Try our beta test site

Drug Use Investigation for IMIGRAN Tablet

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: March 3, 2011
Last updated: June 16, 2011
Last verified: June 2011

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 Intervention
Migraine Disorders
Drug: Sumatriptan

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Drug Use Investigation for IMIGRAN Tablet

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 3571
Study Start Date: September 2001
Study Completion Date: November 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed IMIGRAN
Subjects with migraine disorders prescribed IMIGRAN during study period
Drug: Sumatriptan


Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01376141

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT01376141     History of Changes
Other Study ID Numbers: 112324
Study First Received: March 3, 2011
Last Updated: June 16, 2011

Additional relevant MeSH terms:
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 processed this record on March 29, 2017