TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00387881
First received: October 11, 2006
Last updated: July 26, 2012
Last verified: May 2012
Results First Received: February 19, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Migraine, Without Aura
Interventions: Drug: 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 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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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
Total Total of all reporting groups

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.   [ Time Frame: 2 hours through 24 hours after Treatment ]

2.  Secondary:   Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment   [ Time Frame: 0.5, 1, and 4 hours after Treatment ]

3.  Secondary:   Sustained Headache Relief 2-24 Hours After Treatment   [ Time Frame: 2-24 hours after treatment ]

4.  Secondary:   Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment   [ Time Frame: 0.5, 1, 2, and 4 hours after treatment ]

5.  Secondary:   Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment   [ Time Frame: 0 - 24 hours after treatment ]

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications of Results:
Silberstein S, Lipton RB, Goldstein J, Aurora SK, White J, Ochs-Ross R, Lener SE, McDonald SA. Evaluation of a New Fixed-dose Single Tablet of Sumatriptan Formulated with RT Technology and Naproxen Sodium (SumaRT/Nap) for the Acute Treatment of Probable Migraine without Aura. Headache 2008: presented at the American Headache Society Meeting, Boston, MA.


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00387881     History of Changes
Other Study ID Numbers: TXA107563
Study First Received: October 11, 2006
Results First Received: February 19, 2009
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration