Drug Use Investigation for IMIGRAN Tablet

Migraine Disorders Clinical Trial

Official title:

Drug Use Investigation for IMIGRAN Tablet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376141
• Other study ID #: 112324
• Status: Completed
• Phase: N/A
• First received: March 3, 2011
• Last updated: May 19, 2017
• Start date: September 2001
• Est. completion date: November 2005

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3571
• Est. completion date: November 2005
• Est. primary completion date: February 2005
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• Sumatriptan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of incidence of adverse events in subjects with migraine disorders	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	2 months
Secondary	Occurrence of arrhythmia	Occurrence of arrhythmia is investigated throughout study period.	2 months
Secondary	Occurrence of angina pectoris	Occurrence of angina pectoris is investigated throughout study period.	2 months
Secondary	Occurrence of myocardial infarction	Occurrence of myocardial infarction is investigated throughout study period.	2 months