Drug Use Investigation for IMIGRAN Tablet

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01376141

Enrollment

3571

Registered

2011-06-20

Start date

2001-09-30

Completion date

2005-11-30

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Disorders

Brief 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.

Interventions

DRUGSumatriptan

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
The number of incidence of adverse events in subjects with migraine disorders	2 months	Adverse event (AE), diagnosis or symptom, date of onset, outcome, date of outcome, seriousness, reason for judgement of serious, intensity, relationship to IMIGRAN, other factors suspected to have relationship to AE

Secondary

Measure	Time frame	Description
Occurrence of arrhythmia	2 months	Occurrence of arrhythmia is investigated throughout study period.
Occurrence of angina pectoris	2 months	Occurrence of angina pectoris is investigated throughout study period.
Occurrence of myocardial infarction	2 months	Occurrence of myocardial infarction is investigated throughout study period.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026