Skip to main content
OpenTrials
Completed

NCT Number: NCT01376141

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sumatriptan

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Jun 20, 2011
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.