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COMPLETED
NCT05081102
PHASE3

Fixed-dose Combination of Oxycodone [OXIcodona] + IbuproFEN in Pain Relief After Third Molar Extraction

Sponsor: Eurofarma Laboratorios S.A.

View on ClinicalTrials.gov

Summary

A clinical, multicenter, randomized, parallel-group, double-blind, double-dummy, comparative study of non-inferiority. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil) .

Official title: A Clinical, Multicenter, Randomized, Parallel-group, Double-dummy, Comparative Study of Non-inferiority of the Fixed-dose Combination of Oxycodone 5 mg/Ibuprofen 400 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

Key Details

Gender

All

Age Range

16 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

288

Start Date

2024-03-27

Completion Date

2024-09-30

Last Updated

2026-09-25

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

FDC of oxycodone 5 mg/ibuprofen 400 mg

receive one (1) experimental drug tablet (FCD of oxycodone 5mg/ibuprofen 400mg) + one (1) Tylex® placebo.

DRUG

Tylex

receive one (1) Tylex® tablet (codeine 30 mg/paracetamol 500 mg) + one (1) FDC placebo tablet

Locations (1)

Eurofarma Laboratorios S.A

São Paulo, São Paulo, Brazil