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A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-month Period

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ClinicalTrials.gov Identifier: NCT00792636
Recruitment Status : Completed
First Posted : November 18, 2008
Results First Posted : November 4, 2010
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Migraine Disorders
Interventions Drug: sumatriptan and naproxen sodium combination tablet
Drug: sumatriptan tablet
Drug: naproxen sodium tablet
Enrollment 407
Recruitment Details  
Pre-assignment Details The number of participants defined as starting the study in the Participant Flow module includes only those participants randomized to treatment.
Arm/Group Title Sumatriptan/Naproxen Sumatriptan Naproxen
Hide Arm/Group Description Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack Sumatriptan 85 mg tablet taken after migraine attack Naproxen sodium 500 mg tablet taken after migraine attack
Period Title: Overall Study
Started 135 136 136
Completed 67 55 55
Not Completed 68 81 81
Reason Not Completed
Protocol Violation             17             23             20
Met Protocol-defined Stopping Criteria             19             20             20
Lost to Follow-up             13             19             14
Withdrew Consent             10             13             9
Lack of Efficacy             3             4             13
Adverse Event             4             2             3
Investigator Discretion             2             0             2
Arm/Group Title Sumatriptan/Naproxen Sumatriptan Naproxen Total
Hide Arm/Group Description Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack Sumatriptan 85 mg tablet taken after migraine attack Naproxen sodium 500 mg tablet taken after migraine attack Total of all reporting groups
Overall Number of Baseline Participants 122 112 118 352
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 122 participants 112 participants 118 participants 352 participants
39.0  (11.64) 39.8  (11.22) 39.1  (11.92) 39.3  (11.58)
[1]
Measure Description: 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.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 112 participants 118 participants 352 participants
Female
94
  77.0%
98
  87.5%
96
  81.4%
288
  81.8%
Male
28
  23.0%
14
  12.5%
22
  18.6%
64
  18.2%
[1]
Measure Description: 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.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 122 participants 112 participants 118 participants 352 participants
White 108 96 105 309
African American/African Heritage 12 11 10 33
Asian 2 3 3 8
Asian and White 0 1 0 1
American Indian or Alaska Native 0 1 0 1
[1]
Measure Description: 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.
Average Number of Migraine Attacks per Month   [1] 
Mean (Standard Deviation)
Unit of measure:  Migraines
Number Analyzed 122 participants 112 participants 118 participants 352 participants
4.5  (1.76) 4.2  (1.67) 4.6  (1.8) 4.4  (1.75)
[1]
Measure Description: 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.
1.Primary Outcome
Title Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen
Hide Description 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).
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sumatriptan/Naproxen
Hide Arm/Group Description:
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: millimeters of mercury (mmHg)
Systolic, Baseline, n=120 111.7  (9.00)
Systolic, Month 6, n=48 107.1  (9.59)
Systolic, Change from Baseline, n=47 -2.9  (5.24)
Diastolic, Baseline, n=120 76.0  (6.83)
Diastolic, Month 6, n=48 73.0  (6.84)
Diastolic, Change from Baseline, n=47 -2.1  (4.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-squares mean
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-3.4 to -0.8
Estimation Comments Systolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-squares mean
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-2.6 to -0.3
Estimation Comments Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure
2.Secondary Outcome
Title Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen
Hide Description 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).
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sumatriptan Naproxen
Hide Arm/Group Description:
Sumatriptan 85 mg tablet taken after migraine attack
Naproxen sodium 500 mg tablet taken after migraine attack
Overall Number of Participants Analyzed 109 115
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic, Baseline, n=109, 115 110.8  (9.15) 110.1  (9.19)
Systolic, Month 6, n=42, 37 109.4  (7.70) 108.2  (9.16)
Systolic, Change from Baseline, n=41, 36 -2.8  (5.69) -1.8  (6.53)
Diastolic, Baseline, n=109, 115 75.7  (7.38) 74.7  (7.00)
Diastolic, Month 6, n=42, 37 73.9  (7.03) 74.3  (8.47)
Diastolic, Change from Baseline, n=41, 36 -1.6  (4.21) -0.6  (5.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sumatriptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-squares mean
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-3.2 to -0.3
Estimation Comments Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sumatriptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-squares mean
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.2 to 0.3
Estimation Comments Diastolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Naproxen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-squares mean
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-3.4 to -0.4
Estimation Comments Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Naproxen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-squares mean
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-2.0 to 0.6
Estimation Comments Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure
3.Secondary Outcome
Title Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan
Hide Description 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).
