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Treximet in the Treatment of Chronic Migraine

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: NCT01090050
Recruitment Status : Completed
First Posted : March 19, 2010
Results First Posted : July 3, 2013
Last Update Posted : July 3, 2013
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cady, Roger, M.D.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Migraine
Interventions Drug: Sumatriptan/Naproxen Sodium
Drug: Naproxen Sodium
Enrollment 56
Recruitment Details Recruitment period was from date of Institutional Review Board (IRB) approval (8-3-10) until date last patient enrolled (1-30-12). Subjects were recruited from general population at two clinical research centers.
Pre-assignment Details Subjects completed a 30 day Baseline period between Visit 1 and Visit 2 before Randomization. Subjects must have had 15 or more headache days during the 30 day Baseline period in order to be randomized into the study Treatment periods. Fifty-six subjects were screened for study, however only 28 subjects randomized for treatment due to screen fail.
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue. In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
Period Title: Overall Study
Started 16 12
Completed 15 5
Not Completed 1 7
Reason Not Completed
Lost to Follow-up             0             1
Lack of Efficacy             1             5
Physician Decision             0             1
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium Total
Hide Arm/Group Description In Treatment Period Month 1: Subjects randomized to Treximet will treat daily with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Treximet for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Treximet will be provided with 14 tablets of Treximet to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Treximet per month for rescue. In Treatment Period Month 1: Subjects randomized to naproxen will treat daily with 1 tablet naproxen 500mg per day x 30 days. Subjects will be provided with 30 tablets of naproxen 500mg for rescue. In Treatment Period Months 2 and 3: Subjects randomized to naproxen will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of naproxen 500mg per month for rescue. Total of all reporting groups
Overall Number of Baseline Participants 16 12 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 12 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
12
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 12 participants 28 participants
43.8  (12.6) 37.0  (8.6) 40.9  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 12 participants 28 participants
Female
12
  75.0%
10
  83.3%
22
  78.6%
Male
4
  25.0%
2
  16.7%
6
  21.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 12 participants 28 participants
16 12 28
1.Primary Outcome
Title Percent Change of Migraine Headache Days Compared to Baseline
Hide Description Comparing the number of migraine headache days during Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days 91-120 in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%)
Time Frame Day 121 (following 30 day Baseline Period and Treatment Period days 91-120.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen will treat daily with 1 tablet Sumatriptan/Naproxen per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen will be provided with 14 tablets of Sumatriptan/Naproxen to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen per month for rescue.
In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
Overall Number of Participants Analyzed 15 5
Mean (Standard Deviation)
Unit of Measure: percent migraine headache days per month
-8.06  (32.9) -56.37  (36.2)
2.Secondary Outcome
Title Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline
Hide Description

Comparing number of migraine headache days from Baseline to Treatment Period Months 1, 2, and 3 in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.

Comparing the number of migraine headache days reported from Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days Months 1(days 31-60), 2(days 61-90),and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Each treatment period month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation.

e.g. percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%)

Time Frame Baseline Period (days 1-30) collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
Overall Number of Participants Analyzed 15 5
Mean (Standard Deviation)
Unit of Measure: percent migraine headache days per month
Baseline to Treatment Period Month 1 -26.22  (31.4) -61.55  (23.9)
Baseline to Treatment Period Month 2 -2.96  (23.7) -45.42  (36.0)
Baseline to Treatment Period Month 3 -8.06  (32.9) -56.37  (36.2)
3.Secondary Outcome
Title Migraine Headache Duration From Onset to Pain Free
Hide Description

Comparing mean migraine duration from onset to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation.

e.g. Percent change=[(mean migraine duration from onset to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from onset to pain free during Baseline(days 1-30)/mean duration from onset to pain free during Baseline(days 1-30)]*100%)

Time Frame Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
Overall Number of Participants Analyzed 15 5
Mean (Standard Deviation)
Unit of Measure: percent hours of migraine duration
Baseline to Treatment Period Month 1 167.83  (230.48) 26.37  (13.11)
Baseline to Treatment Period Month 2 176.18  (227.97) 28.91  (21.21)
Baseline to Treatment Period Month 3 151.49  (224.53) 19.65  (30.82)
4.Secondary Outcome
Title Migraine Headache Duration From Time of Treatment to Pain Free
Hide Description

Comparing mean migraine duration from time of treatment to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation.

e.g. Percent change=[(mean migraine duration from time of treatment to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from time of treatment to pain free during Baseline(days 1-30)/mean duration from time of treatment to pain free during Baseline(days 1-30)]*100%)

Time Frame Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
Overall Number of Participants Analyzed 15 5
Mean (Standard Deviation)
Unit of Measure: percent hours of migraine duration
Baseline to Treatment Period Month 1 176.70  (233.18) 24.58  (12.21)
Baseline to Treatment Period Month 2 175.78  (228.08) 28.45  (21.03)
Baseline to Treatment Period Month 3 151.12  (224.45) 23.15  (38.78)
5.Secondary Outcome
Title Migraine Headache Days With Greater Than 50% Reduction
Hide Description Number of subjects with at least 50% reduction in number of migraine headache days reported in Baseline vs. Treatment Period months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.
Time Frame Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
Overall Number of Participants Analyzed 15 5
Measure Type: Number
Unit of Measure: participants
Baseline to Treatment Period Month 1 3 4
Baseline to Treatment Period Month 2 0 3
Baseline to Treatment Period Month 3 3 4
6.Secondary Outcome
Title Percent Change of Doses of Study Medication
Hide Description

Comparing the number of doses of study medication taken during Baseline Period(days 1-30) of triptans(Group A) and non-steroidal anti-inflammatory drugs(NSAIDS)(Group B)to the number of doses of study medication taken during Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.

e.g.Percent change=[(number of doses of study medication during Treatment Period Month 3(days 91-120)-number of doses of study medication during Baseline(days 1-30)/number of doses of study medication during Baseline(days 1-30)]*100%).

