Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Migraine Study in Adolescent Patients

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.
ClinicalTrials.gov Identifier: NCT00843024
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : May 9, 2011
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine Disorders
Interventions Drug: Sumatriptan and Naproxen Sodium
Drug: Placebo
Enrollment 589
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 12 to 14 Years Age Group: Single-blind Phase 15 to 17 Years Age Group: Single-blind Phase Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg
Hide Arm/Group Description Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of single-blind placebo within a 12-week period. After completion of the run-in phase, participants were randomized to one of four double-blind treatment groups. Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of single-blind placebo within a 12-week period. After completion of the run-in phase, participants were randomized to one of four double-blind treatment groups. After completing the single-blind phase, participants received a single matching placebo tablet taken within a 12-week period After completing the single-blind phase, participants received a single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period After completing the single-blind phase, participants received a single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period After completing the single-blind phase, participants received a single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
Period Title: Single-blind Placebo Run-In Phase
Started 408 457 0 0 0 0
Completed 268 321 0 0 0 0
Not Completed 140 136 0 0 0 0
Reason Not Completed
Did not meet continuation criteria             79             74             0             0             0             0
Lost to Follow-up             36             31             0             0             0             0
Withdrawal by Subject             19             18             0             0             0             0
Protocol Violation             4             5             0             0             0             0
Physician Decision             2             6             0             0             0             0
Adverse Event             0             1             0             0             0             0
Other             0             1             0             0             0             0
Period Title: Double-blind Treatment Phase
Started 0 0 176 119 117 177
Completed 0 0 145 96 97 152
Not Completed 0 0 31 23 20 25
Reason Not Completed
No opportunity to treat migraine             0             0             20             10             13             14
Lost to Follow-up             0             0             8             4             4             4
Withdrawal by Subject             0             0             0             6             0             2
Protocol Violation             0             0             3             0             0             3
Physician Decision             0             0             0             3             1             1
Adverse Event             0             0             0             0             1             1
Lack of Efficacy             0             0             0             0             1             0
Arm/Group Title Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg Total
Hide Arm/Group Description A single matching placebo tablet taken within a 12-week period A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period Total of all reporting groups
Overall Number of Baseline Participants 145 96 97 152 490
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 96 participants 97 participants 152 participants 490 participants
14.7  (1.76) 14.8  (1.81) 14.7  (1.65) 14.8  (1.69) 14.7  (1.72)
[1]
Measure Description: Baseline characteristics are provided for participants in the Intent-to-Treat (ITT) Population, comprised of all participants who provided any post-treatment efficacy assessment.
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 96 participants 97 participants 152 participants 490 participants
Female
85
  58.6%
52
  54.2%
56
  57.7%
94
  61.8%
287
  58.6%
Male
60
  41.4%
44
  45.8%
41
  42.3%
58
  38.2%
203
  41.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 145 participants 96 participants 97 participants 152 participants 490 participants
African American/African Heritage 25 17 9 12 63
American Indian or Alaska Native 0 0 0 1 1
Asian 1 0 0 3 4
Native Hawaiian or other Pacific Islander 1 0 0 0 1
White 108 75 84 130 397
African American/African Heritage and White 2 1 1 2 6
American Indian or Alaska Native and White 1 2 2 3 8
Asian and Native Hawaiian/other Pacific Islander 1 0 0 0 1
Asian and White 3 1 0 1 5
Native Hawaiian/ other Pacific Islander and White 1 0 1 0 2
Missing 2 0 0 0 2
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 145 participants 96 participants 97 participants 152 participants 490 participants
63.8  (16.67) 64.2  (19.29) 62.8  (14.49) 66.8  (19.13) 64.6  (17.63)
Body Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms per meters squared (kg/m^2)
Number Analyzed 145 participants 96 participants 97 participants 152 participants 490 participants
23.5  (5.28) 23.3  (5.62) 22.9  (4.53) 24.6  (5.68) 23.7  (5.36)
[1]
Measure Description: Body Mass Index is calculated as: weight (kg)/height (m^2)
1.Primary Outcome
Title Number of Participants Who Were Pain Free at 2 Hours Post-dose
Hide Description Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose.
Time Frame 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: participants who took a dose of double-blind randomized treatment and provided some assessment of their migraine pain or associated symptoms. Participants were not included in this analysis if their baseline pain was not moderate or severe, or if they had no post-baseline evaluation of pain up to the time point analyzed.
