Drug Use Investigation for AMERGE (Naratriptan Hydrochlor... | NCT01376193

Studies
Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet

NCT01376193

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

May 20, 2013Estimated

Enrollment

500Actual

Phase

Not provided

Conditions

Migraine Disorders

Interventions

Naratriptan

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Jun 9, 2011

First Submission Date that Met QC Criteria

Jun 16, 2011

First Posted Date

Jun 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2013

Last Update Posted Date

May 20, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects prescribed naratriptan tablets		Subjects with migraine headache prescribed naratriptan tablets during study period	Drug: Naratriptan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Naratriptan	Drug	Collection of safety data	Subjects prescribed naratriptan tablets

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of incidence of adverse events in subjects with migraine headache		2 months

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of cardiovascular-related adverse events	Occurrence of cardiovascular-related adverse events is investigated throughout study period	2 months
Occurrence of cerebrovascular disorder

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Japanese subjects with migraine headache

Sampling Method

Probability Sample

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

References Module

Citations

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

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases