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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00662818 |
The purpose of this study is to evaluate the safety and efficacy of MK0974 in the treatment of acute migraine in patients with stable vascular disease.
Condition | Intervention | Phase |
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Migraine Disorders Heart Disease Cerebrovascular Accident TIA (Transient Ischemic Attack) Vascular Diseases Peripheral Vascular Diseases |
Drug: MK0974 Drug: Comparator: acetaminophen Drug: Comparator: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo- and Active Controlled, Crossover Study to Evaluate the Safety and Efficacy of MK0974 in the Treatment of Acute Migraine in Patients With Stable Vascular Disease |
Estimated Enrollment: | 400 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | September 2009 |
Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Crossover study: All migraine attacks to be treated with up to 12 doses of MK0974 over the 1st six week treatment period. This will be followed by up to 12 doses of acetaminophen/paracetamol (1000mg dry filled capsules) over the 2nd six week treatment period.
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Drug: MK0974
MK0974 (300mg soft gel capsules)
Drug: Comparator: acetaminophen
acetaminophen (1000mg dry filled capsules)
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2: Active Comparator
Crossover study: All migraine attacks to be treated with one dose of placebo and up to 11 doses of acetaminophen over the 1st six week treatment period. This will be followed by up to 12 doses of MK0974 over the 2nd six week treatment period.
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Drug: MK0974
MK0974 (300mg soft gel capsules)
Drug: Comparator: acetaminophen
acetaminophen (1000mg dry filled capsules)
Drug: Comparator: Placebo
placebo (0mg soft gel capsules)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2007_545, MK0974-034 |
Study First Received: | April 17, 2008 |
Last Updated: | September 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00662818 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Ischemic Attack, Transient Heart Diseases Peripheral Vascular Diseases Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Headache Disorders, Primary Ischemia Brain Diseases Cerebrovascular Disorders |
Headache Disorders Analgesics, Non-Narcotic Migraine Disorders Headache Brain Ischemia Peripheral Nervous System Agents Analgesics Brain Infarction Infarction Acetaminophen |
Cerebral Infarction Physiological Effects of Drugs Headache Disorders, Primary Brain Diseases Cerebrovascular Disorders Headache Disorders Migraine Disorders Sensory System Agents Therapeutic Uses Brain Ischemia Cardiovascular Diseases Analgesics Acetaminophen |
Ischemic Attack, Transient Peripheral Vascular Diseases Heart Diseases Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases Pharmacologic Actions Analgesics, Non-Narcotic Brain Infarction Peripheral Nervous System Agents Central Nervous System Agents |