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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Migraine Disorders

Treatments: Drug: Naratriptan

Study type: Observational

Funder types: Industry

Identifiers

NCT01332383

112925

Details and patient eligibility

About

To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting

Enrollment: 300 patients

Sex: All

Volunteers: No Healthy Volunteers

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 design

300 participants in 1 patient group

Patients prescribed AMERGE

Description:

Patients with migraine disorders prescribed AMERGE during study period

Treatment:

Drug: Naratriptan