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

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ClinicalTrials.gov Identifier: NCT00387881
Recruitment Status : Completed
First Posted : October 13, 2006
Results First Posted : July 10, 2009
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine, Without Aura
Interventions Drug: sumatriptan succinate / naproxen sodium
Drug: Placebo
Enrollment 679
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Sumatriptan/Naproxen
Hide Arm/Group Description [Not Specified] Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Period Title: Overall Study
Started 334 345
Completed 245 243
Not Completed 89 102
Reason Not Completed
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
Arm/Group Title Placebo Sumatriptan/Naproxen Total
Hide Arm/Group Description Baseline Characteristics used the Safety Population. Not the Randomised Population Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet. Baseline Characteristics used the Safety Population. Not the Randomised Population Total of all reporting groups
Overall Number of Baseline Participants 246 254 500
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 246 participants 254 participants 500 participants
36.6  (11.23) 35.8  (11.47) 36.2  (11.35)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants 254 participants 500 participants
Female
176
  71.5%
195
  76.8%
371
  74.2%
Male
70
  28.5%
59
  23.2%
129
  25.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 246 participants 254 participants 500 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
1.Primary Outcome
Title Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan/Naproxen
Hide Arm/Group Description:
[Not Specified]
Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Overall Number of Participants Analyzed 221 222
Measure Type: Number
Unit of Measure: Participants
Pain-Free (2 hours) 25 64
Sustained Pain-Free (2-24 hours) 20 54
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sumatriptan/Naproxen
Comments Pain-Free (2 hours)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Endpoints were co-primary and both needed to have p-value of <0.05 to be considered indicative of efficacy.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 18
Confidence Interval 95%
10 to 25
Estimation Comments Analysis for Migraine Pain-Free at 2 hours Post-Dose
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sumatriptan/Naproxen
Comments Sustained Pain-Free (2-24 hours)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 15
Confidence Interval 95%
8 to 22
Estimation Comments Analysis for Sustained Pain Free from 2-24 hours Post-dose
2.Secondary Outcome
Title Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Sumatriptan/Naproxen
Hide Arm/Group Description:
[Not Specified]
Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Overall Number of Participants Analyzed 221 222
Measure Type: Number
Unit of Measure: Participants
Pain-free at 4 hours 60 105
Pain-free at 1 hour 16 23
Pain-free at 0.5 hour 6 5
3.Secondary Outcome
Title Sustained Headache Relief 2-24 Hours After Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Sumatriptan/Naproxen
Hide Arm/Group Description:
[Not Specified]
Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Overall Number of Participants Analyzed 221 222
Measure Type: Number
Unit of Measure: Participants
77 110
4.Secondary Outcome
Title Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Sumatriptan/Naproxen
Hide Arm/Group Description:
[Not Specified]
Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Overall Number of Participants Analyzed 221 222
Measure Type: Number
Unit of Measure: 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
5.Secondary Outcome
Title Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment
Time Frame 0 - 24 hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Sumatriptan/Naproxen
Hide Arm/Group Description:
[Not Specified]
Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Overall Number of Participants Analyzed 221 222
Measure Type: Number
Unit of Measure: Participants
101 61
6.Secondary Outcome
Title Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Sumatriptan/Naproxen
Hide Arm/Group Description:
[Not Specified]
Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Overall Number of Participants Analyzed 221 222
Measure Type: Number
Unit of Measure: Participants
Intermed. Sustained Pain Relief, 2-4 hrs post-dose 92 118
Intermed. Sustained Pain Relief, 1-2 hrs post-dose 67 84
7.Secondary Outcome
Title Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Sumatriptan/Naproxen
Hide Arm/Group Description:
[Not Specified]
Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Overall Number of Participants Analyzed 221 222
Measure Type: Number
Unit of Measure: Participants
Intermed. Sustained Pain-free, 2-4 hrs post-dose 22 61
Intermed. Sustained Pain-free, 1-2 hrs post-dose 11 23
8.Secondary Outcome
Title Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Sumatriptan/Naproxen
Hide Arm/Group Description:
[Not Specified]
Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Overall Number of Participants Analyzed 221 222
Measure Type: Number
Unit of Measure: 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
9.Secondary Outcome
Title Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population - Actual numbers of subjects who took questionnaire were Placebo 199 and Sumatriptan/Naproxen=188
Arm/Group Title Placebo Sumatriptan/Naproxen
Hide Arm/Group Description:
[Not Specified]
Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Overall Number of Participants Analyzed 199 188
Mean (Standard Error)
Unit of Measure: Score in scale
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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Sumatriptan/Naproxen
Hide Arm/Group Description [Not Specified] Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
All-Cause Mortality
Placebo Sumatriptan/Naproxen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Sumatriptan/Naproxen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/246 (0.00%)   0/254 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Sumatriptan/Naproxen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/246 (0.00%)   0/254 (0.00%) 
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.
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.
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
First Submitted: October 11, 2006
First Posted: October 13, 2006
Results First Submitted: February 19, 2009
Results First Posted: July 10, 2009
Last Update Posted: December 16, 2016