain CenterLos Gatos, California  95032
UCSF Pain Management CenterSan Francisco, California  94143-1654
Pain Care SpecialistsColorado Springs, Colorado  80907
Clinical Pharmacology Services, Inc.Tampa, Florida  33617
Georgia Medical Research InstituteMarietta, Georgia  30060
Rush Presbyterian - St. Luke's Medical CenterChicago, Illinois  60612
University of Kentucky, Dept AnesthesiologyLexington, Kentucky  40536
Johns Hopkins Hospital, Division of Pain ManagementBaltimore, Maryland  21205
Arnold Pain ManagementBoston, Massachusetts  02215
Edina Medical Pain CenterEdina, Minnesota  55435
Research Medical Center - Pain InstituteKansas City, Missouri  64132
Yellowstone Medical Center EastBillings, Montana  59101
Huntington Center for Pain TreatmentHuntington, New York  11743
Medical Pain Management of Central NYSyracuse, New York  13210
Center For Clinical ResearchWinston Salem, North Carolina  27103
Pain Institute of TulsaTulsa, Oklahoma  74137
Pain Consultants of OregonEugene, Oregon  97401
Legacy Holladay Park Medical CenterPortland, Oregon  97232
Penn State University HospitalHershey, Pennsylvania  17033
Advanced Clinical ConceptsTemple, Pennsylvania  19560
Neurosurgery FoundationProvidence, Rhode Island  02903
MUSC, Neurological SurgeryCharleston, South Carolina  29425
Methodist Comprehensive Pain InstituteMemphis, Tennessee  38104
Clinical Research Associates, Inc.Nashville, Tennessee  37203
Texas Tech University HSCLubbock, Texas  79430
Consultants in Pain ResearchSan Antonio, Texas  78217
Alpine Pain and Addiction MedicineSalt Lake City, Utah  84107
Advanced Pain Management and RehabilitationVirginia Beach, Virginia  23454
University of Washington Medical Center - Pain CenterSeattle, Washington  98195
Center for Pain ReliefCharleston, West Virginia  25301
Cardinal Clinical Research CenterCudahy, Wisconsin  53110