A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain

Orthodontic Pain Clinical Trial

Official title:
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Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Orthodontic Pain

Clinical Trial Details

NCT number	NCT05845008
Study type	Interventional
Source	Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status	Withdrawn
Phase	Phase 3
Start date	January 15, 2024
Completion date	July 26, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05844995` - A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain	Phase 1
Recruiting	`NCT03816943` - The Influence of Communication After Placement of Orthodontic Fixed Appliances on Pain, Anxiety and Oral Health Quality of Life Among Malaysian Population	N/A
Recruiting	`NCT04836234` - Chewing Gum Effect in Reducing Orthodontic Pain After Separator and Initial Arch Wire Placement	N/A
Completed	`NCT00484744` - Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement	Phase 4
Recruiting	`NCT03755622` - Comparing Clinical Application of Innovatedly Made Transpalatal Arch (TPA) From 3D Reconstructed Model and Conventionally Made TPA	N/A
Enrolling by invitation	`NCT05777122` - Pain Reduction After Separators Placement	Phase 2
Recruiting	`NCT04834466` - Factors Associated With Pain Level Experience in Orthodontic Treatment