Drug Use Investigation for IMIGRAN Tablet

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to detect adverse drug reactions (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy of sumatriptan tablet, and to discuss the need of special investigation and postmarketing clinical study.

A special focus was placed on the investigation of occurrence of "ischaemic heart disease-like events including arrhythmia, angina pectoris, and myocardial infarction" in the present study.

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Sumatriptan

Criteria

Inclusion Criteria:

• Subjects with migraine disorders

Exclusion Criteria:

• Subjects with hypersensitivity to sumatriptan

• 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

• Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist

• Subjects taking monoamine oxidaze inhibitor or use within 2 weeks of discontinuation