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

This study has been completed.

Study NCT00792636 Information provided by GlaxoSmithKline

First Received on November 17, 2008. Last Updated on March 17, 2011 History of Changes

Results First Received: October 7, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Migraine With or Without Aura Migraine Disorders Acute Migraine Migraine Headaches
Interventions:	Drug: sumatriptan and naproxen sodium combination tablet Drug: sumatriptan tablet Drug: naproxen sodium tablet

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The number of participants defined as starting the study in the Participant Flow module includes only those participants randomized to treatment.

Reporting Groups

	Description
Sumatriptan/Naproxen	Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Sumatriptan	Sumatriptan 85 mg tablet taken after migraine attack
Naproxen	Naproxen sodium 500 mg tablet taken after migraine attack

Participant Flow: Overall Study

	Sumatriptan/Naproxen	Sumatriptan	Naproxen
STARTED	135	136	136
COMPLETED	67	55	55
NOT COMPLETED	68	81	81
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

Baseline Characteristics

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Reporting Groups

	Description
Sumatriptan/Naproxen	Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
Sumatriptan	Sumatriptan 85 mg tablet taken after migraine attack
Naproxen	Naproxen sodium 500 mg tablet taken after migraine attack

Baseline Measures

	Sumatriptan/Naproxen	Sumatriptan	Naproxen	Total
Number of Participants [units: participants]	122	112	118	352
Age ^[1] [units: Years] Mean ± Standard Deviation	39.0 ± 11.64	39.8 ± 11.22	39.1 ± 11.92	39.3 ± 11.58
Gender ^[1] [units: Participants]
Female	94	98	96	288
Male	28	14	22	64
Race/Ethnicity, Customized ^[2] [units: 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
Average Number of Migraine Attacks per Month ^[3] [units: migraines] Mean ± Standard Deviation	4.5 ± 1.76	4.2 ± 1.67	4.6 ± 1.8	4.4 ± 1.75

[1]	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.
[2]	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.
[3]	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.

Outcome Measures

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1. Primary:

Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen [ Time Frame: Baseline and Month 6 ]

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2. Secondary:

Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen [ Time Frame: Baseline and Month 6 ]

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3. Secondary:

Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan [ Time Frame: Baseline and Month 6 ]

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4. Secondary:

Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen [ Time Frame: Baseline and Month 6 ]

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5. 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 [ Time Frame: Baseline and Month 6 ]

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6. 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 [ Time Frame: Baseline and Month 6 ]

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7. 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 [ Time Frame: Baseline and Month 6 ]

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8. 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 [ Time Frame: Baseline and Month 6 ]

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9. 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 [ Time Frame: Baseline to End of Study (6-month study duration) ]

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10. 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 [ Time Frame: Baseline to End of Study (6-month study duration) ]

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11. Secondary:

Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study [ Time Frame: Baseline to End of Study (6-month study duration) ]

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12. Secondary:

Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg [ Time Frame: Baseline to End of Study (6-month study duration) ]

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13. Secondary:

Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure [ Time Frame: Baseline to End of Study (6-month study duration) ]

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14. Secondary:

Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure [ Time Frame: Baseline to End of Study (6-month study duration) ]

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15. Secondary:

Number of Participants Withdrawn From the Study Due to Blood Pressure Changes [ Time Frame: Baseline to End of Study (6-month study duration) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00792636 History of Changes
Other Study ID Numbers:	110948
Study First Received:	November 17, 2008
Results First Received:	October 7, 2010
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration