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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00356603 |
Purpose
This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg kit product for the treatment of migraine or cluster headache attacks in clinical settings, to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness) and rate of successful self-injection.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Cluster Headache |
Drug: Sumatriptan Succinate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Evaluation of Sumatriptan Succinate Injection Kit Product in Patients With Migraine or Cluster Headache |
| Enrollment: | 75 |
| Study Start Date: | June 2006 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| Japan | |
| GSK Investigational Site | |
| Aichi, Japan, 450-0002 | |
| GSK Investigational Site | |
| Hyogo, Japan, 663-8204 | |
| GSK Investigational Site | |
| Kyoto, Japan, 600-8811 | |
| GSK Investigational Site | |
| Tokyo, Japan, 105-7103 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00356603 History of Changes |
| Other Study ID Numbers: | STA106711 |
| Study First Received: | July 25, 2006 |
| Last Updated: | March 25, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
Sumatriptan Succinate Injection Kit Migraine Cluster Headache self-injection |
|
Cluster Headache Headache Migraine Disorders Trigeminal Autonomic Cephalalgias Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms |
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 |