Time Frame Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
Overall Number of Participants Analyzed 15 5
Mean (Standard Deviation)
Unit of Measure: percent doses of study medication
Baseline to Treatment Period Month 1 173.8  (194) 825.6  (1649.9)
Baseline to Treatment Period Month 2 40.1  (84) 239.8  (575.8)
Baseline to Treatment Period Month 3 40.0  (147) 135.6  (379.33)
7.Secondary Outcome
Title Migraine Disability Assessment(MIDAS)Questionnaire Total Score
Hide Description

Change in Migraine Disability Assessment (MIDAS) total score (effect migraine headaches have on subjects daily function) from Baseline (Day 31) to 3 months after Baseline to end of Treatment Period Month 3(Day 121) following final dose of study medication in the Sumatriptan/Naproxen Sodium arm vs. the Naproxen Sodium arm.

Total score of disability ranges:

  • 0 to 5, MIDAS Grade I, Little or no disability
  • 6 to 10, MIDAS Grade II, Mild disability
  • 11 to 20, MIDAS Grade III, Moderate disability
  • 21+, MIDAS Grade IV, Severe disability Score ranges from 0-450. No subscales are present.
Time Frame Baseline MIDAS collected at Day 31, Post final dose study at Day 121.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85 mg / naproxen sodium 500 mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500 mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
Overall Number of Participants Analyzed 15 5
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 31 76.6  (38.6) 81.2  (52.9)
Day 121 56.3  (44.5) 16.4  (9.2)
8.Secondary Outcome
Title Compliance With Lifestyle Changes
Hide Description Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Lower scores indicate a better outcome. Higher scores indicate a worse outcome.
Time Frame Day 121
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description:
In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85 mg / naproxen sodium 500 mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500 mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
Overall Number of Participants Analyzed 15 5
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.00  (0.65) 2.40  (0.55)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sumatriptan/Naproxen Sodium Naproxen Sodium
Hide Arm/Group Description In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue. In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
All-Cause Mortality
Sumatriptan/Naproxen Sodium Naproxen Sodium
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sumatriptan/Naproxen Sodium Naproxen Sodium
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/16 (6.25%)      1/12 (8.33%)    
Gastrointestinal disorders     
Cholecystitis   0/16 (0.00%)  0 1/12 (8.33%)  1
Reproductive system and breast disorders     
Menorragia   1/16 (6.25%)  1 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sumatriptan/Naproxen Sodium Naproxen Sodium
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/16 (56.25%)      6/12 (50.00%)    
Cardiac disorders     
Elevated Blood Pressure   1/16 (6.25%)  1 0/12 (0.00%)  0
Ear and labyrinth disorders     
Fluid in Ears   0/16 (0.00%)  0 1/12 (8.33%)  1
Gastrointestinal disorders     
Abdominal Pain   0/16 (0.00%)  0 1/12 (8.33%)  1
Cholecystitis   0/16 (0.00%)  0 1/12 (8.33%)  1
Heartburn   1/16 (6.25%)  1 0/12 (0.00%)  0
Nausea with Fatty Foods   1/16 (6.25%)  1 0/12 (0.00%)  0
Stomach Burn   0/16 (0.00%)  0 1/12 (8.33%)  1
General disorders     
Dizziness   1/16 (6.25%)  1 1/12 (8.33%)  1
Enhanced Smell   0/16 (0.00%)  0 1/12 (8.33%)  1
Pain Behind Eyes   0/16 (0.00%)  0 1/12 (8.33%)  1
Sore Throat   1/16 (6.25%)  1 0/12 (0.00%)  0
Infections and infestations     
Fever   1/16 (6.25%)  1 1/12 (8.33%)  1
Flu   1/16 (6.25%)  1 1/12 (8.33%)  1
Right Leg Ulcer   1/16 (6.25%)  1 0/12 (0.00%)  0
Sinus Infection   0/16 (0.00%)  0 1/12 (8.33%)  1
Strep Throat   1/16 (6.25%)  1 0/12 (0.00%)  0
Upper Respiratory Infection   0/16 (0.00%)  0 1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders     
Muscle pain   1/16 (6.25%)  1 1/12 (8.33%)  4
Right Ankle Sprain   0/16 (0.00%)  0 1/12 (8.33%)  1
Psychiatric disorders     
Worsening Stress   1/16 (6.25%)  1 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Common Cold   2/16 (12.50%)  2 1/12 (8.33%)  1
Cough   0/16 (0.00%)  0 1/12 (8.33%)  1
Sinus Burning Sensation   1/16 (6.25%)  1 0/12 (0.00%)  0
Sinus Discomfort   1/16 (6.25%)  1 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders     
Numb Feeling in Head   1/16 (6.25%)  1 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Jeanne Tarrasch
Organization: Clinvest/A Division of Banyan Group Inc.
Phone: 417-841-3673
Responsible Party: Cady, Roger, M.D.
ClinicalTrials.gov Identifier: NCT01090050     History of Changes
Other Study ID Numbers: 112839
First Submitted: March 18, 2010
First Posted: March 19, 2010
Results First Submitted: February 5, 2013
Results First Posted: July 3, 2013
Last Update Posted: July 3, 2013