Trial Outcomes & Findings for Migraine Study in Adolescent Patients (NCT NCT00843024)
NCT ID: NCT00843024
Last Updated: 2017-01-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
589 participants
Primary outcome timeframe
2 hours after single dose of double-blind treatment (Randomization through Week 13)
Results posted on
2017-01-18
Participant Flow
Participant milestones
| Measure |
12 to 14 Years Age Group: Single-blind Phase
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.
|
15 to 17 Years Age Group: Single-blind Phase
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.
|
Placebo
After completing the single-blind phase, participants received a single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
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
|
Sumatriptan 30 mg/ Naproxen 180 mg
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
|
Sumatriptan 85 mg/ Naproxen 500 mg
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
|
|---|---|---|---|---|---|---|
|
Single-blind Placebo Run-In Phase
STARTED
|
408
|
457
|
0
|
0
|
0
|
0
|
|
Single-blind Placebo Run-In Phase
COMPLETED
|
268
|
321
|
0
|
0
|
0
|
0
|
|
Single-blind Placebo Run-In Phase
NOT COMPLETED
|
140
|
136
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Phase
STARTED
|
0
|
0
|
176
|
119
|
117
|
177
|
|
Double-blind Treatment Phase
COMPLETED
|
0
|
0
|
145
|
96
|
97
|
152
|
|
Double-blind Treatment Phase
NOT COMPLETED
|
0
|
0
|
31
|
23
|
20
|
25
|
Reasons for withdrawal
| Measure |
12 to 14 Years Age Group: Single-blind Phase
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.
|
15 to 17 Years Age Group: Single-blind Phase
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.
|
Placebo
After completing the single-blind phase, participants received a single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
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
|
Sumatriptan 30 mg/ Naproxen 180 mg
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
|
Sumatriptan 85 mg/ Naproxen 500 mg
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
|
|---|---|---|---|---|---|---|
|
Single-blind Placebo Run-In Phase
Did not meet continuation criteria
|
79
|
74
|
0
|
0
|
0
|
0
|
|
Single-blind Placebo Run-In Phase
Lost to Follow-up
|
36
|
31
|
0
|
0
|
0
|
0
|
|
Single-blind Placebo Run-In Phase
Withdrawal by Subject
|
19
|
18
|
0
|
0
|
0
|
0
|
|
Single-blind Placebo Run-In Phase
Protocol Violation
|
4
|
5
|
0
|
0
|
0
|
0
|
|
Single-blind Placebo Run-In Phase
Physician Decision
|
2
|
6
|
0
|
0
|
0
|
0
|
|
Single-blind Placebo Run-In Phase
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Single-blind Placebo Run-In Phase
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Phase
No opportunity to treat migraine
|
0
|
0
|
20
|
10
|
13
|
14
|
|
Double-blind Treatment Phase
Lost to Follow-up
|
0
|
0
|
8
|
4
|
4
|
4
|
|
Double-blind Treatment Phase
Withdrawal by Subject
|
0
|
0
|
0
|
6
|
0
|
2
|
|
Double-blind Treatment Phase
Protocol Violation
|
0
|
0
|
3
|
0
|
0
|
3
|
|
Double-blind Treatment Phase
Physician Decision
|
0
|
0
|
0
|
3
|
1
|
1
|
|
Double-blind Treatment Phase
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Double-blind Treatment Phase
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Migraine Study in Adolescent Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=145 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=96 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=97 Participants
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=152 Participants
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
Total
n=490 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
14.7 Years
STANDARD_DEVIATION 1.76 • n=5 Participants
|
14.8 Years
STANDARD_DEVIATION 1.81 • n=7 Participants
|
14.7 Years
STANDARD_DEVIATION 1.65 • n=5 Participants
|
14.8 Years
STANDARD_DEVIATION 1.69 • n=4 Participants
|
14.7 Years
STANDARD_DEVIATION 1.72 • n=21 Participants
|
|
Gender
Female
|
85 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
287 Participants
n=21 Participants
|
|
Gender
Male
|
60 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
203 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
25 participants
n=5 Participants
|
17 participants
n=7 Participants
|
9 participants
n=5 Participants
|
12 participants
n=4 Participants
|
63 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
108 participants
n=5 Participants
|
75 participants
