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Sponsors and Collaborators: |
Diamond Headache Clinic Merck |
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Information provided by: | Diamond Headache Clinic |
ClinicalTrials.gov Identifier: | NCT00300924 |
The purpose of this study is to test an experimental drug combination of two medications currently approved by the Food and Drug Administration (FDA) for migraine headache or other pain. These are called rizatriptan given with acetaminophen.
Condition | Intervention | Phase |
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Migraine |
Drug: Rizatriptan co-administered with Acetaminophen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Double-Dummy, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10mg Co-Administered With Acetaminophen for the Treatment of Acute Migraine. |
Estimated Enrollment: | 200 |
Study Start Date: | March 2006 |
Study Completion Date: | January 2007 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
*This list is not all inclusive*
United States, California | |
SanFrancisco Headache Clinic | |
San Francisco, California, United States, 94109 | |
United States, Illinois | |
Diamond Headache Clinic | |
Chicago, Illinois, United States, 60614 | |
United States, Michigan | |
Westside Family Medical Center | |
Kalamazoo, Michigan, United States, 49009 | |
United States, Missouri | |
Clinvest | |
Springfield, Missouri, United States | |
Mercy Health Research | |
St. Louis, Missouri, United States, 63141 | |
United States, New York | |
Elkind Headache Center | |
Mount Vernon, New York, United States, 10550 | |
United States, Ohio | |
ClinExcel | |
West Chester, Ohio, United States, 44121 |
Study Director: | Merle Diamond, M.D. | Diamond Headache Clinic |
Responsible Party: | Diamond Headache Clinic ( Karin E. Brooks, BSN, RN Director of Clinical Research ) |
Study ID Numbers: | Merck 075-00, Merk 075-00 |
Study First Received: | March 9, 2006 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00300924 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Serotonin Agonists Neurotransmitter Agents Central Nervous System Diseases Headache Disorders, Primary Rizatriptan Brain Diseases Serotonin |
Headache Disorders Migraine Disorders Analgesics, Non-Narcotic Headache Analgesics Peripheral Nervous System Agents Acetaminophen |
Serotonin Agonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Central Nervous System Diseases Headache Disorders, Primary Rizatriptan Brain Diseases Pharmacologic Actions |
Headache Disorders Serotonin Agents Migraine Disorders Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Acetaminophen |