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Completed NCT05081102

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

Conditions: Pain

Sex: All
Ages: 16 Years – 35 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 288
Sponsor: Eurofarma Laboratorios S.A.

Location: Eurofarma Laboratorios S.A São Paulo São Paulo

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) .

Eligibility 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05081102). StuddyBuddy aggregates publicly available trial information.