Trials / Completed
CompletedNCT05868122
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Multidose Clinical Trial to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI) · Industry
- Sex
- All
- Age
- 16 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acetaminophen/Naproxen Sodium Fixed Combination | Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally. |
| DRUG | Placebo | Placebo will be administered orally. |
Timeline
- Start date
- 2023-09-07
- Primary completion
- 2024-05-30
- Completion
- 2024-05-30
- First posted
- 2023-05-22
- Last updated
- 2025-05-15
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05868122. Inclusion in this directory is not an endorsement.