Trial Outcomes & Findings for Treximet in the Treatment of Chronic Migraine (NCT NCT01090050)
NCT ID: NCT01090050
Last Updated: 2013-07-03
Results Overview
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%)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
56 participants
Primary outcome timeframe
Day 121 (following 30 day Baseline Period and Treatment Period days 91-120.
Results posted on
2013-07-03
Participant Flow
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.
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.
Participant milestones
| Measure |
Sumatriptan/Naproxen Sodium
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.
|
Naproxen Sodium
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 Study
STARTED
|
16
|
12
|
|
Overall Study
COMPLETED
|
15
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
7
|
Reasons for withdrawal
| Measure |
Sumatriptan/Naproxen Sodium
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.
|
Naproxen Sodium
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 Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
5
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Treximet in the Treatment of Chronic Migraine
Baseline characteristics by cohort
| Measure |
Sumatriptan/Naproxen Sodium
n=16 Participants
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.
|
Naproxen Sodium
n=12 Participants
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
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
43.8 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
40.9 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
12 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 121 (following 30 day Baseline Period and Treatment Period days 91-120.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%)
Outcome measures
| Measure |
Naproxen Sodium
n=5 Participants
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.
|
Sumatriptan/Naproxen Sodium
n=15 Participants
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.
|
|---|---|---|
|
Percent Change of Migraine Headache Days Compared to Baseline
|
-56.37 percent migraine headache days per month
Standard Deviation 36.2
|
-8.06 percent migraine headache days per month
Standard Deviation 32.9
|
SECONDARY outcome
Timeframe: Baseline Period (days 1-30) collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121, respectively.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%)
Outcome measures
| Measure |
Naproxen Sodium
n=5 Participants
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.
|
Sumatriptan/Naproxen Sodium
n=15 Participants
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.
|
|---|---|---|
|
Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline
Baseline to Treatment Period Month 1
|
-61.55 percent migraine headache days per month
Standard Deviation 23.9
|
-26.22 percent migraine headache days per month
Standard Deviation 31.4
|
|
Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline
Baseline to Treatment Period Month 2
|
-45.42 percent migraine headache days per month
Standard Deviation 36.0
|
-2.96 percent migraine headache days per month
Standard Deviation 23.7
|
|
Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline
Baseline to Treatment Period Month 3
|
-56.37 percent migraine headache days per month
Standard Deviation 36.2
|
-8.06 percent migraine headache days per month
Standard Deviation 32.9
|
SECONDARY outcome
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.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%)
Outcome measures
| Measure |
Naproxen Sodium
n=5 Participants
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.
|
Sumatriptan/Naproxen Sodium
n=15 Participants
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.
|
|---|---|---|
|
Migraine Headache Duration From Onset to Pain Free
Baseline to Treatment Period Month 1
|
26.37 percent hours of migraine duration
Standard Deviation 13.11
|
167.83 percent hours of migraine duration
Standard Deviation 230.48
|
|
Migraine Headache Duration From Onset to Pain Free
Baseline to Treatment Period Month 2
|
28.91 percent hours of migraine duration
Standard Deviation 21.21
|
176.18 percent hours of migraine duration
Standard Deviation 227.97
|
|
Migraine Headache Duration From Onset to Pain Free
Baseline to Treatment Period Month 3
|
19.65 percent hours of migraine duration
Standard Deviation 30.82
|
151.49 percent hours of migraine duration
Standard Deviation 224.53
|
SECONDARY outcome
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.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%)
Outcome measures
| Measure |
Naproxen Sodium
n=5 Participants
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.
|
Sumatriptan/Naproxen Sodium
n=15 Participants
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.
|
|---|---|---|
|
Migraine Headache Duration From Time of Treatment to Pain Free
Baseline to Treatment Period Month 1
|
24.58 percent hours of migraine duration
Standard Deviation 12.21
|
176.70 percent hours of migraine duration
Standard Deviation 233.18
|
|
Migraine Headache Duration From Time of Treatment to Pain Free
Baseline to Treatment Period Month 2
|
28.45 percent hours of migraine duration
Standard Deviation 21.03
|
175.78 percent hours of migraine duration
Standard Deviation 228.08
|
|
Migraine Headache Duration From Time of Treatment to Pain Free
Baseline to Treatment Period Month 3
|
23.15 percent hours of migraine duration
Standard Deviation 38.78
|
151.12 percent hours of migraine duration
Standard Deviation 224.45
|
SECONDARY outcome
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.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.
Outcome measures
| Measure |
Naproxen Sodium
n=5 Participants
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.
|
Sumatriptan/Naproxen Sodium
n=15 Participants
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.
|
|---|---|---|
|
Migraine Headache Days With Greater Than 50% Reduction
Baseline to Treatment Period Month 1
|
4 participants
|
3 participants
|
|
Migraine Headache Days With Greater Than 50% Reduction
Baseline to Treatment Period Month 2
|
3 participants
|
0 participants
|
|
Migraine Headache Days With Greater Than 50% Reduction
Baseline to Treatment Period Month 3
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.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%).
Outcome measures
| Measure |
Naproxen Sodium
n=5 Participants
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.
|
Sumatriptan/Naproxen Sodium
n=15 Participants
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.
|
|---|---|---|
|
Percent Change of Doses of Study Medication
Baseline to Treatment Period Month 1
|
825.6 percent doses of study medication
Standard Deviation 1649.9
|
173.8 percent doses of study medication
Standard Deviation 194
|
|
Percent Change of Doses of Study Medication
Baseline to Treatment Period Month 2
|
239.8 percent doses of study medication
Standard Deviation 575.8
|
40.1 percent doses of study medication
Standard Deviation 84
|
|
Percent Change of Doses of Study Medication
Baseline to Treatment Period Month 3
|
135.6 percent doses of study medication
Standard Deviation 379.33
|
40.0 percent doses of study medication
Standard Deviation 147
|
SECONDARY outcome
Timeframe: Baseline MIDAS collected at Day 31, Post final dose study at Day 121.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.
Outcome measures
| Measure |
Naproxen Sodium
n=5 Participants
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.
|
Sumatriptan/Naproxen Sodium
n=15 Participants
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.
|
|---|---|---|
|
Migraine Disability Assessment(MIDAS)Questionnaire Total Score
Day 31
|
81.2 scores on a scale
Standard Deviation 52.9
|
76.6 scores on a scale
Standard Deviation 38.6
|
|
Migraine Disability Assessment(MIDAS)Questionnaire Total Score
Day 121
|
16.4 scores on a scale
Standard Deviation 9.2
|
56.3 scores on a scale
Standard Deviation 44.5
|
SECONDARY outcome
Timeframe: Day 121Self-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.
Outcome measures
| Measure |
Naproxen Sodium
n=5 Participants
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.
|
Sumatriptan/Naproxen Sodium
n=15 Participants
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.
|
|---|---|---|
|
Compliance With Lifestyle Changes
|
2.40 Units on a scale
Standard Deviation 0.55
|
2.00 Units on a scale
Standard Deviation 0.65
|
Adverse Events
Sumatriptan/Naproxen Sodium
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Naproxen Sodium
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sumatriptan/Naproxen Sodium
n=16 participants at risk
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.
|
Naproxen Sodium
n=12 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Cholecystitis
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Reproductive system and breast disorders
Menorragia
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
Other adverse events
| Measure |
Sumatriptan/Naproxen Sodium
n=16 participants at risk
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.
|
Naproxen Sodium
n=12 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Cholecystitis
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Common Cold
|
12.5%
2/16 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Dizziness
|
6.2%
1/16 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Cardiac disorders
Elevated Blood Pressure
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Enhanced Smell
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Fever
|
6.2%
1/16 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Flu
|
6.2%
1/16 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Ear and labyrinth disorders
Fluid in Ears
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
6.2%
1/16 • Number of events 1
|
8.3%
1/12 • Number of events 4
|
|
Gastrointestinal disorders
Nausea with Fatty Foods
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Numb Feeling in Head
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Pain Behind Eyes
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Right Ankle Sprain
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Right Leg Ulcer
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Burning Sensation
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Discomfort
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Sinus Infection
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Sore Throat
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Stomach Burn
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Strep Throat
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Psychiatric disorders
Worsening Stress
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
Additional Information
Jeanne Tarrasch
Clinvest/A Division of Banyan Group Inc.
Phone: 417-841-3673
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60