Drug Use Investigation for IMIGRAN Tablet
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|ClinicalTrials.gov Identifier: NCT01376141|
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : May 22, 2017
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.
|Condition or disease||Intervention/treatment|
|Migraine Disorders||Drug: Sumatriptan|
|Study Type :||Observational|
|Actual Enrollment :||3571 participants|
|Official Title:||Drug Use Investigation for IMIGRAN Tablet|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||February 2005|
|Actual Study Completion Date :||November 2005|
Subjects prescribed IMIGRAN
Subjects with migraine disorders prescribed IMIGRAN during study period
- The number of incidence of adverse events in subjects with migraine disorders [ Time Frame: 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
- Occurrence of arrhythmia [ Time Frame: 2 months ]Occurrence of arrhythmia is investigated throughout study period.
- Occurrence of angina pectoris [ Time Frame: 2 months ]Occurrence of angina pectoris is investigated throughout study period.
- Occurrence of myocardial infarction [ Time Frame: 2 months ]Occurrence of myocardial infarction is investigated throughout study period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376141
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|