n=7 Participants
|
84 participants
n=5 Participants
|
130 participants
n=4 Participants
|
397 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage and White
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native and White
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
8 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian and Native Hawaiian/other Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian and White
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/ other Pacific Islander and White
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Weight
|
63.8 Kilograms (kg)
STANDARD_DEVIATION 16.67 • n=5 Participants
|
64.2 Kilograms (kg)
STANDARD_DEVIATION 19.29 • n=7 Participants
|
62.8 Kilograms (kg)
STANDARD_DEVIATION 14.49 • n=5 Participants
|
66.8 Kilograms (kg)
STANDARD_DEVIATION 19.13 • n=4 Participants
|
64.6 Kilograms (kg)
STANDARD_DEVIATION 17.63 • n=21 Participants
|
|
Body Mass Index
|
23.5 Kilograms per meters squared (kg/m^2)
STANDARD_DEVIATION 5.28 • n=5 Participants
|
23.3 Kilograms per meters squared (kg/m^2)
STANDARD_DEVIATION 5.62 • n=7 Participants
|
22.9 Kilograms per meters squared (kg/m^2)
STANDARD_DEVIATION 4.53 • n=5 Participants
|
24.6 Kilograms per meters squared (kg/m^2)
STANDARD_DEVIATION 5.68 • n=4 Participants
|
23.7 Kilograms per meters squared (kg/m^2)
STANDARD_DEVIATION 5.36 • n=21 Participants
|
PRIMARY outcome
Timeframe: 2 hours after single dose of double-blind treatment (Randomization through Week 13)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=142 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=96 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=97 Participants
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=150 Participants
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Number of Participants Who Were Pain Free at 2 Hours Post-dose
Total Population, n=142, 96, 97, 150
|
14 participants
|
28 participants
|
26 participants
|
36 participants
|
|
Number of Participants Who Were Pain Free at 2 Hours Post-dose
12-14 years, n=70, 43, 46, 65
|
10 participants
|
18 participants
|
13 participants
|
17 participants
|
|
Number of Participants Who Were Pain Free at 2 Hours Post-dose
15-17 years, n=72, 53, 51, 85
|
4 participants
|
10 participants
|
13 participants
|
19 participants
|
SECONDARY outcome
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=142 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=96 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=97 Participants
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=150 Participants
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Number of Participants Sustained Pain-free From 2-24 Hours
15-17 years, n=72, 53, 51, 85
|
3 participants
|
9 participants
|
12 participants
|
18 participants
|
|
Number of Participants Sustained Pain-free From 2-24 Hours
Total Population, n=142, 96, 97, 150
|
13 participants
|
23 participants
|
24 participants
|
35 participants
|
|
Number of Participants Sustained Pain-free From 2-24 Hours
12-14 years, n=70, 43, 46, 65
|
10 participants
|
14 participants
|
12 participants
|
17 participants
|
SECONDARY outcome
Timeframe: 2 hours after single dose of double-blind treatment (Randomization through Week 13)Population: 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.
The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed.
Outcome measures
| Measure |
Placebo
n=144 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=96 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=96 Participants
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=151 Participants
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Number of Participants Photophobia-free at 2 Hours Post-dose
Total Population, n=144, 96, 96, 151
|
59 participants
|
57 participants
|
47 participants
|
89 participants
|
|
Number of Participants Photophobia-free at 2 Hours Post-dose
12-14 years, n=71, 43, 46, 65
|
33 participants
|
29 participants
|
24 participants
|
41 participants
|
|
Number of Participants Photophobia-free at 2 Hours Post-dose
15-17 years, n=73, 53, 50, 86
|
26 participants
|
28 participants
|
23 participants
|
48 participants
|
SECONDARY outcome
Timeframe: 2 hours after single dose of double-blind treatment (Randomization through Week 13)Population: 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.
The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed.
Outcome measures
| Measure |
Placebo
n=144 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=96 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=96 Participants
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=151 Participants
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Number of Participants Phonophobia-free at 2 Hours Post-dose
Total Population, n=144, 96, 96, 151
|
60 participants
|
59 participants
|
55 participants
|
90 participants
|
|
Number of Participants Phonophobia-free at 2 Hours Post-dose
12-14 years, n=71, 43, 46, 65
|
34 participants
|
32 participants
|
33 participants
|
41 participants
|
|
Number of Participants Phonophobia-free at 2 Hours Post-dose
15-17 years, n=73, 53, 50, 86
|
26 participants
|
47 participants
|
22 participants
|
49 participants
|
SECONDARY outcome
Timeframe: 1 hour after single dose of double-blind treatment (Randomization through Week 13)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=142 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=96 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=97 Participants
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=150 Participants
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Number of Participants Pain-free at 1 Hour Post-dose
Total Population, n=142, 96, 97, 150
|
6 participants
|
9 participants
|
6 participants
|
11 participants
|
|
Number of Participants Pain-free at 1 Hour Post-dose
12-14 years, n=70, 43, 46, 65
|
4 participants
|
7 participants
|
2 participants
|
4 participants
|
|
Number of Participants Pain-free at 1 Hour Post-dose
15-17 years, n=72, 53, 51, 85
|
2 participants
|
2 participants
|
4 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=144 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=96 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=96 Participants
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=151 Participants
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Number of Participants Sustained Photophobia-free From 2-24 Hours
Total Population, n=144, 96, 96, 151
|
44 participants
|
48 participants
|
43 participants
|
75 participants
|
|
Number of Participants Sustained Photophobia-free From 2-24 Hours
12-14 years, n=71, 43, 46, 65
|
25 participants
|
21 participants
|
21 participants
|
35 participants
|
|
Number of Participants Sustained Photophobia-free From 2-24 Hours
15-17 years, n=73, 53, 50, 86
|
19 participants
|
27 participants
|
22 participants
|
40 participants
|
SECONDARY outcome
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=144 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=96 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=96 Participants
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=151 Participants
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Number of Participants Sustained Phonophobia-free From 2-24 Hours
Total Population, n=144, 96, 96, 151
|
47 participants
|
48 participants
|
51 participants
|
79 participants
|
|
Number of Participants Sustained Phonophobia-free From 2-24 Hours
12-14 years, n=71, 43, 46, 65
|
27 participants
|
24 participants
|
31 participants
|
36 participants
|
|
Number of Participants Sustained Phonophobia-free From 2-24 Hours
15-17 years, n=73, 53, 50, 86
|
20 participants
|
24 participants
|
20 participants
|
43 participants
|
SECONDARY outcome
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=144 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=95 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=96 Participants
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=151 Participants
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Number of Participants Sustained Nausea-free From 2-24 Hours
15-17 years, n=73, 52, 50, 86
|
29 participants
|
36 participants
|
31 participants
|
51 participants
|
|
Number of Participants Sustained Nausea-free From 2-24 Hours
Total Population, n=144, 95, 96, 151
|
68 participants
|
67 participants
|
64 participants
|
94 participants
|
|
Number of Participants Sustained Nausea-free From 2-24 Hours
12-14 years, n=71, 43, 46, 65
|
39 participants
|
31 participants
|
33 participants
|
43 participants
|
SECONDARY outcome
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=145 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=96 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=97 Participants
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=152 Participants
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose
Total Population, n=145, 96, 97, 152
|
47 participants
|
14 participants
|
16 participants
|
21 participants
|
|
Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose
12-14 years, n=71, 43, 46, 65
|
21 participants
|
5 participants
|
6 participants
|
10 participants
|
|
Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose
15-17 years, n=74, 53, 51, 87
|
26 participants
|
9 participants
|
10 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=145 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=96 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=96 Participants
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=152 Participants
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
Total Population, 3 hours, n=145, 96, 96, 152
|
29 participants
|
6 participants
|
11 participants
|
15 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
Total Population, 4 hours, n=145, 96, 96, 152
|
34 participants
|
6 participants
|
13 participants
|
16 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
12-14 years, 4 hours, n=71, 43, 46, 65
|
14 participants
|
1 participants
|
4 participants
|
