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| Sponsor: | Elan Pharmaceuticals |
|---|---|
| Information provided by: | Elan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00076544 |
Purpose
The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Ziconotide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study |
| Official Title: | An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Alabama Pain Center | |
| Huntsville, Alabama, United States, 35801 | |
| Center for Pain Management | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Outcomes Research International | |
| Tucson, Arizona, United States, 85712 | |
| Otto Uhrik, MD | |
| Sun City West, Arizona, United States, 85373 | |
| United States, Arkansas | |
| Innovative Spine Care | |
| Little Rock, Arkansas, United States, 72205 | |
| The RC Goodman Pain Institute | |
| Fort Smith, Arkansas, United States, 72901 | |
| United States, California | |
| Bay Area Pain Center | |
| Los Gatos, California, United States, 95032 | |
| Galileo Surgery Center | |
| San Luis Obispo, California, United States, 93405 | |
| Pacific Pain Treatment Centers | |
| San Francisco, California, United States, 94109 | |
| Shreenath Clinical Services | |
| Long Beach, California, United States, 90807 | |
| Shreenath Clinical Services | |
| Lake Forest, California, United States, 92630 | |
| Shreenath Clinical Services | |
| Beverly Hills, California, United States, 90211 | |
| Advanced Pain Institute | |
| Duarte, California, United States, 91010 | |
| Pacific Pain Medicine Consultants | |
| Oceanside, California, United States, 92056 | |
| Northridge Surgery & Pain Management Center | |
| Northridge, California, United States, 91324 | |
| United States, Colorado | |
| Rocky Mountain Clinical Research | |
| Golden, Colorado, United States, 80401 | |
| Pain Relief Center of Colorado | |
| Arvada, Colorado, United States, 80002 | |
| Pain Care Specialists | |
| Colorado Springs, Colorado, United States, 80907 | |
| United States, Connecticut | |
| Comprehensive Pain and Headache Treatment Centers, LLC | |
| Derby, Connecticut, United States, 06418 | |
| United States, Florida | |
| Clinical Pharmacology Services | |
| Tampa, Florida, United States, 33617 | |
| West Gables Rehabilitation Hospital | |
| Miami, Florida, United States, 33155 | |
| Florida Institute of Medical Research | |
| Jacksonville, Florida, United States, 32207 | |
| Space Coast Pain Institute | |
| Merritt Island, Florida, United States, 32953 | |
| Sarasota Pain Associates | |
| Sarasota, Florida, United States, 34243 | |
| United States, Georgia | |
| Shepherd Center, Inc. | |
| Atlanta, Georgia, United States, 30309 | |
| Comprehensive Pain Care, PC | |
| Marietta, Georgia, United States, 30060 | |
| United States, Illinois | |
| The University of Chicago, Dept. of Surgery, Section of Neurosurgery | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Indianapolis Neurosurgical Group | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Des Moines Orthopedic Surgeons | |
| West Des Moines, Iowa, United States, 50266 | |
| University of Iowa Health Care | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Pain Control Network, PSC/PCN Surgical Suites, LLC | |
| Louisville, Kentucky, United States, 40205 | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Michigan | |
| Wayne State University - School of Medicine | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Medical Advanced Pain Specialists (MAPS) | |
| Minneapolis, Minnesota, United States, 55433 | |
| United States, Mississippi | |
| The Center for Pain Medicine | |
| Hattiesburg, Mississippi, United States, 39402 | |
| United States, Missouri | |
| Pain Management Associates, Clinical Research | |
| Independence, Missouri, United States, 64055 | |
| St. John's Regional Healthcare | |
| Springfield, Missouri, United States, 65804 | |
| United States, Nevada | |
| Pain Management - Anesthesiology | |
| Las Vegas, Nevada, United States, 89117 | |
| United States, New Hampshire | |
| Dr. O'Connell's Pain Care Centers, Inc. | |
| Somersworth, New Hampshire, United States, 03878 | |
| United States, New York | |
| All Island Pain Consultants | |
| Bay Shore, New York, United States, 11706 | |
| Medical Pain Management of Central New York | |
| Syracuse, New York, United States, 13210 | |
| Cohn Pain Management Center | |
| Bethpage, New York, United States, 11714 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| New York Presbyterian Hospital/Cornell Medical Center | |
| New York, New York, United States, 10021 | |
| NYU Pain Management Center | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Duke Medical Center Pain Clinic | |
| Durham, North Carolina, United States, 27705 | |
| The Center for Clinical Research | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Cincinnati Centers for Pain Relief, Inc. | |
| Hamilton, Ohio, United States, 45011 | |
| United States, Oklahoma | |
| PETC Research Group, Inc. | |
| Tulsa, Oklahoma, United States, 74137 | |
| United States, Oregon | |
| Pain Management Consultants, PC | |
| Portland, Oregon, United States, 97225 | |
| Pain Consultants of Oregon | |
| Eugene, Oregon, United States, 97401 | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital | |
| Allentown, Pennsylvania, United States, 18103 | |
| Magee Rehabilitation | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| United States, South Carolina | |
| Carolinas Center for Advanced Management of Pain | |
| Spartanburg, South Carolina, United States, 29302 | |
| United States, South Dakota | |
| Avera St. Luke's Hospital | |
| Aberdeen, South Dakota, United States, 57401 | |
| United States, Texas | |
| Consultants in Pain Research, PA | |
| San Antonio, Texas, United States, 78217 | |
| International Pain Institute | |
| Lubbock, Texas, United States, 79413 | |
| The University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555 | |
| Dallas Spine Care P.A. | |
| Dallas, Texas, United States, 75235 | |
| Advanced Pain Medicine | |
| Dallas, Texas, United States, 75237 | |
| American Pain & Wellness, PA | |
| Plano, Texas, United States, 75093 | |
| United States, Utah | |
| Lifetree Clinical Research | |
| Salt Lake City, Utah, United States, 84106 | |
| University of Utah Pain Management Center | |
| Salt Lake City, Utah, United States, 84108 | |
| United States, Virginia | |
| Pain Management Center, University of Virginia | |
| Charlottesville, Virginia, United States, 22903 | |
| United States, West Virginia | |
| The Center for Pain Relief | |
| Charleston, West Virginia, United States, 25301 | |
More Information
| Study ID Numbers: | ELN92045-501 |
| Study First Received: | January 26, 2004 |
| Last Updated: | February 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00076544 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Intrathecal |
|
Ziconotide Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Calcium Channel Blockers Cardiovascular Agents Neuroprotective Agents Protective Agents Pharmacologic Actions |
Membrane Transport Modulators Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Peripheral Nervous System Agents Analgesics Central Nervous System Agents |