Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet

Migraine Disorders Clinical Trial

Official title:

Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376193
• Other study ID #: 112924
• Status: Completed
• Phase: N/A
• First received: June 9, 2011
• Last updated: May 16, 2013
• Start date: April 2009
• Est. completion date: October 2011

Study information

• Verified date: May 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• Naratriptan
Collection of safety data

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (1)

Takao Takeshima, Atsuko Ishida, Terufumi Hara. Drug Use Investigation on Naratriptan Tablets (Amerge®) in Patients with Migraine. [Prog Med]. 2012;32(8):95-105.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of incidence of adverse events in subjects with migraine headache		2 months	Yes
Secondary	Occurrence of cardiovascular-related adverse events	Occurrence of cardiovascular-related adverse events is investigated throughout study period	2 months	Yes
Secondary	Occurrence of cerebrovascular disorder	Occurrence of cerebrovascular disorder is investigated throughout study period	2 months	Yes
Secondary	Occurrence of serotonin syndrome	Occurrence of serotonin syndrome is investigated throughout study period	2 months	Yes