Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05868122 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
A Phase 3 study, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 143
- Enrollment target
NCT05868122: Completed Phase 3 study, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
NCT05868122 is a Phase 3 study that has completed, run by Johnson & Johnson Consumer Inc. (J&JCI). The registered enrollment target is 143 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05868122, a Phase 3 study, has completed, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 143 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate effectiveness of a fixed combination of acetaminophen/naproxen sodium compared with placebo for reduction of pain when administered as multiple doses over a 48-hour period.
Primary Outcome
Time-weighted 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/Naproxen Sodium Fixed Combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2023-09-07 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 3 |
What the finished NCT05868122 record still lists
NCT05868122 is an interventional study that assigns participants to a tested intervention. The registered 143 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 (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05868122 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05868122 about?
NCT05868122 is a clinical study titled "A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy". The purpose of this study is to evaluate effectiveness of a fixed combination of acetaminophen/naproxen sodium compared with placebo for reduction of pain when administered as multiple doses over a 48-hour period.
What is the current status of trial NCT05868122?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 143 participants. The study started on 2023-09-07. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT05868122?
The interventions under investigation include: Placebo (DRUG), Acetaminophen/Naproxen Sodium Fixed Combination (DRUG).
Who is sponsoring clinical trial NCT05868122?
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 NCT05868122's enrollment target sits among peer trials
143 1559th of 2000 higher than 442 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01861106 · 144 participants · Phase 2
Allogeneic Hematopoietic Stem Cell Transplant for GATA2 Mutations
- NCT03482245 · 144 participants · NA
The Role of Circadian Clock Proteins in Innate and Adaptive Immunity
- NCT03504683 · 144 participants · NA
MEAL TIMING Study: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes
- NCT03905603 · 144 participants · Early Phase 1
Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI