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NCT01559259 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 394
- Enrollment target
NCT01559259: Completed Phase 2 study, sponsored by Pfizer.
NCT01559259 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 394 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (196% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01559259, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 394 participants
- Enrollment target
Study Summary
This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.
Primary Outcome
SPRID4:Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) based on 4 point categorical severity rating scale (PRID) over 8 hours.SPRID 0-8 score range:-8 (worst score) to 56 (best score).PRID: sum of PRR and PID at each time point.PRID score range:-1= worst score to 7= best score.PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[none\] to 3 \[severe\]) from the baseline pain intensity scores (
Interventions
- DRUG Placebo
- DRUG Ibuprofen
- DRUG Ibuprofen/acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 394 participants |
| Start Date | 2012-04-10 |
| Est. Completion | 2012-09-13 |
| Phase | Phase 2 |
What the finished NCT01559259 record still lists
NCT01559259 is an interventional study that assigns participants to a tested intervention. The registered 394 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (196% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01559259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01559259 about?
NCT01559259 is a clinical study titled "Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain". This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.
What is the current status of trial NCT01559259?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 394 participants. The study started on 2012-04-10. Estimated completion is 2012-09-13.
What interventions are being tested in trial NCT01559259?
The interventions under investigation include: Placebo (DRUG), Ibuprofen (DRUG), Ibuprofen/acetaminophen (DRUG).
Who is sponsoring clinical trial NCT01559259?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01559259's enrollment target sits among peer trials
394 103rd of 2000 higher than 1,897 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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