Drug Use Investigation for IMIGRAN Tablet

NCT01376141 | Completed

• 1 other identifier: 112324
• Study Type: observational
• Target: 3,571
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• The number of incidence of adverse events in subjects with migraine disorders

  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

  2 months

Secondary Outcomes (3)

• Occurrence of arrhythmia

  2 months

• Occurrence of angina pectoris

  2 months

• Occurrence of myocardial infarction

  2 months

Study Arms (1)

Subjects prescribed IMIGRAN

Subjects with migraine disorders prescribed IMIGRAN during study period

Drug: Sumatriptan

Interventions

Sumatriptan DRUG

Subjects prescribed IMIGRAN

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects with migraine disorders

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: June 20, 2011
• Study Start: September 1, 2001
• Primary Completion: February 1, 2005
• Study Completion: November 1, 2005
• Last Updated: May 22, 2017

Record last verified: 2017-05