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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00604812 |
A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines
Condition | Intervention | Phase |
---|---|---|
Migraine Disorders |
Drug: rizatriptan benzoate (5 mg) Drug: rizatriptan benzoate (10 mg) Drug: Comparator: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Single-Dose Pharmacokinetics of MK0462 in Subjects With Migraines Aged 6 to 17 Years |
Enrollment: | 24 |
Study Start Date: | December 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Panel A Rizatriptan: Experimental
Rizatriptan 5 mg
|
Drug: rizatriptan benzoate (5 mg) |
Panel A Placebo: Placebo Comparator
placebo
|
Drug: Comparator: Placebo |
Panel B Rizatriptan: Experimental
Rizatriptan 10 mg
|
Drug: rizatriptan benzoate (10 mg) |
Panel B Placebo: Placebo Comparator
placebo
|
Drug: Comparator: Placebo |
Ages Eligible for Study: | 6 Years to 17 Years |
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_601, MK0462-083 |
Study First Received: | October 17, 2007 |
Results First Received: | June 3, 2009 |
Last Updated: | September 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00604812 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Serotonin Agonists Anti-Infective Agents Neurotransmitter Agents Benzoates Central Nervous System Diseases Headache Disorders, Primary Rizatriptan |
Brain Diseases Serotonin Headache Disorders Migraine Disorders Antifungal Agents Headache |
Serotonin Agonists Anti-Infective Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Benzoates Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Headache Disorders, Primary |
Rizatriptan Brain Diseases Pharmacologic Actions Headache Disorders Serotonin Agents Migraine Disorders Therapeutic Uses Antifungal Agents |