Last updated: 11/03/2018 12:52:46
Drug Use Investigation for IMIGRAN Tablet
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Drug Use Investigation for IMIGRAN Tablet
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of incidence of adverse events in subjects with migraine disorders
Timeframe: 2 months
Secondary outcomes:
Occurrence of arrhythmia
Timeframe: 2 months
Occurrence of angina pectoris
Timeframe: 2 months
Occurrence of myocardial infarction
Timeframe: 2 months
Interventions:
Drug: Sumatriptan
Enrollment:
3571
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Migraine Disorders
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
September 2001 to June 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
None
- Subjects with migraine disorders
- Subjects with hypersensitivity to sumatriptan
- Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
Inclusion and exclusion 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
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2011-20-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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