Drug Use Investigation for IMIGRAN Tablet

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01376141
First received: March 3, 2011
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Occurrence of arrhythmia is investigated throughout study period.

  • Occurrence of angina pectoris [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Occurrence of angina pectoris is investigated throughout study period.

  • Occurrence of myocardial infarction [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Genders Eligible for Study:   Both
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.

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
  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 ClinicalTrials.gov identifier: NCT01376141

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01376141     History of Changes
Other Study ID Numbers: 112324
Study First Received: March 3, 2011
Last Updated: June 16, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014