Trials / Withdrawn
WithdrawnNCT05845008
A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain
An Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety of a Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents 12 to Less Than 17 Years of Age With Orthodontic Pain
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI) · Industry
- Sex
- All
- Age
- 12 Years – 16 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety of a fixed combination of acetaminophen/naproxen sodium when administered as multiple doses over a period of up to 10 days in adolescents 12 to below 17 years of age with post-procedure orthodontic pain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acetaminophen/Naproxen Sodium Fixed Combination | Acetaminophen/naproxen sodium fixed combination tablets, oral. |
Timeline
- Start date
- 2024-01-15
- Primary completion
- 2024-07-15
- Completion
- 2024-07-26
- First posted
- 2023-05-06
- Last updated
- 2024-03-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05845008. Inclusion in this directory is not an endorsement.