Last updated: 11/07/2018 05:21:21
Special Drug Use Investigation for AMERGE® Tablet (Long-term)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
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
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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