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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00963937 |
Purpose
The purpose of this study is to evaluate the efficacy and safety of a range of doses of oral sumatriptan for the acute treatment of migraine in children ages 10 to 17.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Disorders Migraine |
Drug: Sumatriptan 25 mg Drug: Sumatriptan 50 mg Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents |
| Enrollment: | 178 |
| Study Start Date: | September 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Sumatriptan 25 mg |
Drug: Sumatriptan 25 mg
One Sumatriptan 25mg tablet and one Matching Placebo tablet should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.
|
| Active Comparator: Sumatriptan 50 mg |
Drug: Sumatriptan 50 mg
Two Sumatriptan 25mg tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.
|
| Placebo Comparator: Placebo |
Drug: Placebo
Two Matching Placebo tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.
|
Eligibility| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Note: For the purposes of these criteria, QTc B is defined as (QT interval msec) / (square root of RR interval seconds); and QTc F is defined as (QT interval msec) / (cube root of RR interval seconds).)
Exclusion Criteria:
Contacts and Locations| Japan | |
| GSK Investigational Site | |
| Aichi, Japan, 467-8602 | |
| GSK Investigational Site | |
| Aichi, Japan, 450-0002 | |
| GSK Investigational Site | |
| Hokkaido, Japan, 060-0004 | |
| GSK Investigational Site | |
| Hokkaido, Japan, 060-8570 | |
| GSK Investigational Site | |
| Hyogo, Japan, 658-0064 | |
| GSK Investigational Site | |
| Hyogo, Japan, 663-8204 | |
| GSK Investigational Site | |
| Kagoshima, Japan, 892-0844 | |
| GSK Investigational Site | |
| Kanagawa, Japan, 215-0021 | |
| GSK Investigational Site | |
| Kanagawa, Japan, 252-0375 | |
| GSK Investigational Site | |
| Kanagawa, Japan, 221-0835 | |
| GSK Investigational Site | |
| Kyoto, Japan, 600-8811 | |
| GSK Investigational Site | |
| Osaka, Japan, 560-0012 | |
| GSK Investigational Site | |
| Saitama, Japan, 336-8522 | |
| GSK Investigational Site | |
| Tokyo, Japan, 105-7103 | |
| GSK Investigational Site | |
| Tokyo, Japan, 132-0024 | |
| GSK Investigational Site | |
| Tokyo, Japan, 101-0021 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00963937 History of Changes |
| Other Study ID Numbers: | 111035 |
| Study First Received: | August 20, 2009 |
| Results First Received: | July 28, 2011 |
| Last Updated: | July 28, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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adolescent sumatriptan children migraine |
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Sumatriptan Vasoconstrictor Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |