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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.
ClinicalTrials.gov Identifier: NCT01376141
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date March 3, 2011
First Posted Date June 20, 2011
Last Update Posted Date May 22, 2017
Study Start Date September 2001
Actual Primary Completion Date February 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2011)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01376141 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 16, 2011)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Drug Use Investigation for IMIGRAN Tablet
Official Title Drug Use Investigation for IMIGRAN Tablet
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Migraine Disorders
Intervention Drug: Sumatriptan
Study Groups/Cohorts Subjects prescribed IMIGRAN
Subjects with migraine disorders prescribed IMIGRAN during study period
Intervention: Drug: Sumatriptan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 16, 2011)
3571
Original Actual Enrollment Same as current
Actual Study Completion Date November 2005
Actual Primary Completion Date February 2005   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01376141
Other Study ID Numbers 112324
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2017