Trial · NCT00792636
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
NCT00792636, Phase 4, Completed, GlaxoSmithKline; results first posted 2010-11-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT00792636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00792636
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT00792636
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 407 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Migraine Disorders
- Interventions
- sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, naproxen sodium tablet
- First posted
- 2008-11-18
- Last updated
- 2016-11-23
- Results first posted
- 2010-11-04
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen | Baseline and Month 6 | 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). |
| Secondary | Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen | Baseline and Month 6 | 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). |
| Secondary | Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan | Baseline and Month 6 | 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). |
| Secondary | Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen | Baseline and Month 6 | 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). |
| 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 | Baseline and Month 6 | 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. |
| 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 | Baseline and Month 6 | 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. |
| 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 | Baseline and Month 6 | 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. |
| 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 | Baseline and Month 6 | 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. |
| 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 | Baseline to End of Study (6-month study duration) | 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. |
| 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 | Baseline to End of Study (6-month study duration) | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen | Baseline and Month 6 | 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. | mmHg | MEAN |
| PRIMARY | Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen | Baseline and Month 6 | 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. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan | Baseline and Month 6 | 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. | mmHg | MEAN |
| SECONDARY | Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen | Baseline and Month 6 | 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. | mmHg | MEAN |
| 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 | Baseline and Month 6 | 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. | mmHg | LEAST_SQUARES_MEAN |
| 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 | Baseline and Month 6 | 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. | mmHg | LEAST_SQUARES_MEAN |
| 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 | Baseline and Month 6 | 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. | mmHg | LEAST_SQUARES_MEAN |
| 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 | Baseline and Month 6 | 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. | mmHg | LEAST_SQUARES_MEAN |
| 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 | Baseline to End of Study (6-month study duration) | ITT Population. Only participants with valid blood pressure measurements were analyzed. | participants | NUMBER |
| 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 | Baseline to End of Study (6-month study duration) | ITT Population. Only participants with valid blood pressure measurements were analyzed. | participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group87
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen | Sumatriptan | Systolic, Baseline, n=109, 115 | 110.8 | Standard Deviation 9.15 | mmHg |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen | Naproxen | Systolic, Baseline, n=109, 115 | 110.1 | Standard Deviation 9.19 | mmHg |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen | Sumatriptan | Systolic, Month 6, n=42, 37 | 109.4 | Standard Deviation 7.70 | mmHg |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen | Naproxen | Systolic, Month 6, n=42, 37 | 108.2 | Standard Deviation 9.16 | mmHg |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen | Sumatriptan | Systolic, Change from Baseline, n=41, 36 | -2.8 | Standard Deviation 5.69 | mmHg |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen | Naproxen | Systolic, Change from Baseline, n=41, 36 | -1.8 | Standard Deviation 6.53 | mmHg |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen | Sumatriptan | Diastolic, Baseline, n=109, 115 | 75.7 | Standard Deviation 7.38 | mmHg |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen | Naproxen | Diastolic, Baseline, n=109, 115 | 74.7 | Standard Deviation 7.00 | mmHg |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen | Sumatriptan | Diastolic, Month 6, n=42, 37 | 73.9 | Standard Deviation 7.03 | mmHg |
| Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen | Naproxen | Diastolic, Month 6, n=42, 37 | 74.3 | Standard Deviation 8.47 | mmHg |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sumatriptan/Naproxen | 135 | |
| Overall Study | STARTED | Sumatriptan | 136 | |
| Overall Study | STARTED | Naproxen | 136 | |
| Overall Study | COMPLETED | Sumatriptan/Naproxen | 67 | |
| Overall Study | COMPLETED | Sumatriptan | 55 | |
| Overall Study | COMPLETED | Naproxen | 55 | |
| Overall Study | NOT COMPLETED | Sumatriptan/Naproxen | 68 | |
| Overall Study | NOT COMPLETED | Sumatriptan | 81 | |
| Overall Study | NOT COMPLETED | Naproxen | 81 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Sumatriptan/Naproxen | 4 | 127 | |
| other | Nasopharyngitis | Infections and infestations | Sumatriptan | 6 | 120 | |
| other | Nasopharyngitis | Infections and infestations | Naproxen | 5 | 127 | |
| other | Urinary tract infection | Infections and infestations | Sumatriptan/Naproxen | 1 | 127 | |
| other | Urinary tract infection | Infections and infestations | Sumatriptan | 6 | 120 | |
| other | Urinary tract infection | Infections and infestations | Naproxen | 3 | 127 | |
| other | Sinusitis | Infections and infestations | Sumatriptan/Naproxen | 3 | 127 | |
| other | Sinusitis | Infections and infestations | Sumatriptan | 2 | 120 | |
| other | Sinusitis | Infections and infestations | Naproxen | 1 | 127 | |
| other | Upper respiratory tract infection | Infections and infestations | Sumatriptan/Naproxen | 0 | 127 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sumatriptan/Naproxen | ||
| Total, all-cause mortality | Sumatriptan | ||
| Total, all-cause mortality | Naproxen | ||
| Total, other adverse events | Sumatriptan/Naproxen | 20 | 127 |
| Total, other adverse events | Sumatriptan | 29 | 120 |
| Total, other adverse events | Naproxen | 18 | 127 |
| Total, serious adverse events | Sumatriptan/Naproxen | 3 | 127 |
| Total, serious adverse events | Sumatriptan | 1 | 120 |
| Total, serious adverse events | Naproxen | 0 | 127 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22142350 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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