Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet
- Registration Number
- NCT01376193
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The study is designed to investigate the information on safety and efficacy of naratriptan tablets on Japanese subjects with migraine headache during Japanese post-marketing surveillance period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- Subjects with migraine headache
- Must use naratriptan tablets for the first time
Exclusion Criteria
- Subjects with hypersensitivity to naratriptan
- Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
- Subjects with history of peripheral vascular disorder
- Subjects with history of cerebrovascular disorder or transient ischemic attacks
- Subjects with uncontrolled high-blood pressure
- Subjects with severe hepatic function disorder or renal function disorder
- Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects prescribed naratriptan tablets Naratriptan Subjects with migraine headache prescribed naratriptan tablets during study period
- Primary Outcome Measures
Name Time Method The number of incidence of adverse events in subjects with migraine headache 2 months
- Secondary Outcome Measures
Name Time Method Occurrence of cardiovascular-related adverse events 2 months Occurrence of cardiovascular-related adverse events is investigated throughout study period
Occurrence of cerebrovascular disorder 2 months Occurrence of cerebrovascular disorder is investigated throughout study period
Occurrence of serotonin syndrome 2 months Occurrence of serotonin syndrome is investigated throughout study period