Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Migraine Disorders

Treatments: Drug: Naratriptan

Study type: Observational

Funder types: Industry

Identifiers

NCT01376193

112924

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Subjects prescribed naratriptan tablets

Description:

Subjects with migraine headache prescribed naratriptan tablets during study period

Treatment:

Drug: Naratriptan