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Phase III Randomized, Unicentric, Double-masked, Parallel Trial for the Efficacy and Tolerability of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus the Isolated Active Substances (Flancox 400 mg And Miosan 10 mg) in Postoperative Pain Control After Impacted Third Molar Extraction

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Trial Profile

Phase III Randomized, Unicentric, Double-masked, Parallel Trial for the Efficacy and Tolerability of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus the Isolated Active Substances (Flancox 400 mg And Miosan 10 mg) in Postoperative Pain Control After Impacted Third Molar Extraction

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2023

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At a glance

  • Drugs Cyclobenzaprine/etodolac (Primary) ; Cyclobenzaprine; Etodolac
  • Indications Postoperative pain
  • Focus Therapeutic Use
  • Acronyms FDCETCB-III
  • Sponsors Apsen Farmaceutica
  • Most Recent Events

    • 07 Feb 2023 Status changed from recruiting to discontinued.
    • 19 Apr 2022 Planned End Date changed from 18 Oct 2021 to 18 Dec 2022.
    • 19 Apr 2022 Planned primary completion date changed from 30 Jun 2021 to 30 Sep 2022.

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