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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 |
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Migraine Disorders |
Drug: rizatriptan benzoate Drug: Comparator : placebo (unspecified) |
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 |
Estimated Enrollment: | 24 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Panel A
Panel A: study medication vs. Pbo
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Drug: rizatriptan benzoate
In Panel A, subjects weighing 20-39 kg will receive a single oral dose of 5 mg dose of rizatriptan ODT. In Panel B, subjects weighing 40 kg and above will receive a single oral dose of 10 mg dose of rizatriptan ODT. Study drug will be administered in the fasted state with the exception that up to 240 mL of Gatorade, Sprite, or A&W Rootbeer may be administered upon waking, but not less than 2 hours prior to dosing, if desired.
Drug: Comparator : placebo (unspecified)
In Panel A, subjects weighing 20-39 kg will receive a single oral dose of placebo (5 mg). In Panel B, subjects weighing 40 kg and above will receive a single oral dose of placebo (10 mg). Study drug will be administered in the fasted state with the exception that up to 240 mL of Gatorade, Sprite, or A&W Rootbeer may be administered upon waking, but not less than 2 hours prior to dosing, if desired.
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Panel B
Panel B: study medication vs. Pbo
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Drug: rizatriptan benzoate
In Panel A, subjects weighing 20-39 kg will receive a single oral dose of 5 mg dose of rizatriptan ODT. In Panel B, subjects weighing 40 kg and above will receive a single oral dose of 10 mg dose of rizatriptan ODT. Study drug will be administered in the fasted state with the exception that up to 240 mL of Gatorade, Sprite, or A&W Rootbeer may be administered upon waking, but not less than 2 hours prior to dosing, if desired.
Drug: Comparator : placebo (unspecified)
In Panel A, subjects weighing 20-39 kg will receive a single oral dose of placebo (5 mg). In Panel B, subjects weighing 40 kg and above will receive a single oral dose of placebo (10 mg). Study drug will be administered in the fasted state with the exception that up to 240 mL of Gatorade, Sprite, or A&W Rootbeer may be administered upon waking, but not less than 2 hours prior to dosing, if desired.
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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 |
Last Updated: | January 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00604812 |
Health Authority: | United States: Food and Drug Administration |
Benzoates Migraine Disorders Headache Central Nervous System Diseases Headache Disorders, Primary |
Rizatriptan Brain Diseases Serotonin Headache Disorders |
Serotonin Agonists Neurotransmitter Agents Serotonin Agents Molecular Mechanisms of Pharmacological Action |
Physiological Effects of Drugs Nervous System Diseases Pharmacologic Actions |