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OpenTrials
Completed

NCT Number: NCT01376193

Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet

The study is designed to investigate the information on safety and efficacy of naratriptan tablets on Japanese subjects with migraine headache during Japanese post-marketing surveillance period.

Completed

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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

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with migraine headache
  • Must use naratriptan tablets for the first time

Exclusion criteria

  • Subjects with hypersensitivity to naratriptan
  • 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 or renal function disorder
  • Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist

Treatment and study plan

Naratriptan

Drug

Collection of safety data

Primary outcomes

  1. The number of incidence of adverse events in subjects with migraine headache

    Time frame: 2 months

Secondary outcomes

  1. Occurrence of cardiovascular-related adverse events

    Time frame: 2 months

    Occurrence of cardiovascular-related adverse events is investigated throughout study period

  2. Occurrence of cerebrovascular disorder

    Time frame: 2 months

    Occurrence of cerebrovascular disorder is investigated throughout study period

  3. Occurrence of serotonin syndrome

    Time frame: 2 months

    Occurrence of serotonin syndrome is investigated throughout study period

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 20, 2011
Registry last updated
May 20, 2013

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.

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