Special Drug Use Investigation for AMERGE® Tablet (Long-term)
- Registration Number
- NCT01332383
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Must use AMERGE for the first time
Exclusion Criteria
- Patients with hypersensitivity to naratriptan or any of the components.
- Patients with history, symptoms, or signs of myocardial infarction, ischemic cardiac or angina inversa
- Patients with history of cerebral vascular disturbance or transient ischaemic attack
- Patients with peripheral vascular syndromes
- Patients with uncontrolled hypertension
- Patients with severe renal or hepatic impairment
- Patients using treatment with another 5-HT1 agonist, an ergotamine-containing or ergot-type medication
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients prescribed AMERGE Naratriptan Patients with migraine disorders prescribed AMERGE during study period
- Primary Outcome Measures
Name Time Method The number of adverse drug reactions and serious adverse events 6 months
- Secondary Outcome Measures
Name Time Method