Trial Outcomes & Findings for Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine (NCT NCT01248468)

Last Updated: 2012-07-30

Results Overview

Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

752 participants

Primary outcome timeframe

2 hours

Results posted on

2012-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Aspirin, Acetaminophen, and Caffeine 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets	Sumatriptan (100 mg) 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets	Placebo 1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Overall Study STARTED	299	304	149
Overall Study Safety Population	266	271	133
Overall Study ITT Population	256	261	125
Overall Study COMPLETED	284	290	145
Overall Study NOT COMPLETED	15	14	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Aspirin, Acetaminophen, and Caffeine 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets	Sumatriptan (100 mg) 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets	Placebo 1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Overall Study Administrative problem	1	0	0
Overall Study Lost to Follow-up	9	12	4
Overall Study Pregnancy	1	0	0
Overall Study Withdrawal by Subject	4	2	0

Baseline Characteristics

Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aspirin, Acetaminophen, and Caffeine n=299 Participants 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets	Sumatriptan (100 mg) n=304 Participants 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets	Placebo n=149 Participants 1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets	Total n=752 Participants Total of all reporting groups
Age Continuous	38 years STANDARD_DEVIATION 11.4 • n=5 Participants	37.8 years STANDARD_DEVIATION 11.4 • n=7 Participants	37.6 years STANDARD_DEVIATION 11.5 • n=5 Participants	37.8 years STANDARD_DEVIATION 11.4 • n=4 Participants
Sex: Female, Male Female	250 Participants n=5 Participants	245 Participants n=7 Participants	125 Participants n=5 Participants	620 Participants n=4 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	59 Participants n=7 Participants	24 Participants n=5 Participants	132 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	44 Participants n=5 Participants	47 Participants n=7 Participants	24 Participants n=5 Participants	115 Participants n=4 Participants
Race/Ethnicity, Customized White	244 Participants n=5 Participants	239 Participants n=7 Participants	113 Participants n=5 Participants	596 Participants n=4 Participants
Race/Ethnicity, Customized Other	6 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	299 participants n=5 Participants	304 participants n=7 Participants	149 participants n=5 Participants	752 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Instead, missing values were implicitly imputed by the repeated measures analysis statistical model. So, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.

Outcome measures

Outcome measures
Measure	Aspirin, Acetaminophen, and Caffeine n=248 Participants 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets	Sumatriptan (100 mg) n=256 Participants 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets	Placebo n=121 Participants 1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Percent of Subjects Who Are Pain Free at 2 Hours.	34.7 Percent of participants Interval 0.938 to 2.484	44.9 Percent of participants Interval 0.431 to 0.9	26.4 Percent of participants Interval 1.525 to 3.937

SECONDARY outcome

Timeframe: 2 hours

Population: The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Missing values were implicitly imputed by the repeated measures analysis statistical model. Consequently, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.

Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours

Outcome measures

Outcome measures
Measure	Aspirin, Acetaminophen, and Caffeine n=248 Participants 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets	Sumatriptan (100 mg) n=252 Participants 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets	Placebo n=119 Participants 1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Percent of Subjects Who Are Free of Nausea at 2 Hours.	70.6 percent of participants Interval 0.863 to 2.522	72.2 percent of participants Interval 0.662 to 1.506	66.4 percent of participants Interval 0.856 to 2.549

SECONDARY outcome

Timeframe: 2 hours

Outcome measures

Outcome measures
Measure	Aspirin, Acetaminophen, and Caffeine n=247 Participants 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets	Sumatriptan (100 mg) n=256 Participants 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets	Placebo n=119 Participants 1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Percent of Subjects Who Are Free of Phonophobia at 2 Hours.	53.4 Percent of participants Interval 0.904 to 2.353	60.9 Percent of participants Interval 0.63 to 1.334	46.2 Percent of participants Interval 0.977 to 2.59

SECONDARY outcome

Timeframe: 2 hours

Outcome measures

Outcome measures
Measure	Aspirin, Acetaminophen, and Caffeine n=247 Participants 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets	Sumatriptan (100 mg) n=256 Participants 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets	Placebo n=120 Participants 1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Percent of Subjects Who Are Free of Photophobia at 2 Hours.	48.6 Percent of participants Interval 0.888 to 2.327	52.3 Percent of participants Interval 0.631 to 1.315	40.8 Percent of participants Interval 0.98 to 2.542

Adverse Events

Aspirin, Acetaminophen, and Caffeine

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Sumatriptan (100 mg)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Aspirin, Acetaminophen, and Caffeine n=266 participants at risk 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets	Sumatriptan (100 mg) n=271 participants at risk 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets	Placebo n=133 participants at risk 1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Gastrointestinal disorders Nausea	3.0% 8/266	5.2% 14/271	2.3% 3/133

Additional Information

Clinical Project Leader

Novartis Consumer Health

Phone: 973-503-8000

Results disclosure agreements

Principal investigator is a sponsor employee Data of \&/or resulting from the performance of the Clinical Trial (CT) shall be pooled with the data from other centers \& analyzed as stipulated in the Protocol.Without the consent of the steering committee of the multi-center CT, no presentation/publication of the results obtained from datasets other than the final pooled dataset shall be made prior to the presentation/ publication based on the final pooled dataset.
Publication restrictions are in place

Restriction type: OTHER