Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01086358
Recruitment Status : Completed
First Posted : March 15, 2010
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborators:
GlaxoSmithKline
Pernix Theraputics LLC
Information provided by (Responsible Party):
Jennifer Kriegler, MD, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Workplace Migraine Treatment
Interventions Drug: Triptan
Drug: Treximet 85Mg-500Mg Tablet
Enrollment 60
Recruitment Details 60 Subjects who are employed in a paying job, who have episodic migraine (<15 days/month), who are using an acute care triptan monotherapy for their migraine (excluding combinations of any sort, such as acetaminophen [APAP] and non-steoridals [NSAIDs]) and who have no contraindications to triptan or NSAID use.
Pre-assignment Details This study had no wash-out or run-in phase.
Arm/Group Title Usual Prescribed Triptan First Treximet Arm First
Hide Arm/Group Description Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 60, with 30 in each sequence, would power the study at 86%.

Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.

Treximet for migraine treatment: Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%.

Period Title: First Intervention
Started 30 [1] 29 [2]
Completed 21 24
Not Completed 9 5
Reason Not Completed
Lost to Follow-up             9             4
Withdrawal by Subject             0             1
[1]
30 subjects enrolled.
[2]
30 subjects enrolled, 1 withdrew before randomization
Period Title: Second Intervention
Started 21 24
Completed 17 20
Not Completed 4 4
Reason Not Completed
Lost to Follow-up             4             4
Arm/Group Title All Completed Study Participants
Hide Arm/Group Description

Participants received their usual prescribed triptan or Treximet, depending on the randomization schedule.

Usual prescribed triptan: usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan

Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants
41.4  (9.4)
[1]
Measure Analysis Population Description: Subjects were lost to follow-up or withdrew consent.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
33
  89.2%
Male
4
  10.8%
[1]
Measure Analysis Population Description: Not all subjects completed both study arms.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   8.1%
White
34
  91.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
[1]
Measure Analysis Population Description: 37 patients completed both phases of the study and make up the primary data set.
1.Primary Outcome
Title Workplace Productivity and Activity Impairment Scale (WPAI).
Hide Description The primary outcome measure was lost productivity (workplace productivity + non-workplace activity time) as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
This includes all patients that completed all study visits are included in this efficacy analysis
Arm/Group Title Arm 1 - Triptan Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm
Hide Arm/Group Description:

Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.

Arm 1 Triptan: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan

Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.

Arm 2 - Sumatriptan/naproxen sodium (Treximet): Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg

Overall Number of Participants Analyzed 37 37
Mean (95% Confidence Interval)
Unit of Measure: hours
4.15
(2.93 to 5.36)
2.44
(1.23 to 3.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 - Triptan, Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm
Comments Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Mixed Models Analysis
Comments As noted above, results are adjusted for study period and treatment order
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.71
Confidence Interval (2-Sided) 95%
-2.92 to -0.49
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Lost Workplace Productivity
Hide Description This outcome measure was lost workplace productivity as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months.The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
This includes all patients that completed all study visits are included in this efficacy analysis
Arm/Group Title Arm 1 - Triptan Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm
Hide Arm/Group Description:

Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.

Arm 1 Triptan: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan

Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.

Arm 2 - Sumatriptan/naproxen sodium (Treximet): Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg

Overall Number of Participants Analyzed 37 37
Mean (95% Confidence Interval)
Unit of Measure: hours
2.25
(1.60 to 2.90)
1.23
(0.58 to 1.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 - Triptan, Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm
Comments Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Mixed Models Analysis
Comments As noted above, results are adjusted for study period and treatment order
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.03
Confidence Interval (2-Sided) 95%
-1.79 to -0.27
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Lost Activity Time
Hide Description This outcome measure was lost activity time as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months.The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
This includes all patients that completed all study visits are included in this efficacy analysis
Arm/Group Title Arm 1 - Triptan Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm
Hide Arm/Group Description:

Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.

