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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00356603
First received: July 25, 2006
Last updated: May 13, 2013
Last verified: May 2013

July 25, 2006
May 13, 2013
June 2006
August 2006   (final data collection date for primary outcome measure)
Headache Relief at 60 minutes Postdose(Migraine) Headache Relief at 30 minutes Postdose(Cluster Headache) [ Time Frame: 60 Minutes ]
  • Headache Relief at 30 minutes Postdose(Cluster Headache)
  • Headache Relief at 60 minutes Postdose(Migraine)
Complete list of historical versions of study NCT00356603 on ClinicalTrials.gov Archive Site
Subject acceptability of the sumatriptan 3mg kit product Rate of successful self-injection of the sumatriptan 3mg kit product
  • Subject acceptability of the sumatriptan 3mg kit product
  • Rate of successful self-injection of the sumatriptan 3mg kit product
Not Provided
Not Provided
 
Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
Clinical Evaluation of Sumatriptan Succinate Injection Kit Product in Patients With Migraine or Cluster Headache

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Migraine Disorders
  • Cluster Headache
  • Migraine
Drug: Sumatriptan Succinate
Other Name: Sumatriptan Succinate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2006
August 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00356603
STA106711
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2013

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