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Drug Use Investigation for IMIGRAN Tablet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01376141
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : May 22, 2017
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment
Migraine Disorders Drug: Sumatriptan

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Study Type : Observational
Actual Enrollment : 3571 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Group/Cohort Intervention/treatment
Subjects prescribed IMIGRAN
Subjects with migraine disorders prescribed IMIGRAN during study period
Drug: Sumatriptan

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Occurrence of arrhythmia [ Time Frame: 2 months ]
    Occurrence of arrhythmia is investigated throughout study period.

  2. Occurrence of angina pectoris [ Time Frame: 2 months ]
    Occurrence of angina pectoris is investigated throughout study period.

  3. Occurrence of myocardial infarction [ Time Frame: 2 months ]
    Occurrence of myocardial infarction is investigated throughout study period.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Male and female Japanese subjects with migraine disorders who were considered appropriate to prescribe sumatriptan tablet according to the prescribing information were eligible for this surveillance study.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01376141

Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline Identifier: NCT01376141    
Other Study ID Numbers: 112324
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs