Trial Outcomes & Findings for Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine (NCT NCT01973205)
NCT ID: NCT01973205
Last Updated: 2015-06-11
Results Overview
Number of subjects who are pain free at the 2-hour assessment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
900 participants
Primary outcome timeframe
2 hours
Results posted on
2015-06-11
Participant Flow
Participant milestones
| Measure |
Placebo
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
|
Acetaminophen 250 mg and Aspirin 250 mg
2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
|
|---|---|---|
|
Overall Study
STARTED
|
453
|
447
|
|
Overall Study
COMPLETED
|
423
|
425
|
|
Overall Study
NOT COMPLETED
|
30
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine
Baseline characteristics by cohort
| Measure |
Placebo
n=453 Participants
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
|
Acetaminophen 250 mg and Aspirin 250 mg
n=447 Participants
2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
|
Total
n=900 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 12.4 • n=39 Participants
|
39.7 years
STANDARD_DEVIATION 12.8 • n=41 Participants
|
40.1 years
STANDARD_DEVIATION 12.6 • n=35 Participants
|
|
Sex: Female, Male
Female
|
351 Participants
n=39 Participants
|
350 Participants
n=41 Participants
|
701 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=39 Participants
|
97 Participants
n=41 Participants
|
199 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
48 Participants
n=39 Participants
|
48 Participants
n=41 Participants
|
96 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
405 Participants
n=39 Participants
|
399 Participants
n=41 Participants
|
804 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
96 Participants
n=39 Participants
|
105 Participants
n=41 Participants
|
201 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
337 Participants
n=39 Participants
|
318 Participants
n=41 Participants
|
655 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
453 participants
n=39 Participants
|
447 participants
n=41 Participants
|
900 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing pain free status at 2 hours (AA: N=408, Placebo: N = 415).
Number of subjects who are pain free at the 2-hour assessment
Outcome measures
| Measure |
Placebo
n=415 Participants
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
|
Acetaminophen 250 mg and Aspirin 250 mg
n=408 Participants
2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
|
|---|---|---|
|
Number of Subjects Who Are Pain Free at the 2-hour Assessment
|
69 participants
|
90 participants
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N=415) and had a non-missing nausea free status at 2 hours (AA: N=403, Placebo N= 411).
Number of subjects who are nausea free at the 2-hour assessment
Outcome measures
| Measure |
Placebo
n=411 Participants
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
|
Acetaminophen 250 mg and Aspirin 250 mg
n=403 Participants
2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
|
|---|---|---|
|
Number of Subjects Who Are Nausea Free at the 2-hour Assessment
|
208 participants
|
244 participants
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing photophobia free status at 2 hours (AA: N=403, Placebo: N = 411).
Number of subjects who are free of photophobia at the 2-hour assessment.
Outcome measures
| Measure |
Placebo
n=411 Participants
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
|
Acetaminophen 250 mg and Aspirin 250 mg
n=403 Participants
2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
|
|---|---|---|
|
Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.
|
116 participants
|
127 participants
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing phonophobia free status at 2 hours (AA: N=403, Placebo: N = 411).
Number of subjects who are free of phonophobia at the 2-hour assessment.
Outcome measures
| Measure |
Placebo
n=411 Participants
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
|
Acetaminophen 250 mg and Aspirin 250 mg
n=403 Participants
2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
|
|---|---|---|
|
Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.
|
142 participants
|
164 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acetaminophen 250 mg and Aspirin 250 mg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=415 participants at risk
2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
|
Acetaminophen 250 mg and Aspirin 250 mg
n=408 participants at risk
2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg
Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
intraductal profilerative breast lesion
|
0.00%
0/415
Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415)
|
0.25%
1/408 • Number of events 1
Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415)
|
Other adverse events
Adverse event data not reported
Additional Information
Clinical Project Leader
Novartis
Phone: 9735038000
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor shall review results communications prior to public release to evaluate the manuscript for accuracy, ascertain whether information (other than the results of the Clinical Trial) is being improperly disclosed, provided information which may have not have yet been made available by the Sponsor, provide input for consideration regarding the content and/or conclusion(s) of the manuscript and determine whether the manuscript discloses any potentially patentable invention(s).
- Publication restrictions are in place
Restriction type: OTHER