Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan - Tabular View

Tracking Information

First Received Date ^ICMJE

July 25, 2006

Last Updated Date

October 13, 2008

Start Date ^ICMJE

June 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Headache Relief at 60 minutes Postdose(Migraine) Headache Relief at 30 minutes Postdose(Cluster Headache) [ Time Frame: 60 Minutes ]

Original Primary Outcome Measures ^ICMJE

Headache Relief at 30 minutes Postdose(Cluster Headache)
Headache Relief at 60 minutes Postdose(Migraine)

Change History

Complete list of historical versions of study NCT00356603 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Subject acceptability of the sumatriptan 3mg kit product Rate of successful self-injection of the sumatriptan 3mg kit product

Original Secondary Outcome Measures ^ICMJE

Subject acceptability of the sumatriptan 3mg kit product
Rate of successful self-injection of the sumatriptan 3mg kit product

Descriptive Information

Brief Title ^ICMJE

Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan

Official Title ^ICMJE

Clinical Evaluation of Sumatriptan Succinate Injection Kit Product in Patients With Migraine or Cluster Headache

Brief Summary

This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg kit product for the treatment of migraine or cluster headache attacks in clinical settings, to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness) and rate of successful self-injection.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Migraine
Cluster Headache

Intervention ^ICMJE

Drug: Sumatriptan Succinate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

August 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Diagnosis of migraine (with or without aura) or cluster headache according to the International Classification of Headache Disorders, Version 2 (ICHD-II)
History of migraine or cluster headache persisting for at least 6 months
Migraine: One to 6 attacks of moderate or severer headaches per month during the 2 months prior to enrollment
Cluster Headache: Each attack persisting for at least 45 minutes
Written informed consent obtained from the patient. When a patient is a minor, written informed consent from his/her proxy consenter (e.g., person with parental authority) will also be required.

Exclusion criteria:

History of hypersensitivity to any of the ingredients of 5-HT1B/1D receptor antagonists (e.g., triptans) or serious AE due to treatment with these drugs
History of serious adverse event attributable to treatment with Imigran® Injection 3
History of myocardial infarction, current or previous history of ischemic heart disease or its symptoms/signs, or current history of atypical variant angina (coronary arteriospasm)
Previous history of cerebrovascular disorder or transient cerebral ischemic attack
Current or previous history of peripheral angiopathy (including Raynaud's syndrome)
Systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >95 mmHg at the start of treatment period
Current familial hemiplegic migraine, basilar migraine, or sporadic hemiplegic migraine
Current abuse of ergotamine- or dihydroergotamine-containing preparations or triptans
Pregnant women, lactating mothers, women who may be pregnant, or women of childbearing potential using no appropriate contraceptive measures.
Epilepsy or organic cerebral disorder which may lead to convulsion
Previous history of hypersensitivity to sulfonamides
Known drug allergy or idiosyncrasies
Known drug dependency or alcoholism

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00356603

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

STA106711

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP