| Primary | Number of Participants Who Were Pain Free at 2 Hours Post-dose | 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. | 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. | Posted | | Number | | participants | | 2 hours after single dose of double-blind treatment (Randomization through Week 13) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A single matching placebo tablet taken within a 12-week period | | OG001 | Sumatriptan 10 mg/ Naproxen 60 mg | A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period | | OG002 | 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 | | OG003 | 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 |
| | Units | Counts |
|---|
| Participants | - OG000142
- OG00196
- OG00297
- OG003
|
| | Title | Denominators | Categories |
|---|
| Total Population, n=142, 96, 97, 150 | | | Title | Measurements |
|---|
| - OG00014
- OG00128
- OG00226
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Cochran-Mantel-Haenszel | | 0.003 | Adjusted for multiplicity according to the fixed sequence testing strategy | Mean Difference (Final Values) | 0.20 | | | 2-Sided | 95 | 0.09 | 0.30 | | | Sumatriptan 10 mg/Naproxen 60 mg minus placebo | No | Superiority or Other | | | | |
|
| Secondary | Number of Participants Sustained Pain-free From 2-24 Hours | 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. | 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. | Posted | | Number | | participants | | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A single matching placebo tablet taken within a 12-week period | | OG001 | Sumatriptan 10 mg/ Naproxen 60 mg | A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period | | OG002 | 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 | | OG003 |
|
| Secondary | Number of Participants Photophobia-free at 2 Hours Post-dose | The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed. | 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. | Posted | | Number | | participants | | 2 hours after single dose of double-blind treatment (Randomization through Week 13) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A single matching placebo tablet taken within a 12-week period | | OG001 | Sumatriptan 10 mg/ Naproxen 60 mg | A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period | | OG002 | 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 | | OG003 | Sumatriptan 85 mg/ Naproxen 500 mg |
|
| Secondary | Number of Participants Phonophobia-free at 2 Hours Post-dose | The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed. | 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. | Posted | | Number | | participants | | 2 hours after single dose of double-blind treatment (Randomization through Week 13) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A single matching placebo tablet taken within a 12-week period | | OG001 | Sumatriptan 10 mg/ Naproxen 60 mg | A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period | | OG002 | 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 | | OG003 | Sumatriptan 85 mg/ Naproxen 500 mg |
|
| Secondary | Number of Participants Pain-free at 1 Hour Post-dose | 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. | 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. | Posted | | Number | | participants | | 1 hour after single dose of double-blind treatment (Randomization through Week 13) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A single matching placebo tablet taken within a 12-week period | | OG001 | Sumatriptan 10 mg/ Naproxen 60 mg | A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period | | OG002 | 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 |
|
| Secondary | Number of Participants Sustained Photophobia-free From 2-24 Hours | 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. | 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. | Posted | | Number | | participants | | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A single matching placebo tablet taken within a 12-week period | | OG001 | Sumatriptan 10 mg/ Naproxen 60 mg | A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period | | OG002 | 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 | | OG003 |
|
| Secondary | Number of Participants Sustained Phonophobia-free From 2-24 Hours | 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. | 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. | Posted | | Number | | participants | | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A single matching placebo tablet taken within a 12-week period | | OG001 | Sumatriptan 10 mg/ Naproxen 60 mg | A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period | | OG002 | 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 | | OG003 |
|
| Secondary | Number of Participants Sustained Nausea-free From 2-24 Hours | 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. | 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. | Posted | | Number | | participants | | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A single matching placebo tablet taken within a 12-week period | | OG001 | Sumatriptan 10 mg/ Naproxen 60 mg | A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period | | OG002 | 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 | | OG003 | Sumatriptan 85 mg/ Naproxen 500 mg |
|
| Secondary | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | 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. | 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. | Posted | | Number | | participants | | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A single matching placebo tablet taken within a 12-week period | | OG001 | Sumatriptan 10 mg/ Naproxen 60 mg | A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period | | OG002 | Sumatriptan 30 mg/ Naproxen 180 mg | |
|
| Secondary | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 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. | 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. | Posted | | Number | | participants | | Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A single matching placebo tablet taken within a 12-week period | | OG001 | Sumatriptan 10 mg/ Naproxen 60 mg | A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period | | OG002 | 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 |
|
| Secondary | Number of Participants Nausea-free at 2 Hours Post-dose | The number of participants who did not have nausea at 2 hours post dose was analzyed. | 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. | Posted | | Number | | participants | | 2 hours after single dose of double-blind treatment (Randomization through Week 13) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A single matching placebo tablet taken within a 12-week period | | OG001 | Sumatriptan 10 mg/ Naproxen 60 mg | A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period | | OG002 | 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 | | OG003 | Sumatriptan 85 mg/ Naproxen 500 mg | |
|
| Other Pre-specified | Mean Age of Participants at Baseline Categorized by Age Group | 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. | | Posted | | Mean | Standard Deviation | Years | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | 12 to 14 Years Age Group | 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 | | OG001 | 15 to 17 Years Age Group | 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 |
| |
| Other Pre-specified | Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline | The number of participants receiving double-blind treatment were reported according to age. | | Posted | | Number | | Participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | A single matching placebo tablet taken within a 12-week period | | OG001 | Sumatriptan 10 mg/ Naproxen 60 mg | A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period | | OG002 | 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 | | OG003 | 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 |
| |
| Other Pre-specified | Number of Female and Male Participants Categorized by Age Group | The gender of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups. | | Posted | | Number | | Participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | 12 to 14 Years Age Group | 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 | | OG001 | 15 to 17 Years Age Group | 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 |
| |
| Other Pre-specified | Number of Participants of the Indicated Race Categorized by Age Group | The race of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups. | | Posted | | Number | | Participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | 12 to 14 Years Age Group | 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 | | OG001 | 15 to 17 Years Age Group | 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 |
| |
| Other Pre-specified | Mean Weight of Participants at Baseline Categorized by Age Group | 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. | | Posted | | Mean | Standard Deviation | Kilograms (kg) | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | 12 to 14 Years Age Group | 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 | | OG001 | 15 to 17 Years Age Group | 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 |
| |
| Other Pre-specified | Mean Body Mass Index of Participants at Baseline Categorized by Age Group | 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). | | Posted | | Mean | Standard Deviation | Kilograms per meters squared (kg/m^2) | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | 12 to 14 Years Age Group | 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 | | OG001 | 15 to 17 Years Age Group | 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 |
| |