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NCT01332383 Clinical Trial

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

Migraine Disorders Clinical Trial

Official title:
Special Drug Use Investigation for AMERGE Tablet (Long-term)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01332383
Other study ID # 112925
Secondary ID
Status Completed
Phase N/A
First received April 7, 2011
Last updated August 10, 2015
Start date May 2009
Est. completion date October 2013

Study information
Verified date August 2015
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Naratriptan

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary The number of adverse drug reactions and serious adverse events 6 months Yes
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