Last updated: 11/03/2018 13:50:48

Drug Use Investigation for AMERGE (naratriptan hydrochloride) Tablet

GSK study ID
112924
See study documents
Clinicaltrials.gov ID
NCT01376193
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Drug Use Investigation for AMERGE (naratriptan hydrochloride) Tablet
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: 2 months

Secondary outcomes:

Occurrence of cardiovascular-related adverse events

Timeframe: 2 months

Occurrence of cerebrovascular disorder

Timeframe: 2 months

Occurrence of serotonin syndrome

Timeframe: 2 months

Interventions:
  • Drug: Naratriptan
    • Enrollment:
    500
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Takao Takeshima, Atsuko Ishida, Terufumi Hara. Drug Use Investigation on Naratriptan Tablets (Amerge®) in Patients with Migraine. [Prog Med]. 2012;32(8):95-105.
    Medical condition
    Migraine Disorders
    Product
    naratriptan
    Collaborators
    Not applicable
    Study date(s)
    April 2009 to May 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • Subjects with migraine headache
    • Must use naratriptan tablets for the first time
    • Subjects with hypersensitivity to naratriptan
    • Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
    Inclusion and exclusion criteria
    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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2012-11-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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