NCT05081102

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 16 Years – 35 Years
• Healthy volunteers: Accepted

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) .

Detailed description

Patients aged between 16 and 35 years with indication for surgical removal of impacted lower third molar will be randomized at a 1:1 ratio to receive FDC oxycodone 5 mg/ibuprofen 400 mg from Eurofarma Laboratórios SA (experimental drug) or FDC codeine 30 mg/paracetamol 500 mg (Tylex® - Janssen-Cilag Farmacêutica Ltda.) as tablets, for up to three (03) days. Participants whose surgery lasts no more than 40 minutes (starting from the initial incision to the extraction of impacted third molar) and who experience post-surgical pain that is moderate to intense in intensity up to four (04) hours after the surgery ends will be randomized. The first administration of the study treatment will be performed at the clinical investigation site when post-surgical pain reaches moderate/intense intensity (≥ 40 mm on a 0-100 mm Visual Analogue Scale \[VAS\]). Participants will be instructed to, from then on, use the study treatment as needed for pain relief, observing a minimum interval of six (06) hours between two intakes, for up to three (03) days (72 hours after the initial dose). Subjects who meet all of the eligibility criteria will be randomized to one of the following treatment groups: Group 1: FDC oxycodone 5 mg/ibuprofen 400 mg from Eurofarma Laboratórios SA (experimental drug) - Participants randomized to this group will receive one (01) tablet of the experimental drug + one (01) tablet of Tylex® placebo when post-surgical pain intensity reaches moderate to intense intensity (≥ 40 mm on a 0-100 mm VAS). Group 2: Tylex® (codeine 30 mg/paracetamol 500 mg) - Participants randomized to this group will receive one (01) Tylex® tablet (codeine 30 mg/paracetamol 500 mg) + one (01) tablet of FCD placebo when post-surgical pain intensity reaches moderate to intense intensity (≥ 40 mm on a 0-100 mm VAS). The subjects will be allowed to use the rescue medication if necessary: Paracetamol 500 mg (Tylenol® 500 mg). All subjects must have three (3) on-site visits at the research site. Three (3) phone calls will take place between the on-site visits: Screening visit (Vs), randomization visit (Vr), first phone call (CT1), second phone call (CT2), third phone call (CT3), final visit (Vf). The period for enrolling participants in the study will begin after the necessary ethical and regulatory approvals and will have an estimated duration of up to 12 months. The approximate duration of the study will be 16 ± 2 days for each participant. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Conditions

• Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-27
• Primary completion: 2024-05-28
• Completion: 2024-09-30
• First posted: 2021-10-18
• Last updated: 2025-02-14

Locations

1 site across 1 country: Brazil