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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

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Trial Profile

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Status: Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2024

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At a glance

  • Drugs Naproxen sodium/paracetamol (Primary)
  • Indications Dental pain; Postoperative pain
  • Focus Adverse reactions; Registrational
  • Sponsors Johnson & Johnson Consumer Companies

Most Recent Events

  • 01 Mar 2024 Status changed from not yet recruiting to withdrawn prior to enrolment.
  • 18 Oct 2023 Planned End Date changed from 29 Mar 2024 to 26 Jul 2024.
  • 18 Oct 2023 Planned primary completion date changed from 22 Mar 2024 to 15 Jul 2024.

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