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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00356603
First Posted: July 26, 2006
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
July 25, 2006
July 26, 2006
June 22, 2017
November 20, 2017
November 20, 2017
June 20, 2006
August 7, 2006   (Final data collection date for primary outcome measure)
Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache) [ Time Frame: 30 minutes or 60 Minutes after each administration ]
Headache relief rate was the percentage of participants who showed effectiveness 60 minutes post dose (migraine) or 30 minutes post dose (cluster headache). Data for participants with percentage effectiveness along with 95% confidence interval has been presented.
  • Headache Relief at 60 minutes Postdose(Migraine)
  • Headache Relief at 30 minutes Postdose(Cluster Headache)
Complete list of historical versions of study NCT00356603 on ClinicalTrials.gov Archive Site
  • Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product [ Time Frame: Up to 2 months ]
    The subject-rated acceptability of sumatriptan succinate injection 3 mg kit product had three questions, question 1 was "Was the kit product easy to use?", question 2 was "Do you want to use the kit product in the future?" and question 3 was "Do you consider that the kit product is necessary for the treatment of your illness?". The responses were given as yes or no. Data for number of participants who responded to the three questions as yes or no has been presented.
  • Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate [ Time Frame: Up to 2 months ]
    The investigator/sub investigator-rated successful self-injection rate was the percentage of participants who were able to use the kit as directed by the investigator/ sub investigator. The response was given as yes or no. Data for percentage of participants who were actually able to use the kit as directed has been presented.
  • 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
Imigran STATdose - Japan Clinical Experience Study for Self-injection
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Migraine Disorders
Drug: Sumatriptan Succinate
Sumatriptan Succinate
Experimental: Sumatriptan
Sumatriptan
Intervention: Drug: Sumatriptan Succinate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
August 7, 2006
August 7, 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00356603
STA106711
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2017

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