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A Clinical, Multicenter, Randomized, Parallel-group, Double-blind, Double-dummy, Comparative Study of Non-inferiority of the Fixed Dose Combination of Codeine 30 mg/Dipyrone 500 mg From Eurofarma Versus Tylex (Codeine 30 mg/Paracetamol 500 mg) in the Treatment of Moderate to Intense Pain Post-impacted Third Lower Molar Extraction

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Trial Profile

A Clinical, Multicenter, Randomized, Parallel-group, Double-blind, Double-dummy, Comparative Study of Non-inferiority of the Fixed Dose Combination of Codeine 30 mg/Dipyrone 500 mg From Eurofarma Versus Tylex (Codeine 30 mg/Paracetamol 500 mg) in the Treatment of Moderate to Intense Pain Post-impacted Third Lower Molar Extraction

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 May 2024

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At a glance

  • Drugs Codeine/dipyrone (Primary) ; Paracetamol; Paracetamol/codeine
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Acronyms CODI
  • Sponsors Eurofarma

    • Most Recent Events

    • 29 Jan 2024 Planned End Date changed from 30 Nov 2024 to 28 Feb 2025.
    • 29 Jan 2024 Planned primary completion date changed from 30 Dec 2023 to 30 Oct 2024.
    • 22 Nov 2023 Planned End Date changed from 1 Mar 2025 to 30 Nov 2024.

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