Last updated: 11/03/2018 12:52:46

Drug Use Investigation for IMIGRAN Tablet

GSK study ID
112324
See study documents
Clinicaltrials.gov ID
NCT01376141
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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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