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The purpose of this study is to test the effect on blood pressure of sumatriptan and naproxen sodium combination tablets, tablets containing only sumatriptan, and tablets containing only naproxen sodium when these drugs are taken to treat migraine headaches that occur during a 6-month period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sumatriptan and naproxen sodium combination | Experimental |
| |
| sumatriptan | Active Comparator |
| |
| naproxen sodium | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sumatriptan and naproxen sodium combination tablet | Drug | sumatriptan 85mg and naproxen sodium 500mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen | The calculation of baseline and post-baseline mean blood pressure (BP) (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM). | Baseline and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen | The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM). |
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Inclusion Criteria:
Subjects eligible for enrollment in the study must meet all of the following criteria:
Male and female outpatients 18 to 65 years of age. Female subjects are eligible for participation in the study if they are:
Subject with migraines, with or without aura (ICHD-II criteria, 1.2.1 or 1.1) [International Headache Society, 2004]. Subject must have a history of two to eight attacks per month, on average, for the six months prior to the Screening Visit. Additionally the subject is to have experienced at least two, but no more than eight, migraine attacks per month for the three months prior to Screening Visit.
Subject is able to distinguish migraine attacks from other headaches (i.e. tension-type headaches).
Subject is willing and able to provide written informed consent, to comprehend and perform the requirements of the protocol.
Exclusion criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Chandler | Arizona | 85224 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22142350 | Background | White WB, Derosier FJ, Thompson AH, Adams BE, Goodman DK. Evaluation of the migraine treatment sumatriptan/naproxen sodium on blood pressure following long-term administration. J Clin Hypertens (Greenwich). 2011 Dec;13(12):910-6. doi: 10.1111/j.1751-7176.2011.00554.x. Epub 2011 Nov 11. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 110948 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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The number of participants defined as starting the study in the Participant Flow module includes only those participants randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sumatriptan/Naproxen | Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack |
| FG001 | Sumatriptan | Sumatriptan 85 mg tablet taken after migraine attack |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| sumatriptan tablet | Drug | sumatriptan 85mg |
|
| naproxen sodium tablet | Drug | Naproxen sodium 500mg |
|
| Baseline and Month 6 |
| Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan | The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM). | Baseline and Month 6 |
| Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen | The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM). | Baseline and Month 6 |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month | The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis. LSMeans and corresponding confidence intervals were not calculated for > 6 migraines/month group due to lack of convergence. | Baseline and Month 6 |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine | The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis. | Baseline and Month 6 |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month | The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 10-14 and the >14 doses/month groups due to lack of convergence. | Baseline and Month 6 |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses | The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 60-90 and the >90 total dose groups due to lack of convergence. | Baseline and Month 6 |
| Number of Participants With an Increase of >=5 mmHg From the Baseline Systolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements | The number of participants with an increase of >=5 mmHg from the baseline systolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. | Baseline to End of Study (6-month study duration) |
| Number of Participants With an Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements | The number of participants with an increase of >=3 mmHg from the baseline diastolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. | Baseline to End of Study (6-month study duration) |
| Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study | The number of participants with any valid two-day consecutive average systolic blood pressure measurement of >=140 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. | Baseline to End of Study (6-month study duration) |
| Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg | The number of participants with any valid two-day consecutive average diastolic blood pressure measurement of >=90 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. | Baseline to End of Study (6-month study duration) |
| Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure | Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. | Baseline to End of Study (6-month study duration) |
| Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure | Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. | Baseline to End of Study (6-month study duration) |
| Number of Participants Withdrawn From the Study Due to Blood Pressure Changes | The number of participants withdrawn from the study due to protocol-defined blood pressure changes were summarized for each treatment group. Defined blood pressure changes included (1) monthly average BP ≥140 mmHg systolic or >=90 mmHg diastolic and confirmed in clinic, (2) monthly average BP increase of >=30 mmHg systolic or >=20 mmHg from in-clinic screening and confirmed in clinic, and (3) systolic >=140 mmHg or diastolic >=90 mmHg on consecutive clinic visits >=2 weeks apart. | Baseline to End of Study (6-month study duration) |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| GSK Investigational Site | Litchfield Park | Arizona | 85340 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85050 | United States |
