Last updated: 11/07/2018 05:21:21

Special Drug Use Investigation for AMERGE® Tablet (Long-term)

GSK study ID
112925
See study documents
Clinicaltrials.gov ID
NCT01332383
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: Special Drug Use Investigation for AMERGE Tablet (Long-term)
Trial description: To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The number of adverse drug reactions and serious adverse events

Timeframe: 6 months

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Naratriptan
    • Enrollment:
    300
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Takao Takeshima, Atsuko Ishida, Terufumi Hara.Special Drug Use Investigation Aimed at Assessment of Safety and Effectiveness in Long-Term Use of Naratriptan (Amerge® Tablets) in Migraine Patients (Final Results).Prog Med.2014;34(10):145-154
    Medical condition
    Migraine Disorders
    Product
    naratriptan
    Collaborators
    Not applicable
    Study date(s)
    May 2009 to October 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Must use AMERGE for the first time
    • Patients with hypersensitivity to naratriptan or any of the components.
    • Patients with history, symptoms, or signs of myocardial infarction, ischemic cardiac or angina inversa
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Must use AMERGE for the first time
    Exclusion criteria:
    • Patients with hypersensitivity to naratriptan or any of the components.
    • Patients with history, symptoms, or signs of myocardial infarction, ischemic cardiac or angina inversa
    • Patients with history of cerebral vascular disturbance or transient ischaemic attack
    • Patients with peripheral vascular syndromes
    • Patients with uncontrolled hypertension
    • Patients with severe renal or hepatic impairment
    • Patients using treatment with another 5-HT1 agonist, an ergotamine-containing or ergot-type medication

    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
    2013-31-10

    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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