Drug Use Investigation for IMIGRAN Tablet
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Drug Use Investigation for IMIGRAN Tablet|
- The number of incidence of adverse events in subjects with migraine disorders [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Occurrence of arrhythmia is investigated throughout study period.
- Occurrence of angina pectoris [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]Occurrence of angina pectoris is investigated throughout study period.
- Occurrence of myocardial infarction [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]Occurrence of myocardial infarction is investigated throughout study period.
|Study Start Date:||September 2001|
|Study Completion Date:||November 2005|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
Subjects prescribed IMIGRAN
Subjects with migraine disorders prescribed IMIGRAN during study period
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376141
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|