|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Elan Pharmaceuticals |
|---|---|
| Information provided by: | Elan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00047749 |
Purpose
The purpose of this study is to understand the effects of intrathecal ziconotide (an experimental pain medication) when the dose is slowly increased over a 3-week period in patients with severe chronic pain. During the weaning phase, the study will also gather information about switching from other intrathecal or IT medication (slowly pumped directly into the space around the spine) to other systemic pain medication (by mouth or through the skin using a patch). After being weaned off current IT medication, patients will be placed on IT ziconotide or placebo (non-active substance) as well as being allowed a stable dose of systemic pain medications.
Patients who complete this study may be eligible for long-term ziconotide therapy via extension protocol ELN92045-352.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Prialt (ziconotide) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Males and their partner(s) of childbearing age must use adequate, appropriate contraceptive methods.
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Tennesee Valley Pain Consultants - Center For Pain Management | |
| Huntsville, Alabama, United States, 35801 | |
| The Pain Center | |
| Northport, Alabama, United States, 35476 | |
| United States, Arizona | |
| Outcomes Research International | |
| Tucson, Arizona, United States, 85711 | |
| United States, Arkansas | |
| Hot Springs Mercy Pain Clinic | |
| Hot Springs, Arkansas, United States, 71913 | |
| Innovative Spine Care | |
| Little Rock, Arkansas, United States, 72205 | |
| The RC Goodman Pain Institute: Clinical Research | |
| Fort Smith, Arkansas, United States, 72901 | |
| United States, California | |
| Advanced Pain Medicine | |
| Bakersfield, California, United States, 93311 | |
| Abaci and Massey Pain Center | |
| Los Gatos, California, United States, 95032 | |
| Advanced Pain Institute | |
| Duarte, California, United States, 91010 | |
| UCSF Pain Management Center | |
| San Francisco, California, United States, 94143-1654 | |
| UCSD Medical Center, Thornton Hospital | |
| La Jolla, California, United States, 92037 | |
| United States, Colorado | |
| Pain Care Specialists | |
| Colorado Springs, Colorado, United States, 80907 | |
| United States, Florida | |
| Clinical Pharmacology Services, Inc. | |
| Tampa, Florida, United States, 33617 | |
| United States, Georgia | |
| Georgia Medical Research Institute | |
| Marietta, Georgia, United States, 30060 | |
| United States, Illinois | |
| Rush Presbyterian - St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kentucky | |
| University of Kentucky, Dept Anesthesiology | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Maryland | |
| Johns Hopkins Hospital, Division of Pain Management | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Arnold Pain Management | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Edina Medical Pain Center | |
| Edina, Minnesota, United States, 55435 | |
| United States, Missouri | |
| Research Medical Center - Pain Institute | |
| Kansas City, Missouri, United States, 64132 | |
| United States, Montana | |
| Yellowstone Medical Center East | |
| Billings, Montana, United States, 59101 | |
| United States, New York | |
| Huntington Center for Pain Treatment | |
| Huntington, New York, United States, 11743 | |
| Medical Pain Management of Central NY | |
| Syracuse, New York, United States, 13210 | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Center For Clinical Research | |
| Winston Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| Pain Institute of Tulsa | |
| Tulsa, Oklahoma, United States, 74137 | |
| United States, Oregon | |
| Pain Consultants of Oregon | |
| Eugene, Oregon, United States, 97401 | |
| Legacy Holladay Park Medical Center | |
| Portland, Oregon, United States, 97232 | |
| United States, Pennsylvania | |
| Penn State University Hospital | |
| Hershey, Pennsylvania, United States, 17033 | |
| Advanced Clinical Concepts | |
| Temple, Pennsylvania, United States, 19560 | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, Rhode Island | |
| Neurosurgery Foundation | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| MUSC, Neurological Surgery | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Methodist Comprehensive Pain Institute | |
| Memphis, Tennessee, United States, 38104 | |
| Clinical Research Associates, Inc. | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Texas Tech University HSC | |
| Lubbock, Texas, United States, 79430 | |
| Consultants in Pain Research | |
| San Antonio, Texas, United States, 78217 | |
| United States, Utah | |
| Alpine Pain and Addiction Medicine | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Virginia | |
| Advanced Pain Management and Rehabilitation | |
| Virginia Beach, Virginia, United States, 23454 | |
| United States, Washington | |
| University of Washington Medical Center - Pain Center | |
| Seattle, Washington, United States, 98195 | |
| United States, West Virginia | |
| Center for Pain Relief | |
| Charleston, West Virginia, United States, 25301 | |
| United States, Wisconsin | |
| Cardinal Clinical Research Center | |
| Cudahy, Wisconsin, United States, 53110 | |
More Information
| Study ID Numbers: | ELN92045-301 |
| Study First Received: | October 16, 2002 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00047749 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
pain ziconotide Prialt intrathecal Synchromed |
|
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 |