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

Phase 3

Completed

• Conditions: Migraine Disorders
• Interventions: Drug: Sumatriptan Succinate

• Registration Number: NCT00356603
• Lead Sponsor: GlaxoSmithKline

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

Not available

Study Timeline

• Study Start: 2006-06-20
• Study First Submitted: 2006-07-25
• Study First Submitted QC: 2006-07-25
• Study First Posted: 2006-07-26
• Primary Completion: 2006-08-07
• Study Completion: 2006-08-07
• Results First Submitted: 2017-06-22
• Results First Submitted QC: 2017-11-17
• Results First Posted: 2017-11-20
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-30
• Last Update Posted: 2018-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sumatriptan	Sumatriptan Succinate	Sumatriptan

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate	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.
Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Tokyo, Japan