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Fixed-dose Combination of Oxycodone [OXIcodona] + IbuproFEN in Pain Relief After Third Molar Extraction
Sponsor: Eurofarma Laboratorios S.A.
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
FDC of oxycodone 5 mg/ibuprofen 400 mg
receive one (1) experimental drug tablet (FCD of oxycodone 5mg/ibuprofen 400mg) + one (1) Tylex® placebo.
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