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

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ClinicalTrials.gov Identifier: NCT01248468
Recruitment Status : Completed
First Posted : November 25, 2010
Results First Posted : July 30, 2012
Last Update Posted : July 30, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pain, Migraine
Interventions Drug: Aspirin, acetaminophen and caffeine
Drug: Sumatriptan
Drug: Placebo
Enrollment 752
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aspirin, Acetaminophen, and Caffeine Sumatriptan (100 mg) Placebo
Hide Arm/Group Description 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets 1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Period Title: Overall Study
Started 299 304 149
Safety Population 266 271 133
ITT Population 256 261 125
Completed 284 290 145
Not Completed 15 14 4
Reason Not Completed
Administrative problem             1             0             0
Lost to Follow-up             9             12             4
Pregnancy             1             0             0
Withdrawal by Subject             4             2             0
Arm/Group Title Aspirin, Acetaminophen, and Caffeine Sumatriptan (100 mg) Placebo Total
Hide Arm/Group Description 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets 1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets Total of all reporting groups
Overall Number of Baseline Participants 299 304 149 752
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 299 participants 304 participants 149 participants 752 participants
38  (11.4) 37.8  (11.4) 37.6  (11.5) 37.8  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants 304 participants 149 participants 752 participants
Female
250
  83.6%
245
  80.6%
125
  83.9%
620
  82.4%
Male
49
  16.4%
59
  19.4%
24
  16.1%
132
  17.6%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 299 participants 304 participants 149 participants 752 participants
American Indian or Alaska Native 1 1 0 2
Asian 3 9 5 17
Native Hawaiian or Other Pacific Islander 1 2 0 3
Black or African American 44 47 24 115
White 244 239 113 596
Other 6 6 7 19
Unknown or Not Reported 0 0 0 0
[1]
Measure Description: Calculation for randomized subjects
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 299 participants 304 participants 149 participants 752 participants
299 304 149 752
1.Primary Outcome
Title Percent of Subjects Who Are Pain Free at 2 Hours.
Hide Description 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
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aspirin, Acetaminophen, and Caffeine Sumatriptan (100 mg) Placebo
Hide Arm/Group Description:
2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Overall Number of Participants Analyzed 248 256 121
Measure Type: Number
Unit of Measure: Percent of participants
34.7 44.9 26.4
2.Secondary Outcome
Title Percent of Subjects Who Are Free of Nausea at 2 Hours.
Hide Description 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
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aspirin, Acetaminophen, and Caffeine Sumatriptan (100 mg) Placebo
Hide Arm/Group Description:
2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Overall Number of Participants Analyzed 248 252 119
Measure Type: Number
Unit of Measure: percent of participants
70.6 72.2 66.4
3.Secondary Outcome
Title Percent of Subjects Who Are Free of Phonophobia at 2 Hours.
Hide Description 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
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aspirin, Acetaminophen, and Caffeine Sumatriptan (100 mg) Placebo
Hide Arm/Group Description:
2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Overall Number of Participants Analyzed 247 256 119
Measure Type: Number
Unit of Measure: Percent of participants
53.4 60.9 46.2
4.Secondary Outcome
Title Percent of Subjects Who Are Free of Photophobia at 2 Hours.
Hide Description 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
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin, Acetaminophen, and Caffeine Sumatriptan (100 mg) Placebo
Hide Arm/Group Description:
2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Overall Number of Participants Analyzed 247 256 120
Measure Type: Number
Unit of Measure: Percent of participants
48.6 52.3 40.8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin, Acetaminophen, and Caffeine Sumatriptan (100 mg) Placebo
Hide Arm/Group Description 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets 1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
All-Cause Mortality
Aspirin, Acetaminophen, and Caffeine Sumatriptan (100 mg) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin, Acetaminophen, and Caffeine Sumatriptan (100 mg) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/266 (0.00%)   0/271 (0.00%)   0/133 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aspirin, Acetaminophen, and Caffeine Sumatriptan (100 mg) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/266 (3.01%)   14/271 (5.17%)   3/133 (2.26%) 
Gastrointestinal disorders       
Nausea  8/266 (3.01%)  14/271 (5.17%)  3/133 (2.26%) 
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.
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.
Results Point of Contact
Name/Title: Clinical Project Leader
Organization: Novartis Consumer Health
Phone: 973-503-8000
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01248468     History of Changes
Other Study ID Numbers: 176-P-401
First Submitted: November 23, 2010
First Posted: November 25, 2010
Results First Submitted: March 22, 2012
Results First Posted: July 30, 2012
Last Update Posted: July 30, 2012