A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2)

This study has been completed.

Study NCT00383162 Information provided by GlaxoSmithKline

First Received on September 29, 2006. Last Updated on March 17, 2011 History of Changes

Results First Received: October 3, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Migraine With or Without Aura Migraine Disorders Acute Migraine
Interventions:	Drug: Combination Product (sumatriptan succinate / naproxen sodium) Drug: Placebo

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
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Reporting Groups

	Description
Placebo/Sumatriptan-Naproxen	Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
Sumatriptan-Naproxen/Placebo	Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).

Participant Flow for 2 periods

Period 1: Migraine Attack 1 (Period 1)

	Placebo/Sumatriptan-Naproxen	Sumatriptan-Naproxen/Placebo
STARTED	87	86
COMPLETED	67 ^[1]	73 ^[2]
NOT COMPLETED	20	13
No opportunity to treat migraine	3	4
Lost to Follow-up	8	7
Did not meet eligibility criteria	4	2
Withdrawal by Subject	2	0
Non-compliant	3	0

[1]	Participants completing a period treated a migraine with investigational product.
[2]	Participants not completing did not take investigational product.

Period 2: Migraine Attack 2 (Period 2)

	Placebo/Sumatriptan-Naproxen	Sumatriptan-Naproxen/Placebo
STARTED	67	73
COMPLETED	65	66
NOT COMPLETED	2	7
No opportunity to treat migraine 2	1	3
Lost to Follow-up	0	1
Adverse Event	1	0
Unknown reason	0	3

Baseline Characteristics

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Reporting Groups

	Description
Safety Population	Safety Population – Participants who were randomized and who treated at least 1 migraine attack with investigational product.

Baseline Measures

	Safety Population
Number of Participants [units: participants]	144
Age [units: years] Mean ± Standard Deviation	41.1 ± 10.34
Gender [units: participants]
Female	122
Male	22
Race/Ethnicity, Customized [units: participants]
White/Caucasian/European heritage	132
African American/African Heritage	5
East Asian Heritage	1
South East Asian Heritage	2
Arabic/North African Heritage	1
Mixed Race	1
Other - Missing	2

Outcome Measures

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1. Primary:

Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose [ Time Frame: 2 - 24 hours post-dose ]

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2. Secondary:

Pain-Free Assessment at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ]

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3. Secondary:

Rescue Medication Used up to 24 Hours Post-dose [ Time Frame: Dosing to 24 hours post-dose ]

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4. Secondary:

Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose [ Time Frame: 1/2, 1, 4, and 8 hours post-dose ]

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5. Secondary:

Sustained Freedom From Migraine [ Time Frame: 2 - 24 hours post-dose ]

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6. Secondary:

Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose [ Time Frame: 2, 4 , and 8 hours post-dose ]

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7. Secondary:

Sustained Freedom From Migraine-Associated Sinus Pain [ Time Frame: 2 - 24 hours post-dose ]

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8. Secondary:

Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose [ Time Frame: Baseline, 2, 4, and 8 hours post-dose ]

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9. Secondary:

Sustained Freedom From Migraine-Associated Neck Pain [ Time Frame: 2 - 24 hours post-dose ]

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10. Secondary:

Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose [ Time Frame: Baseline, 2, 4, and 8 hours post-dose ]

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11. Secondary:

Sustained Freedom From Migraine-Associated Photophobia [ Time Frame: 2 - 24 hours post-dose ]

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12. Secondary:

Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose [ Time Frame: Baseline, 2, 4, and 8 hours post-dose ]

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13. Secondary:

Sustained Freedom From Migraine-Associated Phonophobia [ Time Frame: 2 - 24 hours post-dose ]

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14. Secondary:

Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose [ Time Frame: Baseline, 2, 4, and 8 hours post-dose ]

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15. Secondary:

Sustained Freedom From Migraine-Associated Nausea [ Time Frame: 2 - 24 hours post-dose ]

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16. Secondary:

Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose [ Time Frame: Baseline, 2, 4, and 8 hours ]

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17. Secondary:

Sustained Complete Pain/Symptom-Free [ Time Frame: 2 - 24 hours post-dose ]

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18. Secondary:

Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose [ Time Frame: Baseline, 2, 4, and 8 hours post-dose ]

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19. Secondary:

Recurrence of Any Migraine Headache Pain [ Time Frame: 24 hours and 48 hours ]

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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

Publications:

Mathew N, Landy S, Tietjen G, Stark S, Runken M, Lener S, Derosier F, and Bukenya D. Evaluation of a single fixed-dose tablet of Sumatriptan 85 mg formulated with RT Technology/Naproxen sodium 500 mg (SumaRT/Nap) in Subjects who Reported Poor Response or Intolerance to Short Acting Triptans for the Acute Treatment of Migraine. Headache 2008: S44-45.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00383162 History of Changes
Other Study ID Numbers:	TRX106571
Study First Received:	September 29, 2006
Results First Received:	October 3, 2008
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration