NCT04972292

Fixed Dose Combination of COdeine + DIpyrone to Mitigate Moderate to Intense Pain Post-impacted Third Lower Molar Extraction

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: 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: Not 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

Subjects aged between 16 and 35 years old, with indicated surgical removal of impacted third lower molar, will be randomized at a 1:1 ratio to receive the FDC of codeine 30 mg/dipyrone 500 mg from Eurofarma Laboratórios SA (experimental drug) or the FDC of codeine 30 mg/paracetamol 500 mg (Tylex® - Janssen-Cilag Farmacêutica Ltda) as tablets for up to three (3) days. Subjects whose surgery lasts no more than 40 minutes and showing moderate to intense postoperative pain up to four (4) hours after surgery will be randomized. The first study drug administration will take place at the clinical investigation site when the postsurgical pain becomes moderate/intense (≥ 40 mm at a visual analogue scale \[VAS\] of 0-100 mm). Then, subjects will be instructed to use the study treatment whenever it is necessary for pain relief, respecting a minimal interval of six (6) hours between two administrations, for up to three (3) days (72 hours after the initial dose). Subjects will evaluate the pain relief using a 5-point categorical scale (0 = no relief, 1 = little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief) in 1-hour intervals (1, 2, 3, 4, 5 and 6h). The sum of the relief scores over 6 hours determines the TOTPAR6 Subjects who meet all of the eligibility criteria will be randomized to one of the following treatment groups: Group 1: FDC of codeine 30 mg/dipyrone 500 mg from Eurofarma Laboratórios SA (experimental drug) - Subjects randomized to this group will receive one (1) experimental drug tablet + one (1) Tylex® placebo tablet when the postoperative pain becomes moderate to intense (≥ 40 mm at a VAS of 0-100 mm). Group 2: Tylex® (codeine 30 mg/paracetamol 500 mg) - Subjects randomized to this group will receive one (1) Tylex® tablet (codeine 30 mg/paracetamol 500 mg) + one (1) FDC placebo tablet when the postoperative pain becomes moderate to intense (≥ 40 mm at a VAS of 0-100 mm). 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 including subjects in the study will start after the required ethical and regulatory approvals and its estimated duration will be of up to 12 months. The approximate study duration will be of 9 ± 2 days for each subject. ⚠️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 codeine 30 mg/dipyrone 500 mg	Group 1: receive one (1) experimental drug tablet (FCD of codeine 30mg/dipyrone 500mg) + one (1) Tylex® placebo.
DRUG	Tylex	Group 2: receive one (1) Tylex® tablet (codeine 30 mg/paracetamol 500 mg) + one (1) FDC placebo tablet

Timeline

• Start date: 2023-11-08
• Primary completion: 2024-05-28
• Completion: 2024-05-30
• First posted: 2021-07-22
• Last updated: 2025-02-14

Locations

2 sites across 1 country: Brazil