| GSK Investigational Site | Tempe | Arizona | 85283 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | Anaheim | California | 92801 | United States |
| GSK Investigational Site | Anaheim | California | 92805 | United States |
| GSK Investigational Site | Buena Park | California | 90620 | United States |
| GSK Investigational Site | Garden Grove | California | 92845 | United States |
| GSK Investigational Site | Newport Beach | California | 92660 | United States |
| GSK Investigational Site | Santa Monica | California | 90404 | United States |
| GSK Investigational Site | Westlake Village | California | 91361 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80904 | United States |
| GSK Investigational Site | Avon | Connecticut | 06001 | United States |
| GSK Investigational Site | Hialeah | Florida | 33010 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32216 | United States |
| GSK Investigational Site | Miami | Florida | 33143 | United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| GSK Investigational Site | St. Petersburg | Florida | 33702 | United States |
| GSK Investigational Site | Sunrise | Florida | 33351 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30308 | United States |
| GSK Investigational Site | Decatur | Georgia | 30034 | United States |
| GSK Investigational Site | Chicago | Illinois | 60614 | United States |
| GSK Investigational Site | Wichita | Kansas | 67207 | United States |
| GSK Investigational Site | Kalamazoo | Michigan | 49009 | United States |
| GSK Investigational Site | Springfield | Missouri | 65807 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Greensboro | North Carolina | 27405 | United States |
| GSK Investigational Site | Harrisburg | North Carolina | 28075 | United States |
| GSK Investigational Site | Matthews | North Carolina | 28105 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27612 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44122 | United States |
| GSK Investigational Site | West Chester | Ohio | 45069 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15236 | United States |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| GSK Investigational Site | Simpsonville | South Carolina | 29681 | United States |
| GSK Investigational Site | Bristol | Tennessee | 37620 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38018 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Houston | Texas | 77004 | United States |
| GSK Investigational Site | San Antonio | Texas | 78205 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84107 | United States |
| GSK Investigational Site | West Jordan | Utah | 84088 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110948 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110948 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110948 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110948 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110948 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110948 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG002 | Naproxen | Naproxen sodium 500 mg tablet taken after migraine attack |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sumatriptan/Naproxen | Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack |
| BG001 | Sumatriptan | Sumatriptan 85 mg tablet taken after migraine attack |
| BG002 | Naproxen | Naproxen sodium 500 mg tablet taken after migraine attack |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment. Not all randomized participants were part of the ITT Population. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment. Not all randomized participants were part of the ITT Population. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment. Not all participants were enrolled in the ITT Population. | Number | participants |
| |||||||||||||||
| Average Number of Migraine Attacks per Month | Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment. The average number of migraines per month for the 6-month period prior to Screening is presented. | Mean | Standard Deviation | migraines |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Secondary | Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen | The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM). | ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections. | Posted | Mean | Standard Deviation | mmHg | Baseline and Month 6 |
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| Primary | Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen | The calculation of baseline and post-baseline mean blood pressure (BP) (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM). | Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home BP assessment. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline and Month 6 |
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| Secondary | Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan | The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM). | ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections. | Posted | Mean | Standard Error | mmHg | Baseline and Month 6 |
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| Secondary | Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen | The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM). | ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections. | Posted | Mean | Standard Deviation | mmHg | Baseline and Month 6 |
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| Secondary | Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month | The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis. LSMeans and corresponding confidence intervals were not calculated for > 6 migraines/month group due to lack of convergence. | Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline and Month 6 |
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| Secondary | Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine | The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis. | Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline and Month 6 |
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| Secondary | Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month | The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 10-14 and the >14 doses/month groups due to lack of convergence. | Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline and Month 6 |
