Trial · NCT01248468
Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine
NCT01248468, Phase 4, Completed, Novartis; results first posted 2012-07-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine. Trials, record NCT01248468. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01248468
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine
- NCT number
- NCT01248468
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 752 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Pain, Migraine
- Interventions
- Aspirin, acetaminophen and caffeine, Sumatriptan, Placebo
- First posted
- 2010-11-25
- Last updated
- 2012-07-30
- Results first posted
- 2012-07-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Subjects Who Are Pain Free at 2 Hours. | 2 hours | 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 |
| Secondary | Percent of Subjects Who Are Free of Nausea at 2 Hours. | 2 hours | 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 |
| Secondary | Percent of Subjects Who Are Free of Phonophobia at 2 Hours. | 2 hours | 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 |
| Secondary | Percent of Subjects Who Are Free of Photophobia at 2 Hours. | 2 hours | 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 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Subjects Who Are Pain Free at 2 Hours. | 2 hours | 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. | Percent of participants | NUMBER |
| SECONDARY | Percent of Subjects Who Are Free of Nausea at 2 Hours. | 2 hours | 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. | percent of participants | NUMBER |
| SECONDARY | Percent of Subjects Who Are Free of Phonophobia at 2 Hours. | 2 hours | 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. | Percent of participants | NUMBER |
| SECONDARY | Percent of Subjects Who Are Free of Photophobia at 2 Hours. | 2 hours | Percent of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Subjects Who Are Pain Free at 2 Hours. | Aspirin, Acetaminophen, and Caffeine | 34.7 | .938 to 2.484 | Percent of participants | |
| Percent of Subjects Who Are Pain Free at 2 Hours. | Sumatriptan (100 mg) | 44.9 | 0.431 to .900 | Percent of participants | |
| Percent of Subjects Who Are Pain Free at 2 Hours. | Placebo | 26.4 | 1.525 to 3.937 | Percent of participants | |
| Percent of Subjects Who Are Free of Nausea at 2 Hours. | Aspirin, Acetaminophen, and Caffeine | 70.6 | .863 to 2.522 | percent of participants | |
| Percent of Subjects Who Are Free of Nausea at 2 Hours. | Sumatriptan (100 mg) | 72.2 | .662 to 1.506 | percent of participants | |
| Percent of Subjects Who Are Free of Nausea at 2 Hours. | Placebo | 66.4 | .856 to 2.549 | percent of participants | |
| Percent of Subjects Who Are Free of Phonophobia at 2 Hours. | Aspirin, Acetaminophen, and Caffeine | 53.4 | .904 to 2.353 | Percent of participants | |
| Percent of Subjects Who Are Free of Phonophobia at 2 Hours. | Sumatriptan (100 mg) | 60.9 | .630 to 1.334 | Percent of participants | |
| Percent of Subjects Who Are Free of Phonophobia at 2 Hours. | Placebo | 46.2 | .977 to 2.590 | Percent of participants | |
| Percent of Subjects Who Are Free of Photophobia at 2 Hours. | Aspirin, Acetaminophen, and Caffeine | 48.6 | .888 to 2.327 | Percent of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aspirin, Acetaminophen, and Caffeine | 299 | |
| Overall Study | STARTED | Sumatriptan (100 mg) | 304 | |
| Overall Study | STARTED | Placebo | 149 | |
| Overall Study | Safety Population | Aspirin, Acetaminophen, and Caffeine | 266 | |
| Overall Study | Safety Population | Sumatriptan (100 mg) | 271 | |
| Overall Study | Safety Population | Placebo | 133 | |
| Overall Study | ITT Population | Aspirin, Acetaminophen, and Caffeine | 256 | |
| Overall Study | ITT Population | Sumatriptan (100 mg) | 261 | |
| Overall Study | ITT Population | Placebo | 125 | |
| Overall Study | COMPLETED | Aspirin, Acetaminophen, and Caffeine | 284 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Aspirin, Acetaminophen, and Caffeine | 8 | 266 | |
| other | Nausea | Gastrointestinal disorders | Sumatriptan (100 mg) | 14 | 271 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 133 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aspirin, Acetaminophen, and Caffeine | ||
| Total, all-cause mortality | Sumatriptan (100 mg) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Aspirin, Acetaminophen, and Caffeine | 8 | 266 |
| Total, other adverse events | Sumatriptan (100 mg) | 14 | 271 |
| Total, other adverse events | Placebo | 3 | 133 |
| Total, serious adverse events | Aspirin, Acetaminophen, and Caffeine | 0 | 266 |
| Total, serious adverse events | Sumatriptan (100 mg) | 0 | 271 |
| Total, serious adverse events | Placebo | 0 | 133 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01248468
GET https://conductscience.org/api/trials/v1/NCT01248468/registered