Arm 1 Triptan: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan

Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.

Arm 2 - Sumatriptan/naproxen sodium (Treximet): Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg

Overall Number of Participants Analyzed 37 37
Mean (95% Confidence Interval)
Unit of Measure: hours
1.89
(1.19 to 2.60)
1.22
(0.51 to 1.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 - Triptan, Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm
Comments Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method Mixed Models Analysis
Comments As noted above, results are adjusted for study period and treatment order.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-1.39 to 0.03
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Favorable Response on Migraine-ACT
Hide Description The Migraine-ACT is a 4-item scale with yes/no responses. A score of 3 or more is considered favorable. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The Migraine-ACT is reported as a binary measure (3 or more positive responses). The outcome presented included the percentage with a score of 3 or more, and the Odds ratio comparing the two treatments.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Triptan Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm
Hide Arm/Group Description:

Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.

Arm 1 Triptan: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan

Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.

Arm 2 - Sumatriptan/naproxen sodium (Treximet): Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg

Overall Number of Participants Analyzed 37 37
Mean (95% Confidence Interval)
Unit of Measure: percentage of favorable responses
46
(30 to 63)
71
(54 to 84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 - Triptan, Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm
Comments Logistic regression models with generalized estimating equations were used. In these models, a logit link function was used for a favorable response (yes/no) with treatment as the primary fixed effect and including study period and treatment order as other fixed effects..
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Regression, Logistic
Comments As noted above, results are adjusted for study period and treatment order.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.89
Confidence Interval (2-Sided) 95%
1.22 to 6.84
Estimation Comments [Not Specified]
Time Frame Approximately 6 months
Adverse Event Reporting Description Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.
 
Arm/Group Title Usual Prescribed Triptan Treximet Arm
Hide Arm/Group Description Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%.

Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule.

Treximet for migraine treatment: Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%.

All-Cause Mortality
Usual Prescribed Triptan Treximet Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Usual Prescribed Triptan Treximet Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Prescribed Triptan Treximet Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   18/45 (40.00%)   15/45 (33.33%) 
Gastrointestinal disorders     
Nausea * 1  5/45 (11.11%)  6/45 (13.33%) 
General disorders     
Fatigue * 1  4/45 (8.89%)  1/45 (2.22%) 
Chest Discomfort * 1  1/45 (2.22%)  1/45 (2.22%) 
Irritability * 1  1/45 (2.22%)  0/45 (0.00%) 
Xerostomia * 1 [1]  2/45 (4.44%)  0/45 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle weakness * 1  1/45 (2.22%)  0/45 (0.00%) 
Nervous system disorders     
Somnolence * 1 [2]  8/45 (17.78%)  4/45 (8.89%) 
Lightheadedness * 1 [3]  4/45 (8.89%)  1/45 (2.22%) 
Giddiness * 1 [4]  1/45 (2.22%)  1/45 (2.22%) 
Apraxia * 1 [5]  1/45 (2.22%)  1/45 (2.22%) 
Paresthesia * 1  1/45 (2.22%)  0/45 (0.00%) 
Renal and urinary disorders     
Bladder pain * 1  0/45 (0.00%)  1/45 (2.22%) 
1
Term from vocabulary, Other
*
Indicates events were collected by non-systematic assessment
[1]
dry mouth and jaw tightness
[2]
Sleepiness
[3]
Lightheaded, head pressure and tightness and head rush, diaphoresis
[4]
Loopiness and Dopey
[5]
Word finding difficulty
Unusually high number of subjects lost to follow-up.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Jennifer Kriegler, MD
Organization: Cleveland Clinic Foundation
Phone: 216-444-8265
Responsible Party: Jennifer Kriegler, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01086358     History of Changes
Other Study ID Numbers: 09-602
First Submitted: March 11, 2010
First Posted: March 15, 2010
Results First Submitted: December 21, 2017
Results First Posted: May 1, 2018
Last Update Posted: May 1, 2018