8 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
Total Population, 8 hours, n=145, 96, 96, 152
|
45 participants
|
9 participants
|
15 participants
|
20 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
Total Population, 12 hours, n=145, 96, 96, 152
|
48 participants
|
11 participants
|
15 participants
|
20 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
Total Population, 2 hours, n=145, 96, 96, 152
|
10 participants
|
0 participants
|
6 participants
|
3 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
Total Population, 1 hour, n=145, 96, 96, 152
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
15-17 years, 18 hours, n=74, 53, 50, 87
|
29 participants
|
9 participants
|
11 participants
|
12 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
12-14 years, 24 hours, n=71, 43, 46, 65
|
22 participants
|
5 participants
|
6 participants
|
10 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
15-17 years, 1 hour, n=74, 53, 50, 87
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
15-17 years, 2 hours, n=74, 53, 50, 87
|
6 participants
|
0 participants
|
5 participants
|
2 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
15-17 years, 3 hours, n=74, 53, 50, 87
|
18 participants
|
5 participants
|
9 participants
|
8 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
15-17 years, 4 hours, n=74, 53, 50, 87
|
20 participants
|
5 participants
|
9 participants
|
8 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
15-17 years, 8 hours, n=74, 53, 50, 87
|
25 participants
|
5 participants
|
11 participants
|
10 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
15-17 years, 24 hours, n=74, 53, 50, 87
|
30 participants
|
9 participants
|
11 participants
|
13 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
15-17 years, 12 hours, n=74, 53, 50, 87
|
28 participants
|
7 participants
|
11 participants
|
10 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
Total Population, 18 hours, n=145, 96, 96, 152
|
50 participants
|
13 participants
|
15 participants
|
22 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
Total Population, 24 hours, n=145, 96, 96, 152
|
52 participants
|
14 participants
|
17 participants
|
23 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
12-14 years, 1 hour, n=71, 43, 46, 65
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
12-14 years, 2 hours, n=71, 43, 46, 65
|
4 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
12-14 years, 3 hours, n=71, 43, 46, 65
|
11 participants
|
1 participants
|
2 participants
|
7 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
12-14 years, 8 hours, n=71, 43, 46, 65
|
20 participants
|
4 participants
|
4 participants
|
10 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
12-14 years, 12 hours, n=71, 43, 46, 65
|
10 participants
|
4 participants
|
4 participants
|
10 participants
|
|
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
12-14 years, 18 hours, n=71, 43, 46, 65
|
21 participants
|
4 participants
|
4 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 2 hours after single dose of double-blind treatment (Randomization through Week 13)Population: 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.
The number of participants who did not have nausea at 2 hours post dose was analzyed.
Outcome measures
| Measure |
Placebo
n=144 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=95 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=96 Participants
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=151 Participants
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Number of Participants Nausea-free at 2 Hours Post-dose
15-17 years, n=73, 52, 50, 86
|
46 participants
|
42 participants
|
36 participants
|
59 participants
|
|
Number of Participants Nausea-free at 2 Hours Post-dose
Total Population, n=144, 95, 96, 151
|
101 participants
|
78 participants
|
74 participants
|
106 participants
|
|
Number of Participants Nausea-free at 2 Hours Post-dose
12-14 years, n=71, 43, 46, 65
|
55 participants
|
36 participants
|
38 participants
|
47 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=225 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=265 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Mean Age of Participants at Baseline Categorized by Age Group
|
13.1 Years
Standard Deviation 0.79
|
16.1 Years
Standard Deviation 0.84
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT Population
The number of participants receiving double-blind treatment were reported according to age.
Outcome measures
| Measure |
Placebo
n=145 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=96 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=97 Participants
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=152 Participants
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline
12-14 years
|
71 Participants
|
43 Participants
|
46 Participants
|
65 Participants
|
|
Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline
15-17 years
|
74 Participants
|
53 Participants
|
51 Participants
|
87 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT Population
The gender of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.
Outcome measures
| Measure |
Placebo
n=225 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=265 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Number of Female and Male Participants Categorized by Age Group
Female
|
114 Participants
|
173 Participants
|
—
|
—
|
|
Number of Female and Male Participants Categorized by Age Group
Male
|
111 Participants
|
92 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT Population
The race of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.
