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

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A clinical, multicenter, randomized, parallel-group, double-blind, double-dummy, comparative study of non-inferiority.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Ibuprofen; Oxycodone

Criteria

Inclusion Criteria:

1. Aged between 16 and 35 years old (inclusive).

2. Presence of impacted third lower molar with surgical removal indicated (diagnosed via panoramic x-ray within six [6] months before inclusion in the study), at vertical, mesioangular or horizontal position as per the Winter's classification, provided that it belongs to the following Pell & Gregory's classes.

3. Maximum surgery duration of 40 minutes, counted from the initial incision to the impacted third molar extraction.

4. Moderate to intense postoperative pain (≥ 40 mm at a VAS of 0-100 mm) up to four (4) hours after the end of the surgery (counted from the end of the suture).

5. Informed Consent Form (ICF) and Informed Assent Form (IAF) signature, when applicable, before performing any study procedure

Exclusion Criteria:

1. Known hypersensitivity to oxycodone or other opioid agents.

2. Known hypersensitivity to ibuprofen, acetylsalicylic acid (ASA), or any other non-steroidal anti-inflammatory drug (NSAID).

3. Known hypersensitivity to paracetamol or to any component of the Tylex® formulation;

4. History of bronchospasm or other anaphylactoid reactions (e.g.: hives, rhinitis, angioedema) associated with the use of analgesics, such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen;

5. Abuse of illegal drugs, including alcoholism; emotional instability and/or previous attempt of suicide;

6. Pregnancy or breastfeeding.

7. Women of childbearing potential who do not agree to use a known effective birth control method, unless the participants are surgically sterile or state they are expressly free of the risk of getting pregnant for not having sexual intercourse or for having sexual intercourse with no reproductive potential.

8. Known hepatic or renal failure.

9. Participation in a clinical research protocol within the past 12 months, unless the investigator considers that the participation in the study could result in a direct benefit to the subject.

10. Presence of any condition that, in the investigator's opinion, would make the subject ineligible to participate in the study.