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| Secondary | Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses | The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 60-90 and the >90 total dose groups due to lack of convergence. | Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline and Month 6 |
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| Secondary | Number of Participants With an Increase of >=5 mmHg From the Baseline Systolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements | The number of participants with an increase of >=5 mmHg from the baseline systolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. | ITT Population. Only participants with valid blood pressure measurements were analyzed. | Posted | Number | participants | Baseline to End of Study (6-month study duration) |
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| Secondary | Number of Participants With an Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements | The number of participants with an increase of >=3 mmHg from the baseline diastolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. | ITT Population. Only participants with valid blood pressure measurements were analyzed. | Posted | Number | participants | Baseline to End of Study (6-month study duration) |
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| Secondary | Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study | The number of participants with any valid two-day consecutive average systolic blood pressure measurement of >=140 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. | ITT Population | Posted | Number | participants | Baseline to End of Study (6-month study duration) |
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| Secondary | Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg | The number of participants with any valid two-day consecutive average diastolic blood pressure measurement of >=90 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. | ITT Population | Posted | Number | participants | Baseline to End of Study (6-month study duration) |
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| Secondary | Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure | Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. | ITT Population. Only participants with valid blood pressure measurements were analyzed. | Posted | Median | Full Range | days | Baseline to End of Study (6-month study duration) |
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| Secondary | Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure | Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. | ITT Population. Only participants with valid blood pressure measurements were analyzed. | Posted | Median | Full Range | days | Baseline to End of Study (6-month study duration) |
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| Secondary | Number of Participants Withdrawn From the Study Due to Blood Pressure Changes | The number of participants withdrawn from the study due to protocol-defined blood pressure changes were summarized for each treatment group. Defined blood pressure changes included (1) monthly average BP ≥140 mmHg systolic or >=90 mmHg diastolic and confirmed in clinic, (2) monthly average BP increase of >=30 mmHg systolic or >=20 mmHg from in-clinic screening and confirmed in clinic, and (3) systolic >=140 mmHg or diastolic >=90 mmHg on consecutive clinic visits >=2 weeks apart. | ITT Population | Posted | Number | participants | Baseline to End of Study (6-month study duration) |
|
Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
SAEs and AEs were collected in the Safety Population, which is comprised of all participants who took at least one dose of investigational product. SAE term "abortion induced" was actually coded to surgical and medical procedures in the MedDRA dictionary; however, this organ system is not available in the current template drop-down list.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sumatriptan/Naproxen | Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack | 3 | 127 | 20 | 127 | ||
| EG001 | Sumatriptan | Sumatriptan 85 mg tablet taken after migraine attack | 1 | 120 | 29 | 120 | ||
| EG002 | Naproxen | Naproxen sodium 500 mg tablet taken after migraine attack | 0 | 127 | 18 | 127 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA, v12.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA, v12.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA, v12.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, v12.0 | Systematic Assessment |
| |
| Abortion induced | Pregnancy, puerperium and perinatal conditions | MedDRA, v12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA, v12.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, v12.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA, v12.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, v12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, v12.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA, v12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, v12.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA, v12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, v12.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA, v12.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA, v12.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
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| African American/African Heritage |
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| Asian |
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| Asian and White |
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| American Indian or Alaska Native |
|
| Systolic, Change from Baseline, n=41, 36 |
|
| Diastolic, Baseline, n=109, 115 |
|
| Diastolic, Month 6, n=42, 37 |
|
| Diastolic, Change from Baseline, n=41, 36 |
|
| Least-squares mean |
| -0.9 |
| 2-Sided |
| 95 |
| -2.2 |
| 0.3 |
Diastolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure |
| No |
| Superiority or Other |
| Least-squares mean | -1.9 | 2-Sided | 95 | -3.4 | -0.4 | Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure | No | Superiority or Other |
| Least-squares mean | -0.7 | 2-Sided | 95 | -2.0 | 0.6 | Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure | No | Superiority or Other |
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Naproxen sodium 500 mg tablet taken after migraine attack
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