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Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain

Sponsor
Elan Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00076544
Collaborator
(none)
300
Enrollment
65
Locations
4.6
Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain
Study Start Date :
Feb 1, 2004
Actual Primary Completion Date :
Mar 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama Pain Center Huntsville Alabama United States 35801
    2 Center for Pain Management Huntsville Alabama United States 35801
    3 Otto Uhrik, MD Sun City West Arizona United States 85373
    4 Outcomes Research International Tucson Arizona United States 85712
    5 The RC Goodman Pain Institute Fort Smith Arkansas United States 72901
    6 Innovative Spine Care Little Rock Arkansas United States 72205
    7 Shreenath Clinical Services Beverly Hills California United States 90211
    8 Advanced Pain Institute Duarte California United States 91010
    9 Shreenath Clinical Services Lake Forest California United States 92630
    10 Shreenath Clinical Services Long Beach California United States 90807
    11 Bay Area Pain Center Los Gatos California United States 95032
    12 Northridge Surgery & Pain Management Center Northridge California United States 91324
    13 Pacific Pain Medicine Consultants Oceanside California United States 92056
    14 Pacific Pain Treatment Centers San Francisco California United States 94109
    15 Galileo Surgery Center San Luis Obispo California United States 93405
    16 Pain Relief Center of Colorado Arvada Colorado United States 80002
    17 Pain Care Specialists Colorado Springs Colorado United States 80907
    18 Rocky Mountain Clinical Research Golden Colorado United States 80401
    19 Comprehensive Pain and Headache Treatment Centers, LLC Derby Connecticut United States 06418
    20 Florida Institute of Medical Research Jacksonville Florida United States 32207
    21 Space Coast Pain Institute Merritt Island Florida United States 32953
    22 West Gables Rehabilitation Hospital Miami Florida United States 33155
    23 Sarasota Pain Associates Sarasota Florida United States 34243
    24 Clinical Pharmacology Services Tampa Florida United States 33617
    25 Shepherd Center, Inc. Atlanta Georgia United States 30309
    26 Comprehensive Pain Care, PC Marietta Georgia United States 30060
    27 The University of Chicago, Dept. of Surgery, Section of Neurosurgery Chicago Illinois United States 60637
    28 Indianapolis Neurosurgical Group Indianapolis Indiana United States 46202
    29 University of Iowa Health Care Iowa City Iowa United States 52242
    30 Des Moines Orthopedic Surgeons West Des Moines Iowa United States 50266
    31 University of Kentucky Lexington Kentucky United States 40536
    32 Pain Control Network, PSC/PCN Surgical Suites, LLC Louisville Kentucky United States 40205
    33 Wayne State University - School of Medicine Detroit Michigan United States 48201
    34 Medical Advanced Pain Specialists (MAPS) Minneapolis Minnesota United States 55433
    35 The Center for Pain Medicine Hattiesburg Mississippi United States 39402
    36 Pain Management Associates, Clinical Research Independence Missouri United States 64055
    37 St. John's Regional Healthcare Springfield Missouri United States 65804
    38 Pain Management - Anesthesiology Las Vegas Nevada United States 89117
    39 Dr. O'Connell's Pain Care Centers, Inc. Somersworth New Hampshire United States 03878
    40 All Island Pain Consultants Bay Shore New York United States 11706
    41 Cohn Pain Management Center Bethpage New York United States 11714
    42 Roswell Park Cancer Institute Buffalo New York United States 14263
    43 NYU Pain Management Center New York New York United States 10016
    44 New York Presbyterian Hospital/Cornell Medical Center New York New York United States 10021
    45 Medical Pain Management of Central New York Syracuse New York United States 13210
    46 Duke Medical Center Pain Clinic Durham North Carolina United States 27705
    47 The Center for Clinical Research Winston-Salem North Carolina United States 27103
    48 Cincinnati Centers for Pain Relief, Inc. Hamilton Ohio United States 45011
    49 PETC Research Group, Inc. Tulsa Oklahoma United States 74137
    50 Pain Consultants of Oregon Eugene Oregon United States 97401
    51 Pain Management Consultants, PC Portland Oregon United States 97225
    52 Lehigh Valley Hospital Allentown Pennsylvania United States 18103
    53 Magee Rehabilitation Philadelphia Pennsylvania United States 19102
    54 Carolinas Center for Advanced Management of Pain Spartanburg South Carolina United States 29302
    55 Avera St. Luke's Hospital Aberdeen South Dakota United States 57401
    56 Dallas Spine Care P.A. Dallas Texas United States 75235
    57 Advanced Pain Medicine Dallas Texas United States 75237
    58 The University of Texas Medical Branch Galveston Texas United States 77555
    59 International Pain Institute Lubbock Texas United States 79413
    60 American Pain & Wellness, PA Plano Texas United States 75093
    61 Consultants in Pain Research, PA San Antonio Texas United States 78217
    62 Lifetree Clinical Research Salt Lake City Utah United States 84106
    63 University of Utah Pain Management Center Salt Lake City Utah United States 84108
    64 Pain Management Center, University of Virginia Charlottesville Virginia United States 22903
    65 The Center for Pain Relief Charleston West Virginia United States 25301

    Sponsors and Collaborators

    • Elan Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00076544
    Other Study ID Numbers:
    • ELN92045-501
    First Posted:
    Feb 4, 2004
    Last Update Posted:
    Dec 14, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by , ,
    Intrathecal
    Additional relevant MeSH terms:
    Ziconotide

    Study Results

    No Results Posted as of Dec 14, 2015