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sumatriptan/Naproxen Sumatriptan
Hide Arm/Group Description:
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Sumatriptan 85 mg tablet taken after migraine attack
Overall Number of Participants Analyzed 120 109
Mean (Standard Error)
Unit of Measure: mmHg
Systolic, Baseline, n=120, 109 111.7  (9.00) 110.8  (9.15)
Systolic, Month 6, n=48, 42 107.1  (9.59) 109.4  (7.70)
Systolic, Change from Baseline, n=47, 41 -2.9  (5.24) -2.8  (5.69)
Diastolic, Baseline, n=120, 109 76.0  (6.83) 75.7  (7.38)
Diastolic, Month 6, n=48, 42 73.0  (6.84) 73.9  (7.03)
Diastolic, Change from Baseline, n=47, 41 -2.1  (4.44) -1.6  (4.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Sumatriptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-squares mean
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.6 to 2.4
Estimation Comments Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Sumatriptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-squares mean
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-1.2 to 2.2
Estimation Comments Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure
4.Secondary Outcome
Title Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen
Hide Description 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).
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sumatriptan/Naproxen Naproxen
Hide Arm/Group Description:
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Naproxen sodium 500 mg tablet taken after migraine attack
Overall Number of Participants Analyzed 120 115
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic, Baseline, n=120, 115 111.7  (9.00) 110.1  (9.19)
Systolic, Month 6, n=48, 37 107.1  (9.59) 108.2  (9.16)
Systolic, Change from Baseline, n=47, 36 -2.9  (5.24) -1.8  (6.53)
Diastolic, Baseline, n=120, 115 76.0  (6.83) 74.7  (7.00)
Diastolic, Month 6, n=48, 37 73.0  (6.84) 74.3  (8.47)
Diastolic, Change from Baseline, n=47, 36 -2.1  (4.44) -0.6  (5.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Naproxen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-squares mean
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.7 to 2.2
Estimation Comments Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Naproxen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-squares mean
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-0.9 to 2.5
Estimation Comments Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure
5.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sumatriptan/Naproxen
Hide Arm/Group Description:
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Overall Number of Participants Analyzed 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
Systolic, <4 migraines per month
-2.0
(-3.5 to -0.5)
Systolic, 4-6 migraines per month
-3.3
(-7.0 to 0.4)
Systolic, >=4 migraines per month
-3.7
(-6.7 to -0.7)
Diastolic, <4 migraines per month
-1.2
(-2.5 to 0.00)
Diastolic, 4-6 migraines per month
-5.3
(-9.9 to -0.6)
Diastolic, >=4 migraines per month
-4.1
(-7.2 to -1.1)
6.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sumatriptan/Naproxen
Hide Arm/Group Description:
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Overall Number of Participants Analyzed 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
Systolic, <1.3 doses per migraine
-0.3
(-2.7 to 2.0)
Systolic, 1.3–1.7 doses per migraine
-2.7
(-5.3 to -0.2)
Systolic, >1.7 doses per migraine
-3.8
(-6.2 to -1.5)
Diastolic, <1.3 doses per migraine
-0.4
(-2.2 to 1.5)
Diastolic, 1.3–1.7 doses per migraines
-0.9
(-2.9 to 1.2)
Diastolic, >1.7 doses per migraine
-3.2
(-5.3 to -1.0)
7.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sumatriptan/Naproxen
Hide Arm/Group Description:
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Overall Number of Participants Analyzed 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
Systolic,<6 doses per month
-1.6
(-3.1 to 0.0)
Systolic, 6-10 doses per month
-4.6
(-7.4 to -1.8)
Systolic, >=6 doses per month
-4.3
(-7.1 to -1.6)
Diastolic,<6 doses per month
-1.0
(-2.2 to 0.3)
Diastolic, 6-10 doses per month
-3.7
(-7.1 to -0.4)
Diastolic, >=6 doses per month
-3.5
(-6.3 to -0.7)
8.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sumatriptan/Naproxen
Hide Arm/Group Description:
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Overall Number of Participants Analyzed 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
Systolic, <30 total doses
-1.2
(-2.9 to 0.4)
Systolic, 30-60 total doses
-3.4
(-6.0 to -0.7)
Systolic, >=30 total doses
-3.7
(-6.0 to -1.4)
Diastolic, <30 total doses
-0.6
(-2.0 to 0.7)
Diastolic, 30-60 total doses
-3.3
(-5.8 to -0.8)
Diastolic, >=30 total doses
-3.6
(-5.7 to -1.4)
9.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline to End of Study (6-month study duration)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with valid blood pressure measurements were analyzed.
