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Clinical Trial Summary

The purpose of this study is to investigate the population pharmacokinetics of acetaminophen and naproxen from a novel acetaminophen /naproxen sodium fixed combination tablet in adolescents 12 to less than (<) 17 years of age with post-procedure orthodontic pain and to describe the effect of subject-specific covariates, including age and body weight, on inter-subject variability in acetaminophen and naproxen pharmacokinetics in adolescents 12 to <17 years of age with post-procedure orthodontic pain.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05844995
Study type Interventional
Source Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status Completed
Phase Phase 1
Start date September 13, 2023
Completion date February 14, 2024

See also
  Status Clinical Trial Phase
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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
Withdrawn NCT05845008 - A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain Phase 3
Enrolling by invitation NCT05777122 - Pain Reduction After Separators Placement Phase 2
Recruiting NCT04834466 - Factors Associated With Pain Level Experience in Orthodontic Treatment