|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
Drug: Sumatriptan 50 mg Drug: Sumatriptan 25 mg Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 166 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Sumatriptan 25 mg: Active Comparator |
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.
|
| Sumatriptan 50 mg: Active Comparator |
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: Placebo Comparator |
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| Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
| Japan | |
| GSK Investigational Site | Not yet recruiting |
| Hokkaido, Japan, 060-8570 | |
| Principal Investigator: Atsuko Nihira | |
| GSK Investigational Site | Recruiting |
| Hyogo, Japan, 658-0064 | |
| Principal Investigator: Shigekazu Kitamura | |
| GSK Investigational Site | Recruiting |
| Tokyo, Japan, 105-7103 | |
| Principal Investigator: Yoshitaka Watanabe | |
| GSK Investigational Site | Recruiting |
| Kyoto, Japan, 600-8811 | |
| Principal Investigator: Yoshihisa Tatsuoka | |
| GSK Investigational Site | Recruiting |
| Tokyo, Japan, 132-0024 | |
| Principal Investigator: Shigeyuki Murakami | |
| GSK Investigational Site | Recruiting |
| Aichi, Japan, 450-0002 | |
| Principal Investigator: Jun Teramoto | |
| GSK Investigational Site | Not yet recruiting |
| Kanagawa, Japan, 221-0835 | |
| Principal Investigator: Hisaka Igarashi | |
| GSK Investigational Site | Not yet recruiting |
| Aichi, Japan, 467-8602 | |
| Principal Investigator: Naoki Ando | |
| GSK Investigational Site | Recruiting |
| Hyogo, Japan, 663-8204 | |
| Principal Investigator: Michio Yamaguchi | |
| GSK Investigational Site | Recruiting |
| Hokkaido, Japan, 060-0004 | |
| Principal Investigator: Kouichi Kitami | |
| GSK Investigational Site | Recruiting |
| Kagoshima, Japan, 892-0844 | |
| Principal Investigator: Shigeya Tanaka | |
| GSK Investigational Site | Not yet recruiting |
| Kanagawa, Japan, 215-0021 | |
| Principal Investigator: Fumihiko Sakai | |
| GSK Investigational Site | Not yet recruiting |
| Saitama, Japan, 336-8522 | |
| Principal Investigator: Kiyoshi Araki | |
| GSK Investigational Site | Not yet recruiting |
| Tokyo, Japan, 101-0021 | |
| Principal Investigator: Kiyoshi Owada | |
| GSK Investigational Site | Recruiting |
| Osaka, Japan, 560-0012 | |
| Principal Investigator: Yasushi Takase | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 111035 |
| Study First Received: | August 20, 2009 |
| Last Updated: | February 4, 2010 |
| ClinicalTrials.gov Identifier: | NCT00963937 History of Changes |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
sumatriptan children adolescent migraine |
|
Serotonin Agonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Headache Disorders, Primary Cardiovascular Agents |
Brain Diseases Pharmacologic Actions Headache Disorders Sumatriptan Serotonin Agents Migraine Disorders Therapeutic Uses Vasoconstrictor Agents |