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NCT05761574 · ClinicalTrials.gov registry record · Phase 3
A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain
A Phase 3 study, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 447
- Enrollment target
NCT05761574: Completed Phase 3 study, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
NCT05761574 is a Phase 3 study that has completed, run by Johnson & Johnson Consumer Inc. (J&JCI). The registered enrollment target is 447 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05761574, a Phase 3 study, has completed, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 447 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.
Primary Outcome
Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.
Interventions
- DRUG Placebo
- DRUG Acetaminophen
- DRUG Naproxen Sodium
- DRUG Acetaminophen/Naproxen Sodium Fixed Combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 447 participants |
| Start Date | 2023-05-22 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 3 |
What the finished NCT05761574 record still lists
NCT05761574 is an interventional study that assigns participants to a tested intervention. The registered 447 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05761574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05761574 about?
NCT05761574 is a clinical study titled "A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain". The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.
What is the current status of trial NCT05761574?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 447 participants. The study started on 2023-05-22. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT05761574?
The interventions under investigation include: Placebo (DRUG), Acetaminophen (DRUG), Naproxen Sodium (DRUG), Acetaminophen/Naproxen Sodium Fixed Combination (DRUG).
Who is sponsoring clinical trial NCT05761574?
This trial is sponsored by Johnson & Johnson Consumer Inc. (J&JCI), which has 40 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05761574's enrollment target sits among peer trials
447 864th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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