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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 : September 3, 2018
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
Enrollment 75
Recruitment Details This study was conducted from 20 June 2006 to 07 August 2006 across four centers in Japan.
Pre-assignment Details A total of 75 participants with history of migraine or cluster headache persisting for at least 6 months had entered into the study.
Arm/Group Title Migraine Cluster Headache
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 39 36
Completed 33 33
Not Completed 6 3
Reason Not Completed
Other             6             3
Arm/Group Title Migraine Cluster Headache Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 33 33 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 33 participants 66 participants
41.2  (9.9) 37.4  (9.0) 39.3  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
Female
26
  78.8%
8
  24.2%
34
  51.5%
Male
7
  21.2%
25
  75.8%
32
  48.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 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%
1.Primary Outcome
Title Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache)
Hide Description 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.
Time Frame 30 minutes or 60 Minutes after each administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) Population included patients who self-administered the study product and have at least one efficacy data.
Arm/Group Title Migraine Cluster Headache Migraine + Cluster Headache
Hide Arm/Group Description:
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.
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.
Participants with migraine and 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.
Overall Number of Participants Analyzed 33 33 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
93.9
(79.8 to 99.3)
93.9
(79.8 to 99.3)
93.9
(85.2 to 98.3)
2.Secondary Outcome
Title Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product
Hide Description 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.
Time Frame Up to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population.
Arm/Group Title Migraine Cluster Headache Migraine + Cluster Headache
Hide Arm/Group Description:
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.
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.
Participants with migraine and 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.
Overall Number of Participants Analyzed 33 33 66
Measure Type: Count of Participants
Unit of Measure: Participants
Question 1: Yes
32
  97.0%
33
 100.0%
65
  98.5%
Question 1: No
1
   3.0%
0
   0.0%
1
   1.5%
Question 2: Yes
31
  93.9%
31
  93.9%
62
  93.9%
Question 2: No
2
   6.1%
2
   6.1%
4
   6.1%
Question 3: Yes
31
  93.9%
29
  87.9%
60
  90.9%
Question 3: No
2
   6.1%
4
  12.1%
6
   9.1%
3.Secondary Outcome
Title Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate
Hide Description 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.
Time Frame Up to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population.
Arm/Group Title Migraine Cluster Headache Migraine + Cluster Headache
Hide Arm/Group Description:
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.
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.
Participants with migraine and 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.
Overall Number of Participants Analyzed 33 33 66
Measure Type: Number
Unit of Measure: Percentage of participants
100 100 100
Time Frame All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Adverse Event Reporting Description Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
 
Arm/Group Title Migraine Cluster Headache Migraine + Cluster Headache
Hide Arm/Group Description 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. 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. Participants with migraine and 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.
All-Cause Mortality
Migraine Cluster Headache Migraine + Cluster Headache
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%)   0/66 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Migraine Cluster Headache Migraine + Cluster Headache
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%)   0/66 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Migraine Cluster Headache Migraine + Cluster Headache
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/33 (15.15%)   10/33 (30.30%)   15/66 (22.73%) 
Cardiac disorders       
Palpitations  1  1/33 (3.03%)  0/33 (0.00%)  1/66 (1.52%) 
Gastrointestinal disorders       
Nausea  1  1/33 (3.03%)  2/33 (6.06%)  3/66 (4.55%) 
Abdominal pain upper  1  0/33 (0.00%)  1/33 (3.03%)  1/66 (1.52%) 
Diarrhoea  1  1/33 (3.03%)  0/33 (0.00%)  1/66 (1.52%) 
General disorders       
Malaise  1  1/33 (3.03%)  2/33 (6.06%)  3/66 (4.55%) 
Asthenia  1  1/33 (3.03%)  1/33 (3.03%)  2/66 (3.03%) 
Chest discomfort  1  0/33 (0.00%)  2/33 (6.06%)  2/66 (3.03%) 
Feeling abnormal  1  0/33 (0.00%)  1/33 (3.03%)  1/66 (1.52%) 
Infections and infestations       
Nasopharyngitis  1  1/33 (3.03%)  1/33 (3.03%)  2/66 (3.03%) 
Investigations       
Blood creatine phosphokinase increased  1  0/33 (0.00%)  3/33 (9.09%)  3/66 (4.55%) 
Alanine aminotransferase increased  1  0/33 (0.00%)  1/33 (3.03%)  1/66 (1.52%) 
Aspartate aminotransferase increased  1  0/33 (0.00%)  1/33 (3.03%)  1/66 (1.52%) 
White blood cell count increased  1  0/33 (0.00%)  1/33 (3.03%)  1/66 (1.52%) 
Protein urine present  1  0/33 (0.00%)  1/33 (3.03%)  1/66 (1.52%) 
Nervous system disorders       
Somnolence  1  1/33 (3.03%)  1/33 (3.03%)  2/66 (3.03%) 
Respiratory, thoracic and mediastinal disorders       
Choking sensation  1  0/33 (0.00%)  1/33 (3.03%)  1/66 (1.52%) 
Pharyngeal discomfort  1  0/33 (0.00%)  1/33 (3.03%)  1/66 (1.52%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
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: September 3, 2018