Trial · NCT01973205
Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine
NCT01973205, Phase 3, Completed, Novartis; results first posted 2015-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine. Trials, record NCT01973205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01973205
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine
- NCT number
- NCT01973205
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 900 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Acute Migraine
- Interventions
- Acetaminophen 250 mg and Aspirin 250 mg, Placebo
- First posted
- 2013-10-31
- Last updated
- 2015-06-11
- Results first posted
- 2015-06-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Who Are Pain Free at the 2-hour Assessment | 2 hours | Number of subjects who are pain free at the 2-hour assessment |
| Primary | Number of Subjects Who Are Nausea Free at the 2-hour Assessment | 2 hours | Number of subjects who are nausea free at the 2-hour assessment |
| Secondary | Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment. | 2 hours | Number of subjects who are free of photophobia at the 2-hour assessment. |
| Secondary | Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment. | 2 hours | Number of subjects who are free of phonophobia at the 2-hour assessment. |
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 | Number of Subjects Who Are Pain Free at the 2-hour Assessment | 2 hours | 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). | participants | NUMBER |
| PRIMARY | Number of Subjects Who Are Nausea Free at the 2-hour Assessment | 2 hours | 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). | participants | NUMBER |
| SECONDARY | Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment. | 2 hours | 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). | participants | NUMBER |
| SECONDARY | Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment. | 2 hours | 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). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Who Are Pain Free at the 2-hour Assessment | Placebo | 69 | participants | ||
| Number of Subjects Who Are Pain Free at the 2-hour Assessment | Acetaminophen 250 mg and Aspirin 250 mg | 90 | participants | ||
| Number of Subjects Who Are Nausea Free at the 2-hour Assessment | Placebo | 208 | participants | ||
| Number of Subjects Who Are Nausea Free at the 2-hour Assessment | Acetaminophen 250 mg and Aspirin 250 mg | 244 | participants | ||
| Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment. | Placebo | 116 | participants | ||
| Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment. | Acetaminophen 250 mg and Aspirin 250 mg | 127 | participants | ||
| Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment. | Placebo | 142 | participants | ||
| Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment. | Acetaminophen 250 mg and Aspirin 250 mg | 164 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 453 | |
| Overall Study | STARTED | Acetaminophen 250 mg and Aspirin 250 mg | 447 | |
| Overall Study | COMPLETED | Placebo | 423 | |
| Overall Study | COMPLETED | Acetaminophen 250 mg and Aspirin 250 mg | 425 | |
| Overall Study | NOT COMPLETED | Placebo | 30 | |
| Overall Study | NOT COMPLETED | Acetaminophen 250 mg and Aspirin 250 mg | 22 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | intraductal profilerative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 0 | 415 | 0 |
| serious | intraductal profilerative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Acetaminophen 250 mg and Aspirin 250 mg | 1 | 408 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Acetaminophen 250 mg and Aspirin 250 mg | ||
| Total, other adverse events | Placebo | 0 | 415 |
| Total, other adverse events | Acetaminophen 250 mg and Aspirin 250 mg | 0 | 408 |
| Total, serious adverse events | Placebo | 0 | 415 |
| Total, serious adverse events | Acetaminophen 250 mg and Aspirin 250 mg | 1 | 408 |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Acetaminophen 250 mg and Aspirin 250 mg vs Placebo: Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment. | Trial comparisons |
| Acetaminophen 250 mg and Aspirin 250 mg vs Placebo: Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment. | Trial comparisons |
| Acetaminophen 250 mg and Aspirin 250 mg vs Placebo: Number of Subjects Who Are Pain Free at the 2-hour Assessment | Trial comparisons |
| Acetaminophen 250 mg and Aspirin 250 mg vs Placebo: Number of Subjects Who Are Nausea Free at the 2-hour Assessment | Trial comparisons |
| Acetaminophen 250 mg and Aspirin 250 mg vs Placebo: serious adverse events | Trial comparisons |
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/NCT01973205
GET https://conductscience.org/api/trials/v1/NCT01973205/registered