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: August 5, 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

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Hide Baseline Characteristics

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

Show All Outcome Measures

1. Primary:

Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.

Show Outcome Measure 1

2. Secondary:

Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment

Show Outcome Measure 2

3. Secondary:

Sustained Headache Relief 2-24 Hours After Treatment

Show Outcome Measure 3

4. Secondary:

Headache Relief Over Time Intervals of 4, 2, 1 and 0.5 Hours After Treatment

Show Outcome Measure 4

5. Secondary:

Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment

Show Outcome Measure 5

6. Secondary:

Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment

Show Outcome Measure 6

7. Secondary:

Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours

Show Outcome Measure 7

8. Secondary:

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

Show Outcome Measure 8

9. Secondary:

Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score

Show Outcome Measure 9

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

Results Point of Contact:

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

No publications provided

Study ID Numbers:	TXA107563
Study First Received:	October 11, 2006
Results First Received:	February 19, 2009
Last Updated:	August 5, 2009
ClinicalTrials.gov Identifier:	NCT00387881 History of Changes
Health Authority:	United States: Food and Drug Administration