Arm/Group Title Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg
Hide Arm/Group Description:
A single matching placebo tablet taken within a 12-week period
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
Overall Number of Participants Analyzed 142 96 97 150
Measure Type: Number
Unit of Measure: participants
Total Population, n=142, 96, 97, 150 14 28 26 36
12-14 years, n=70, 43, 46, 65 10 18 13 17
15-17 years, n=72, 53, 51, 85 4 10 13 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sumatriptan 10 mg/ Naproxen 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Adjusted for multiplicity according to the fixed sequence testing strategy
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
0.09 to 0.30
Estimation Comments Sumatriptan 10 mg/Naproxen 60 mg minus placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sumatriptan 30 mg/ Naproxen 180 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Adjusted for multiplicity according to the fixed-sequence testing strategy
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
0.07 to 0.26
Estimation Comments Sumatriptan 30 mg/Naproxen180 mg minus placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Sumatriptan 85 mg/ Naproxen 500 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Adjusted for multiplicity according to the fixed-sequence testing strategy
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
0.05 to 0.22
Estimation Comments Sumatriptan 85 mg/Naproxen 500 mg minus placebo
2.Secondary Outcome
Title Number of Participants Sustained Pain-free From 2-24 Hours
Hide Description Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication.
Time Frame 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
Arm/Group Title Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg
Hide Arm/Group Description:
A single matching placebo tablet taken within a 12-week period
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
Overall Number of Participants Analyzed 142 96 97 150
Measure Type: Number
Unit of Measure: participants
Total Population, n=142, 96, 97, 150 13 23 24 35
12-14 years, n=70, 43, 46, 65 10 14 12 17
15-17 years, n=72, 53, 51, 85 3 9 12 18
3.Secondary Outcome
Title Number of Participants Photophobia-free at 2 Hours Post-dose
Hide Description The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed.
Time Frame 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
Arm/Group Title Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg
Hide Arm/Group Description:
A single matching placebo tablet taken within a 12-week period
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
Overall Number of Participants Analyzed 144 96 96 151
Measure Type: Number
Unit of Measure: participants
Total Population, n=144, 96, 96, 151 59 57 47 89
12-14 years, n=71, 43, 46, 65 33 29 24 41
15-17 years, n=73, 53, 50, 86 26 28 23 48
4.Secondary Outcome
Title Number of Participants Phonophobia-free at 2 Hours Post-dose
Hide Description The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed.
Time Frame 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
Arm/Group Title Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg
Hide Arm/Group Description:
A single matching placebo tablet taken within a 12-week period
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
Overall Number of Participants Analyzed 144 96 96 151
Measure Type: Number
Unit of Measure: participants
Total Population, n=144, 96, 96, 151 60 59 55 90
12-14 years, n=71, 43, 46, 65 34 32 33 41
15-17 years, n=73, 53, 50, 86 26 47 22 49
5.Secondary Outcome
Title Number of Participants Pain-free at 1 Hour Post-dose
Hide Description Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose.
Time Frame 1 hour after single dose of double-blind treatment (Randomization through Week 13)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
Arm/Group Title Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg
Hide Arm/Group Description:
A single matching placebo tablet taken within a 12-week period
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
Overall Number of Participants Analyzed 142 96 97 150
Measure Type: Number
Unit of Measure: participants
Total Population, n=142, 96, 97, 150 6 9 6 11
12-14 years, n=70, 43, 46, 65 4 7 2 4
15-17 years, n=72, 53, 51, 85 2 2 4 7
6.Secondary Outcome
Title Number of Participants Sustained Photophobia-free From 2-24 Hours
Hide Description Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication.
Time Frame 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
Arm/Group Title Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg
Hide Arm/Group Description:
A single matching placebo tablet taken within a 12-week period
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
Overall Number of Participants Analyzed 144 96 96 151
Measure Type: Number
Unit of Measure: participants
Total Population, n=144, 96, 96, 151 44 48 43 75
12-14 years, n=71, 43, 46, 65 25 21 21 35
15-17 years, n=73, 53, 50, 86 19 27 22 40
7.Secondary Outcome
Title Number of Participants Sustained Phonophobia-free From 2-24 Hours
Hide Description Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication.
Time Frame 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
Arm/Group Title Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg
Hide Arm/Group Description:
A single matching placebo tablet taken within a 12-week period
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
Overall Number of Participants Analyzed 144 96 96 151
Measure Type: Number
Unit of Measure: participants
Total Population, n=144, 96, 96, 151 47 48 51 79
12-14 years, n=71, 43, 46, 65 27 24 31 36
15-17 years, n=73, 53, 50, 86 20 24 20 43
8.Secondary Outcome
Title Number of Participants Sustained Nausea-free From 2-24 Hours
Hide Description Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication.
Time Frame 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
Arm/Group Title Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg
Hide Arm/Group Description:
A single matching placebo tablet taken within a 12-week period
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
Overall Number of Participants Analyzed 144 95 96 151
Measure Type: Number
Unit of Measure: participants
Total Population, n=144, 95, 96, 151 68 67 64 94
12-14 years, n=71, 43, 46, 65 39 31 33 43
15-17 years, n=73, 52, 50, 86 29 36 31 51
9.Secondary Outcome
Title Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose
Hide Description Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive.
Time Frame 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
Arm/Group Title Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg
Hide Arm/Group Description:
A single matching placebo tablet taken within a 12-week period
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
Overall Number of Participants Analyzed 145 96 97 152
Measure Type: Number
Unit of Measure: participants
Total Population, n=145, 96, 97, 152 47 14 16 21
12-14 years, n=71, 43, 46, 65 21 5 6 10
15-17 years, n=74, 53, 51, 87 26 9 10 11
10.Secondary Outcome
Title Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
Hide Description Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued < 2 hours post-treatment.
Time Frame Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
Arm/Group Title Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg
Hide Arm/Group Description:
A single matching placebo tablet taken within a 12-week period
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
Overall Number of Participants Analyzed 145 96 96 152
Measure Type: Number
Unit of Measure: participants
Total Population, 1 hour, n=145, 96, 96, 152 2 0 0 2
Total Population, 2 hours, n=145, 96, 96, 152 10 0 6 3
Total Population, 3 hours, n=145, 96, 96, 152 29 6 11 15
Total Population, 4 hours, n=145, 96, 96, 152 34 6 13 16
Total Population, 8 hours, n=145, 96, 96, 152 45 9 15 20
Total Population, 12 hours, n=145, 96, 96, 152 48 11 15 20
Total Population, 18 hours, n=145, 96, 96, 152 50 13 15 22
Total Population, 24 hours, n=145, 96, 96, 152 52 14 17 23
12-14 years, 1 hour, n=71, 43, 46, 65 1 0 0 0
12-14 years, 2 hours, n=71, 43, 46, 65 4 0 1 1
12-14 years, 3 hours, n=71, 43, 46, 65 11 1 2 7
12-14 years, 4 hours, n=71, 43, 46, 65 14 1 4 8
12-14 years, 8 hours, n=71, 43, 46, 65 20 4 4 10
12-14 years, 12 hours, n=71, 43, 46, 65 10 4 4 10
12-14 years, 18 hours, n=71, 43, 46, 65 21 4 4 10
12-14 years, 24 hours, n=71, 43, 46, 65 22 5 6 10
15-17 years, 1 hour, n=74, 53, 50, 87 1 0 0 2
15-17 years, 2 hours, n=74, 53, 50, 87 6 0 5 2
15-17 years, 3 hours, n=74, 53, 50, 87 18 5 9 8
15-17 years, 4 hours, n=74, 53, 50, 87 20 5 9 8
15-17 years, 8 hours, n=74, 53, 50, 87 25 5 11 10
15-17 years, 12 hours, n=74, 53, 50, 87 28 7 11 10
15-17 years, 18 hours, n=74, 53, 50, 87 29 9 11 12
15-17 years, 24 hours, n=74, 53, 50, 87 30 9 11 13
11.Secondary Outcome
Title Number of Participants Nausea-free at 2 Hours Post-dose
Hide Description The number of participants who did not have nausea at 2 hours post dose was analzyed.
Time Frame 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
Arm/Group Title Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg
Hide Arm/Group Description:
A single matching placebo tablet taken within a 12-week period
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
Overall Number of Participants Analyzed 144 95 96 151
Measure Type: Number
Unit of Measure: participants
Total Population, n=144, 95, 96, 151 101 78 74 106
12-14 years, n=71, 43, 46, 65 55 36 38 47
15-17 years, n=73, 52, 50, 86 46 42 36 59
12.Other Pre-specified Outcome
Title Mean Age of Participants at Baseline Categorized by Age Group
Hide Description The mean age of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 12 to 14 Years Age Group 15 to 17 Years Age Group
Hide Arm/Group Description:
Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
Overall Number of Participants Analyzed 225 265
Mean (Standard Deviation)
Unit of Measure: Years
13.1  (0.79) 16.1  (0.84)
13.Other Pre-specified Outcome
Title Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline
Hide Description The number of participants receiving double-blind treatment were reported according to age.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg
Hide Arm/Group Description:
A single matching placebo tablet taken within a 12-week period
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
Overall Number of Participants Analyzed 145 96 97 152
Measure Type: Number
Unit of Measure: Participants
12-14 years 71 43 46 65
15-17 years 74 53 51 87
14.Other Pre-specified Outcome
Title Number of Female and Male Participants Categorized by Age Group
