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

This study has been completed.

Study NCT00382993 Information provided by GlaxoSmithKline

First Received on September 29, 2006. Last Updated on April 14, 2011 History of Changes

Results First Received: November 14, 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 Migraine
Interventions:	Drug: Placebo Drug: Combination Product (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/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	84	85
COMPLETED	70 ^[1]	67
NOT COMPLETED	14	18
Lost to Follow-up	7	2
Withdrawal by Subject	1	3
Lack of opportunity to treat migraine	0	5
Did not meet Eligibility Criteria	3	3
Other (no additional data present)	3	5

[1]	Participant considered to have completed period if treated a migraine with investigational product.

Period 2: Migraine Attack 2 (Period 2)

	Placebo/Sumatriptan-Naproxen	Sumatriptan-Naproxen/Placebo
STARTED	70	67
COMPLETED	68	63
NOT COMPLETED	2	4
Lost to Follow-up	1	0
Lack of opportunity to treat migraine	0	1
Did not meet Eligibility Criteria	0	1
Protocol Violation	0	1
Other (no additional data present)	1	1

Baseline Characteristics

Hide Baseline Characteristics

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]	139
Age [units: years] Mean ± Standard Deviation	40.1 ± 11.11
Gender [units: participants]
Female	129
Male	10
Race/Ethnicity, Customized [units: participants]
White/Caucasian/European American	123
African American	10
Other	6

Outcome Measures

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

Migraine Headache Pain Free at 2 Hours Post-Dose [ Time Frame: 2 Hours Post-Dose ]

Show Outcome Measure 2

3. Secondary:

Rescue Medication Use During 0 - 24 Hours Post-Dose [ Time Frame: 0-24 Hours Post-Dose ]

Show Outcome Measure 3

4. Secondary:

Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose [ Time Frame: 0.5, 1, 4, and 8 Hours Post-Dose ]

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

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 ]

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

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 ]

Show Outcome Measure 10

11. Secondary:

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

Show Outcome Measure 11

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 ]

Show Outcome Measure 12

13. Secondary:

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

Show Outcome Measure 13

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 ]

Show Outcome Measure 14

15. Secondary:

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

Show Outcome Measure 15

16. Secondary:

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

Show Outcome Measure 16

17. Secondary:

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

Show Outcome Measure 17

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 ]

Show Outcome Measure 18

19. Secondary:

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

Show Outcome Measure 19

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 centres of a multi-centre 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: Glaxo Smith Kline
phone: 1-866-435-7343

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:	NCT00382993 History of Changes
Other Study ID Numbers:	TRX106573
Study First Received:	September 29, 2006
Results First Received:	November 14, 2008
Last Updated:	April 14, 2011
Health Authority:	United States: Food and Drug Administration