Arm/Group Title Sumatriptan/Naproxen Sumatriptan Naproxen
Hide Arm/Group Description:
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Sumatriptan 85 mg tablet taken after migraine attack
Naproxen sodium 500 mg tablet taken after migraine attack
Overall Number of Participants Analyzed 120 109 115
Measure Type: Number
Unit of Measure: participants
53 57 63
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Sumatriptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.9 to 2.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Naproxen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.9 to 2.6
Estimation Comments [Not Specified]
10.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline to End of Study (6-month study duration)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with valid blood pressure measurements were analyzed.
Arm/Group Title Sumatriptan/Naproxen Sumatriptan Naproxen
Hide Arm/Group Description:
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Sumatriptan 85 mg tablet taken after migraine attack
Naproxen sodium 500 mg tablet taken after migraine attack
Overall Number of Participants Analyzed 120 109 115
Measure Type: Number
Unit of Measure: participants
72 65 77
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Sumatriptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.6 to 1.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Naproxen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.7 to 2.2
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study
Hide Description 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.
Time Frame Baseline to End of Study (6-month study duration)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Sumatriptan/Naproxen Sumatriptan Naproxen
Hide Arm/Group Description:
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Sumatriptan 85 mg tablet taken after migraine attack
Naproxen sodium 500 mg tablet taken after migraine attack
Overall Number of Participants Analyzed 122 112 118
Measure Type: Number
Unit of Measure: participants
2 2 3
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Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Sumatriptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.1 to 13.6
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Naproxen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
0.3 to 25.6
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg
Hide Description 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.
Time Frame Baseline to End of Study (6-month study duration)
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ITT Population
Arm/Group Title Sumatriptan/Naproxen Sumatriptan Naproxen
Hide Arm/Group Description:
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Sumatriptan 85 mg tablet taken after migraine attack
Naproxen sodium 500 mg tablet taken after migraine attack
Overall Number of Participants Analyzed 122 112 118
Measure Type: Number
Unit of Measure: participants
10 11 11
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Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Sumatriptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
0.5 to 3.7
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Naproxen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
0.6 to 4.2
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure
Hide Description 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.
Time Frame Baseline to End of Study (6-month study duration)
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Hide Analysis Population Description
ITT Population. Only participants with valid blood pressure measurements were analyzed.
Arm/Group Title Sumatriptan/Naproxen Sumatriptan Naproxen
Hide Arm/Group Description:
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Sumatriptan 85 mg tablet taken after migraine attack
Naproxen sodium 500 mg tablet taken after migraine attack
Overall Number of Participants Analyzed 120 109 115
Median (Full Range)
Unit of Measure: days
42.5
(2 to 177)
32.5
(3 to 118)
18.5
(3 to 124)
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Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Sumatriptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.84 to 1.54
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Naproxen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
1.01 to 1.83
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure
Hide Description 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.
Time Frame Baseline to End of Study (6-month study duration)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with valid blood pressure measurements were analyzed.
