Full Text View
Tabular View
Study Results
Related Studies
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
  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
  Hide All Outcome Measures

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 ]

Measure Type Primary
Measure Title Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.
Measure Description Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.
Time Frame 2 hours through 24 hours after Treatment  
Safety Issue No  

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.
The Intent to Treat (ITT) Population was the primary analysis population for assessing efficacy and included subjects who treated at least 1 headache attack with randomized treatment and provided at least one post dose evaluation.

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

Measured Values
  Placebo Sumatriptan/Naproxen
Number of Participants Analyzed
[units: participants] 		221 222
Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.
[units: Participants]
 		   
Pain-Free (2 hours) 25 64
Sustained Pain-Free (2-24 hours) 20 54


Statistical Analysis 1 for Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] <0.001
Percent difference [4] 18
95% Confidence Interval ( 10 to 25 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Pain-Free (2 hours)
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Endpoints were co-primary and both needed to have p-value of <0.05 to be considered indicative of efficacy.
[4] Other relevant estimation information:
  Analysis for Migraine Pain-Free at 2 hours Post-Dose

Statistical Analysis 2 for Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] <0.001
Percent difference [4] 15
95% Confidence Interval ( 8 to 22 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Sustained Pain-Free (2-24 hours)
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Analysis for Sustained Pain Free from 2-24 hours Post-dose



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

Measure Type Secondary
Measure Title Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment
Measure Description Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment.
Time Frame 0.5, 1, and 4 hours after Treatment  
Safety Issue No  

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.
ITT Population

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

Measured Values
  Placebo Sumatriptan/Naproxen
Number of Participants Analyzed
[units: participants] 		221 222
Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment
[units: Participants]
 		   
Pain-free at 4 hours 60 105
Pain-free at 1 hour 16 23
Pain-free at 0.5 hour 6 5

No statistical analysis provided for Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment



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

Measure Type Secondary
Measure Title Sustained Headache Relief 2-24 Hours After Treatment
Measure Description Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication.
Time Frame 2-24 hours after treatment  
Safety Issue No  

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.
ITT Population

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

Measured Values
  Placebo Sumatriptan/Naproxen
Number of Participants Analyzed
[units: participants] 		221 222
Sustained Headache Relief 2-24 Hours After Treatment
[units: Participants]
 		77 110

No statistical analysis provided for Sustained Headache Relief 2-24 Hours After Treatment



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

Measure Type Secondary
Measure Title Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment
Measure Description Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time.
Time Frame 0.5, 1, 2, and 4 hours after treatment  
Safety Issue No  

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.
ITT Population

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

Measured Values
  Placebo Sumatriptan/Naproxen
Number of Participants Analyzed
[units: participants] 		221 222
Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment
[units: Participants]
 		   
Headache relief at 4 hours 108 153
Headache relief at 2 hours 113 124
Headache relief at 1 hour 73 85
Headache relief at 0.5 hour 39 41

No statistical analysis provided for Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment



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

Measure Type Secondary
Measure Title Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment
Measure Description Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack.
Time Frame 0 - 24 hours after treatment  
Safety Issue No  

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.
ITT Population

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

Measured Values
  Placebo Sumatriptan/Naproxen
Number of Participants Analyzed
[units: participants] 		221 222
Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment
[units: Participants]
 		101 61

No statistical analysis provided for Subjects Who Used Rescue Medication From 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   [ 1-2, and 2- 4 hours after treatment ]

Measure Type Secondary
Measure Title Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment
Measure Description Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.)
Time Frame 1-2, and 2- 4 hours after treatment  
Safety Issue No  

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.
ITT Population

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

Measured Values
  Placebo Sumatriptan/Naproxen
Number of Participants Analyzed
[units: participants] 		221 222
Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment
[units: Participants]
 		   
Intermed. Sustained Pain Relief, 2-4 hrs post-dose 92 118
Intermed. Sustained Pain Relief, 1-2 hrs post-dose 67 84

No statistical analysis provided for Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment



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 ]

Measure Type Secondary
Measure Title Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours
Measure Description Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.)
Time Frame 1-2 and 2-4 hours after treatment  
Safety Issue No  

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.
ITT Population

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

Measured Values
  Placebo Sumatriptan/Naproxen
Number of Participants Analyzed
[units: participants] 		221 222
Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours
[units: Participants]
 		   
Intermed. Sustained Pain-free, 2-4 hrs post-dose 22 61
Intermed. Sustained Pain-free, 1-2 hrs post-dose 11 23

No statistical analysis provided for Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours



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 ]

Measure Type Secondary
Measure Title Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment
Measure Description Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.)
Time Frame 2 and 4 hours after treatment  
Safety Issue No  

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.
ITT Population

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

Measured Values
  Placebo Sumatriptan/Naproxen
Number of Participants Analyzed
[units: participants] 		221 222
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment
[units: Participants]
 		   
Headache-Assoc. Neck Pain at 4 hours 93 63
Headache-Assoc. Neck Pain at 2 hours 68 59
Headache-Assoc. Sinus Pain at 4 hours 88 49
Headache-Assoc. Sinus Pain at 2 hours 49 36
Headache-Assoc. Photophobia at 4 hours 87 60
Headache-Assoc. Photophobia at 2 hours 60 46
Headache-Assoc. Phonophobia at 4 hours 83 59
Headache-Assoc. Phonophobia at 2 hours 53 54
Headache-Assoc. Nausea at 4 hours 82 51
Headache-Assoc. Nausea at 2 hours 37 36

No statistical analysis provided for Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment



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

Measure Type Secondary
Measure Title Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score
Measure Description Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction.
Time Frame 0 - 24 hours after treatment  
Safety Issue No  

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.
ITT Population - Actual numbers of subjects who took questionnaire were Placebo 199 and Sumatriptan/Naproxen=188

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

Measured Values
  Placebo Sumatriptan/Naproxen
Number of Participants Analyzed
[units: participants] 		199 188
Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score
[units: Score in scale]
Mean ± Standard Error 		   
Efficacy Adjusted Mean 53 ± 2.0 67 ± 2.0
Functionality Adjusted Mean 56 ± 2.1 70 ± 2.1
Ease-of-Use Adjusted Mean 84 ± 1.3 88 ± 1.3
Bothersome-of-Side Effects Adjusted Mean 94 ± 0.8 91 ± 0.8
Total Score adjusted Mean 64 ± 1.5 75 ± 1.6

No statistical analysis provided for Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score




  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:
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.


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: November 11, 2009
ClinicalTrials.gov Identifier: NCT00387881     History of Changes
Health Authority: United States: Food and Drug Administration





Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services