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NCT01960114 · ClinicalTrials.gov registry record · Phase 2
Study of Long-Acting Acetaminophen in Postoperative Dental Pain
A Phase 2 study, sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC.
- Completed
- Registry status
- Phase 2
- Development phase
- 403
- Enrollment target
NCT01960114: Completed Phase 2 study, sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC.
NCT01960114 is a Phase 2 study that has completed, run by McNeil Consumer Healthcare Division of McNEIL-PPC. The registered enrollment target is 403 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (203% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01960114, a Phase 2 study, has completed, sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 403 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg tablets) in a sub-group of subjects.
Primary Outcome
Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h.
Interventions
- DRUG Placebo
- DRUG Acetaminophen ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 403 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
What the finished NCT01960114 record still lists
NCT01960114 is an interventional study that assigns participants to a tested intervention. The registered 403 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 (203% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01960114 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01960114 about?
NCT01960114 is a clinical study titled "Study of Long-Acting Acetaminophen in Postoperative Dental Pain". The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg tablets) in a sub-group of su...
What is the current status of trial NCT01960114?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 403 participants. The study started on 2013-10. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01960114?
The interventions under investigation include: Placebo (DRUG), Acetaminophen ER (DRUG).
Who is sponsoring clinical trial NCT01960114?
This trial is sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01960114's enrollment target sits among peer trials
403 96th of 2000 higher than 1,905 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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