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

NCT05081102 | Completed Phase 3

• 1 other identifier: EF-176
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief 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) .

Conditions

Pain

Keywords

postoperative; third lower molar extraction

Outcome Measures

Primary Outcomes (1)

• sum of pain relief scores over 6 hours (TOTPAR6)

  After the administration of the first dose of study treatment, participants will assess pain relief using the 5-point categorical scale (0 = no relief, 1 = little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief) in one-hour intervals (1, 2, 3, 4, 5, and 6 h). The sum of pain relief scores within 6 hours determines TOTPAR6, which ranges from 0 to 24, and the higher the value, the greater the pain relief.

  6 hours

Secondary Outcomes (1)

• Sum of pain relief scores over four (4) hours (TOTPAR4)

  4 hours

Study Arms (2)

Group 1: FDC oxycodone 5 mg/ibuprofen 400 mg from Eurofarma Laboratórios SA (experimental drug)

EXPERIMENTAL

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). Participants will be instructed to, from then on, use this same treatment whenever needed for pain relief, observing a minimum interval of six (06) hours between two intakes, for up to 3 days (72 hours after the initial dose).

Drug: FDC of oxycodone 5 mg/ibuprofen 400 mg

Group 2: Tylex® (codeine 30 mg/paracetamol 500 mg)

ACTIVE COMPARATOR

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). Participants will be instructed to, from then on, use this same treatment whenever needed for pain relief, observing a minimum interval of six (06) hours between two intakes, for up to 3 days (72 hours after the initial dose).

Drug: Tylex

Interventions

FDC of oxycodone 5 mg/ibuprofen 400 mg DRUG

receive one (1) experimental drug tablet (FCD of oxycodone 5mg/ibuprofen 400mg) + one (1) Tylex® placebo.

Group 1: FDC oxycodone 5 mg/ibuprofen 400 mg from Eurofarma Laboratórios SA (experimental drug)

Tylex DRUG

receive one (1) Tylex® tablet (codeine 30 mg/paracetamol 500 mg) + one (1) FDC placebo tablet

Group 2: Tylex® (codeine 30 mg/paracetamol 500 mg)

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged between 16 and 35 years old (inclusive).
• Maximum surgery duration of 40 minutes, counted from the initial incision to the impacted third molar extraction.
• 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).
• Informed Consent Form (ICF) and Informed Assent Form (IAF) signature, when applicable, before performing any study procedure

You may not qualify if:

• Known hypersensitivity to oxycodone or other opioid agents.
• Known hypersensitivity to ibuprofen, acetylsalicylic acid (ASA), or any other non-steroidal anti-inflammatory drug (NSAID).
• Known hypersensitivity to paracetamol or to any component of the Tylex® formulation;
• 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;
• Abuse of illegal drugs, including alcoholism; emotional instability and/or previous attempt of suicide;
• Pregnancy or breastfeeding.
• 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.
• Known hepatic or renal failure.
• 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.
• Presence of any condition that, in the investigator's opinion, would make the subject ineligible to participate in the study.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Eurofarma Laboratorios S.A

São Paulo, São Paulo, 06696-000, Brazil

Location

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 18, 2021
• Study Start: March 27, 2024
• Primary Completion: May 28, 2024
• Study Completion: September 30, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)