Hide Description The gender of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 12 to 14 Years Age Group 15 to 17 Years Age Group
Hide Arm/Group Description:
Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
Overall Number of Participants Analyzed 225 265
Measure Type: Number
Unit of Measure: Participants
Female 114 173
Male 111 92
15.Other Pre-specified Outcome
Title Number of Participants of the Indicated Race Categorized by Age Group
Hide Description The race of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 12 to 14 Years Age Group 15 to 17 Years Age Group
Hide Arm/Group Description:
Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
Overall Number of Participants Analyzed 225 265
Measure Type: Number
Unit of Measure: Participants
African American/African Heritage 31 32
American Indian or Alaska Native 1 0
Asian 2 2
Native Hawaiian or other Pacific Islander 1 0
White 181 216
African American/African Heritage and White 2 4
American Indian or Alaska Native and White 4 4
Asian and Native Hawaiian/other Pacific Islander 0 1
Asian and White 2 3
Native Hawaiian/ other Pacific Islander and White 0 2
Missing 1 1
16.Other Pre-specified Outcome
Title Mean Weight of Participants at Baseline Categorized by Age Group
Hide Description The mean weight of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 12 to 14 Years Age Group 15 to 17 Years Age Group
Hide Arm/Group Description:
Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
Overall Number of Participants Analyzed 225 265
Mean (Standard Deviation)
Unit of Measure: Kilograms (kg)
58.7  (15.55) 69.6  (17.78)
17.Other Pre-specified Outcome
Title Mean Body Mass Index of Participants at Baseline Categorized by Age Group
Hide Description The mean body mass index of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. Body mass index is calculated as: weight (kilograms [kg]) divided by height (meters [m]^2).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 12 to 14 Years Age Group 15 to 17 Years Age Group
Hide Arm/Group Description:
Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
Overall Number of Participants Analyzed 225 265
Mean (Standard Deviation)
Unit of Measure: Kilograms per meters squared (kg/m^2)
22.6  (5.06) 24.6  (5.44)
Time Frame Serious adverse events (SAEs) and AEs were collected from the start of investigational product (IP) in the Run-In Phase until follow-up (up through 1 week after single dose of double-blind IP for participants who took double-blind IP, up to Week 26).
Adverse Event Reporting Description Treatment-emergent SAEs/AEs occurring in the Double-blind Treatment Phase are shown for Arms 1-4. Single-blind placebo-emergent SAEs/AEs occurring in the Run-In Phase are shown for Arm 5.
 
Arm/Group Title Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg Single-blind Run-In Phase Placebo
Hide Arm/Group Description A single matching double-blind placebo tablet taken within a 12-week period A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period One tablet of single-blind placebo taken during the Run-In Phase
All-Cause Mortality
Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg Single-blind Run-In Phase Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg Single-blind Run-In Phase Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/145 (0.00%)   0/96 (0.00%)   0/97 (0.00%)   0/152 (0.00%)   2/683 (0.29%) 
Injury, poisoning and procedural complications           
Clavicle fracture  1  0/145 (0.00%)  0/96 (0.00%)  0/97 (0.00%)  0/152 (0.00%)  1/683 (0.15%) 
Concussion  1  0/145 (0.00%)  0/96 (0.00%)  0/97 (0.00%)  0/152 (0.00%)  1/683 (0.15%) 
Jaw fracture  1  0/145 (0.00%)  0/96 (0.00%)  0/97 (0.00%)  0/152 (0.00%)  1/683 (0.15%) 
Reproductive system and breast disorders           
Testicular torsion  1  0/145 (0.00%)  0/96 (0.00%)  0/97 (0.00%)  0/152 (0.00%)  1/683 (0.15%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.5%
Placebo Sumatriptan 10 mg/ Naproxen 60 mg Sumatriptan 30 mg/ Naproxen 180 mg Sumatriptan 85 mg/ Naproxen 500 mg Single-blind Run-In Phase Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/145 (2.07%)   0/96 (0.00%)   3/97 (3.09%)   4/152 (2.63%)   11/683 (1.61%) 
Infections and infestations           
Nasopharyngitis  1  3/145 (2.07%)  0/96 (0.00%)  1/97 (1.03%)  1/152 (0.66%)  10/683 (1.46%) 
Musculoskeletal and connective tissue disorders           
Muscle tightness  1  0/145 (0.00%)  0/96 (0.00%)  0/97 (0.00%)  3/152 (1.97%)  0/683 (0.00%) 
Vascular disorders           
Hot flush  1  0/145 (0.00%)  0/96 (0.00%)  2/97 (2.06%)  1/152 (0.66%)  1/683 (0.15%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00843024     History of Changes
Other Study ID Numbers: 107979
First Submitted: February 12, 2009
First Posted: February 13, 2009
Results First Submitted: January 22, 2011
Results First Posted: May 9, 2011
Last Update Posted: January 18, 2017