Special Drug Use Investigation for AMERGE® Tablet (Long-term)
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Disorders
Intervention: Naratriptan (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on
Japanese patients with migraine headache in clinical setting
Clinical Details
Official title: Special Drug Use Investigation for AMERGE Tablet (Long-term)
Study design: Time Perspective: Prospective
Primary outcome: The number of adverse drug reactions and serious adverse events
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: May 2009
Last updated: August 10, 2015
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