Last updated: 11/03/2018 13:50:48
Drug Use Investigation for AMERGE (naratriptan hydrochloride) Tablet
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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