Arm/Group Title Sumatriptan/Naproxen Sumatriptan Naproxen
Hide Arm/Group Description:
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Sumatriptan 85 mg tablet taken after migraine attack
Naproxen sodium 500 mg tablet taken after migraine attack
Overall Number of Participants Analyzed 120 109 115
Median (Full Range)
Unit of Measure: days
51
(2 to 140)
50.5
(3 to 161)
26
(3 to 124)
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Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Sumatriptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.65 to 1.21
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Sumatriptan/Naproxen, Naproxen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.88 to 1.60
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Number of Participants Withdrawn From the Study Due to Blood Pressure Changes
Hide Description 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.
Time Frame Baseline to End of Study (6-month study duration)
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Hide Analysis Population Description
ITT Population
Arm/Group Title Sumatriptan/Naproxen Sumatriptan Naproxen
Hide Arm/Group Description:
Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Sumatriptan 85 mg tablet taken after migraine attack
Naproxen sodium 500 mg tablet taken after migraine attack
Overall Number of Participants Analyzed 122 112 118
Measure Type: Number
Unit of Measure: participants
1 0 0
Time Frame Serious adverse events (SAEs) and adverse events (AEs) were recorded from the start of investigational product and until any follow-up contact
Adverse Event Reporting Description 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.
 
Arm/Group Title Sumatriptan/Naproxen Sumatriptan Naproxen
Hide Arm/Group Description Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack Sumatriptan 85 mg tablet taken after migraine attack Naproxen sodium 500 mg tablet taken after migraine attack
All-Cause Mortality
Sumatriptan/Naproxen Sumatriptan Naproxen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
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Sumatriptan/Naproxen Sumatriptan Naproxen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/127 (2.36%)   1/120 (0.83%)   0/127 (0.00%) 
General disorders       
Chest pain  1  1/127 (0.79%)  0/120 (0.00%)  0/127 (0.00%) 
Infections and infestations       
Cellulitis  1  1/127 (0.79%)  0/120 (0.00%)  0/127 (0.00%) 
Nervous system disorders       
Convulsion  1  1/127 (0.79%)  0/120 (0.00%)  0/127 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Abortion induced  1  0/127 (0.00%)  1/120 (0.83%)  0/127 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  1/127 (0.79%)  0/120 (0.00%)  0/127 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, v12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Sumatriptan/Naproxen Sumatriptan Naproxen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/127 (15.75%)   29/120 (24.17%)   18/127 (14.17%) 
Gastrointestinal disorders       
Nausea  1  4/127 (3.15%)  2/120 (1.67%)  1/127 (0.79%) 
Immune system disorders       
Seasonal allergy  1  3/127 (2.36%)  1/120 (0.83%)  3/127 (2.36%) 
Infections and infestations       
Nasopharyngitis  1  4/127 (3.15%)  6/120 (5.00%)  5/127 (3.94%) 
Urinary tract infection  1  1/127 (0.79%)  6/120 (5.00%)  3/127 (2.36%) 
Sinusitis  1  3/127 (2.36%)  2/120 (1.67%)  1/127 (0.79%) 
Upper respiratory tract infection  1  0/127 (0.00%)  5/120 (4.17%)  1/127 (0.79%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  2/127 (1.57%)  3/120 (2.50%)  2/127 (1.57%) 
Neck pain  1  2/127 (1.57%)  4/120 (3.33%)  0/127 (0.00%) 
Nervous system disorders       
Dizziness  1  5/127 (3.94%)  5/120 (4.17%)  1/127 (0.79%) 
Somnolence  1  2/127 (1.57%)  3/120 (2.50%)  2/127 (1.57%) 
Respiratory, thoracic and mediastinal disorders       
Sinus congestion  1  0/127 (0.00%)  3/120 (2.50%)  1/127 (0.79%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, v12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00792636     History of Changes
Other Study ID Numbers: 110948
First Submitted: November 17, 2008
First Posted: November 18, 2008
Results First Submitted: October 7, 2010
Results First Posted: November 4, 2010
Last Update Posted: November 23, 2016