Outcome measures
| Measure |
Placebo
n=225 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=265 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Number of Participants of the Indicated Race Categorized by Age Group
African American/African Heritage
|
31 Participants
|
32 Participants
|
—
|
—
|
|
Number of Participants of the Indicated Race Categorized by Age Group
American Indian or Alaska Native
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants of the Indicated Race Categorized by Age Group
Asian
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants of the Indicated Race Categorized by Age Group
Native Hawaiian or other Pacific Islander
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants of the Indicated Race Categorized by Age Group
White
|
181 Participants
|
216 Participants
|
—
|
—
|
|
Number of Participants of the Indicated Race Categorized by Age Group
African American/African Heritage and White
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants of the Indicated Race Categorized by Age Group
American Indian or Alaska Native and White
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants of the Indicated Race Categorized by Age Group
Asian and Native Hawaiian/other Pacific Islander
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants of the Indicated Race Categorized by Age Group
Asian and White
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants of the Indicated Race Categorized by Age Group
Native Hawaiian/ other Pacific Islander and White
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants of the Indicated Race Categorized by Age Group
Missing
|
1 Participants
|
1 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=225 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=265 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Mean Weight of Participants at Baseline Categorized by Age Group
|
58.7 Kilograms (kg)
Standard Deviation 15.55
|
69.6 Kilograms (kg)
Standard Deviation 17.78
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT Population
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).
Outcome measures
| Measure |
Placebo
n=225 Participants
A single matching placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=265 Participants
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
|---|---|---|---|---|
|
Mean Body Mass Index of Participants at Baseline Categorized by Age Group
|
22.6 Kilograms per meters squared (kg/m^2)
Standard Deviation 5.06
|
24.6 Kilograms per meters squared (kg/m^2)
Standard Deviation 5.44
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sumatriptan 10 mg/ Naproxen 60 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sumatriptan 30 mg/ Naproxen 180 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sumatriptan 85 mg/ Naproxen 500 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Single-blind Run-In Phase Placebo
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=145 participants at risk
A single matching double-blind placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=96 participants at risk
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=97 participants at risk
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=152 participants at risk
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
Single-blind Run-In Phase Placebo
n=683 participants at risk
One tablet of single-blind placebo taken during the Run-In Phase
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/145 • 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).
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.
|
0.00%
0/96 • 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).
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.
|
0.00%
0/97 • 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).
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.
|
0.00%
0/152 • 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).
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.
|
0.15%
1/683 • 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).
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.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/145 • 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).
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.
|
0.00%
0/96 • 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).
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.
|
0.00%
0/97 • 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).
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.
|
0.00%
0/152 • 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).
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.
|
0.15%
1/683 • 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).
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.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/145 • 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).
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.
|
0.00%
0/96 • 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).
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.
|
0.00%
0/97 • 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).
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.
|
0.00%
0/152 • 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).
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.
|
0.15%
1/683 • 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).
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.
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.00%
0/145 • 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).
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.
|
0.00%
0/96 • 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).
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.
|
0.00%
0/97 • 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).
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.
|
0.00%
0/152 • 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).
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.
|
0.15%
1/683 • 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).
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.
|
Other adverse events
| Measure |
Placebo
n=145 participants at risk
A single matching double-blind placebo tablet taken within a 12-week period
|
Sumatriptan 10 mg/ Naproxen 60 mg
n=96 participants at risk
A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
|
Sumatriptan 30 mg/ Naproxen 180 mg
n=97 participants at risk
A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
|
Sumatriptan 85 mg/ Naproxen 500 mg
n=152 participants at risk
A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
|
Single-blind Run-In Phase Placebo
n=683 participants at risk
One tablet of single-blind placebo taken during the Run-In Phase
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.1%
3/145 • 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).
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.
|
0.00%
0/96 • 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).
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.
|
1.0%
1/97 • 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).
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.
|
0.66%
1/152 • 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).
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.
|
1.5%
10/683 • 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).
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.
|
|
Vascular disorders
Hot flush
|
0.00%
0/145 • 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).
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.
|
0.00%
0/96 • 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).
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.
|
2.1%
2/97 • 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).
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.
|
0.66%
1/152 • 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).
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.
|
0.15%
1/683 • 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).
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/145 • 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).
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.
|
0.00%
0/96 • 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).
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.
|
0.00%
0/97 • 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).
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.
|
2.0%
3/152 • 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).
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.
|
0.00%
0/683 • 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).
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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER