TREXIMA (Currently Treximet) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)

This study has been completed.

Study NCT00387881 Information provided by GlaxoSmithKline

First Received: October 11, 2006 Last Updated: November 11, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Condition:	Migraine Disorders
Intervention:	Drug: sumatriptan succinate / naproxen sodium

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	No text entered.
Sumatriptan/Naproxen	Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)

Participant Flow: Overall Study

	Placebo	Sumatriptan/Naproxen
STARTED	334	345
COMPLETED	245	243
NOT COMPLETED	89	102
Lost to Follow-up	23	23
Protocol Violation	2	12
Withdrawal by Subject	15	18
Sponsor terminated Study	0	1
Not eligible	6	7
No opportunity to treat headache	32	34
Not otherwise specified	11	7

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Baseline Characteristics used the Safety Population. Not the Randomised Population
Sumatriptan/Naproxen	Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet. Baseline Characteristics used the Safety Population. Not the Randomised Population

Baseline Measures

	Placebo	Sumatriptan/Naproxen	Total
Number of Participants [units: participants]	246	254	500
Age [units: years] Mean ± Standard Deviation	36.6 ± 11.23	35.8 ± 11.47	36.2 ± 11.35
Gender [units: participants]
Female	176	195	371
Male	70	59	129
Race/Ethnicity, Customized [units: Participants]
African American/African Heritage	28	30	58
American Indian or Alaskan Native	1	0	1
Asian - East Asian Heritage	6	8	14
Asian - Japanese Heritage	2	1	3
Asian - South East Asian Heritage	8	5	13
Native Hawaiian or other Pacific Islander	1	0	1
White - Arabic/North African Heritage	1	2	3
White - White/Caucasian/European Heritage	199	206	405
Mixed race	0	1	1
Missing	0	1	1

Outcome Measures

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1. Primary:

Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. [ 2 hours through 24 hours after Treatment ]

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2. Secondary:

Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment [ 0.5, 1, and 4 hours after Treatment ]

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3. Secondary:

Sustained Headache Relief 2-24 Hours After Treatment [ 2-24 hours after treatment ]

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4. Secondary:

Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment [ 0.5, 1, 2, and 4 hours after treatment ]

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5. Secondary:

Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment [ 0 - 24 hours after treatment ]

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6. Secondary:

Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment [ 1-2, and 2- 4 hours after treatment ]

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7. Secondary:

Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours [ 1-2 and 2-4 hours after treatment ]

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8. Secondary:

Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment [ 2 and 4 hours after treatment ]

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9. Secondary:

Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score [ 0 - 24 hours after treatment ]

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