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NCT01248468 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine
A Phase 4 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 752
- Enrollment target
NCT01248468: Completed Phase 4 study, sponsored by Novartis.
NCT01248468 is a Phase 4 study that has completed, run by Novartis. The registered enrollment target is 752 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01248468, a Phase 4 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 752 participants
- Enrollment target
Study Summary
The main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of migraine.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Sumatriptan
- DRUG Aspirin, acetaminophen and caffeine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 752 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-03 |
| Phase | Phase 4 |
What the finished NCT01248468 record still lists
NCT01248468 is an interventional study that assigns participants to a tested intervention. The registered 752 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01248468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01248468 about?
NCT01248468 is a clinical study titled "Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine". The main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of migraine.
What is the current status of trial NCT01248468?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 752 participants. The study started on 2010-11. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01248468?
The interventions under investigation include: Placebo (DRUG), Sumatriptan (DRUG), Aspirin, acetaminophen and caffeine (DRUG).
Who is sponsoring clinical trial NCT01248468?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01248468's enrollment target sits among peer trials
752 107th of 2000 higher than 1,894 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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