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

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ClinicalTrials.gov Identifier: NCT00356603
Recruitment Status : Completed
First Posted : July 26, 2006
Results First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Migraine Disorders
Intervention: Drug: Sumatriptan Succinate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted from 20 June 2006 to 07 August 2006 across four centers in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 75 participants with history of migraine or cluster headache persisting for at least 6 months had entered into the study.

Reporting Groups
  Description
Migraine Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 milligrams (mg) kit product (0.5 milliliter [mL] containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
Cluster Headache Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.

Participant Flow:   Overall Study
    Migraine   Cluster Headache
STARTED   39   36 
COMPLETED   33   33 
NOT COMPLETED   6   3 
Other                6                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Migraine Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
Cluster Headache Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
Total Total of all reporting groups

Baseline Measures
   Migraine   Cluster Headache   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   33   66 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.2  (9.9)   37.4  (9.0)   39.3  (9.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      26  78.8%      8  24.2%      34  51.5% 
Male      7  21.2%      25  75.8%      32  48.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      33 100.0%      33 100.0%      66 100.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      0   0.0%      0   0.0%      0   0.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product   [ Time Frame: Up to 2 months ]

3.  Secondary:   Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate   [ Time Frame: Up to 2 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00356603     History of Changes
Other Study ID Numbers: STA106711
First Submitted: July 25, 2006
First Posted: July 26, 2006
Results First Submitted: June 22, 2017
Results First Posted: November 20, 2017
Last Update Posted: November 20, 2017