Phase III Efficacy and Tolerability Trial of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus Isolated Active Substances in Pain Control After Impacted Third Molar Extraction

Phase 3

Terminated

• Conditions: Pain, Acute
• Interventions: Drug: Etodolac; Drug: Fixed Dose Combination; Drug: Cyclobenzaprine

• Registration Number: NCT03127592
• Lead Sponsor: Apsen Farmaceutica S.A.

Brief Summary

This Phase III study will compare the efficacy and tolerability of a Fixed Dose Combination of Etodolac + Cyclobenzaprine versus the isolated drugs in postoperative pain control after impacted third molar extraction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Study Start: 2020-10-05
• Primary Completion: 2022-07-26
• Study Completion: 2022-07-26
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Healthy research participants of both sexes (male and female non-pregnant), aged 18 years or over, underwent impacted third molar extraction surgery

Exclusion Criteria

• Presence of any event and / or pathology at the site of interest that may interfere with and contraindicate the performance of the surgical procedure at the discretion of the Investigator, including periodontitis, odontogenic tumors or cysts (associated or not with the third molar), trauma, presence of Inflammation and / or infection;
• Present or past history of any cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematological event;
• Previous diagnosis of alcohol and drug abuse defined by DSM-V;
• Current or past history (for less than 12 months) of smoking;
• Use of illicit drugs;
• History of bleeding / bleeding or coagulation disorders, gastric ulcer and / or active peptic hemorrhage;
• Any finding of clinical (clinical / physical), laboratory or cardiac evaluation (ECG) observation that is interpreted by the investigating physician as a risk to the participant;
• Use of drugs that potentially interfere with the kinetics / dynamics of acetaminophen or any other medicinal product considered clinically significant by the Investigator;
• Known hypersensitivity to the active principles used during the study (etodolac and cyclobenzaprine);
• Women in gestation or breastfeeding, as well as women who present a positive pregnancy test (β - hCG) during the study screening / selection period;
• Professionals directly involved in the realization of the present study and their relatives;
• Participant of the research that has participated in clinical study protocols in the last 12 (twelve) months, unless the Investigator deems that there may be direct benefit to it.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	Etodolac	1 active treatment (Etodolac) + 2 placebos
Group 1	Fixed Dose Combination	1 active treatment (Fixed Dose Combination) + 2 placebos
Group 2	Cyclobenzaprine	1 active treatment (Cyclobenzaprine) + 2 placebos

Primary Outcome Measures

Name	Time	Method
Superiority of the Fixed Dose Combination versus Isolated active substances	4 hours	The Primary outcome will be accessed by the individual response rate in relation to the pain intensity calculated by the Visual Analogic Scale (VAS) scale performed after 4 hours of administration of the first dose of medicines

Secondary Outcome Measures

Name	Time	Method
Mandibula constriction	4 hours	Absence of mandibular constriction after 4 hours of drug administration and at the end of treatment
Individual response rate	6h, 12h, 24h, 48h and 72h	Individual response rate in relation to the evaluation of pain intensity calculated through the Visual Analogic Scale (VAS) measure in times 6h, 12h, 24h, 48h and 72h
Edema	4 hours	Absence of edema after 4 hours of drug administration and at the end of treatment
Use of rescue medication	3 days	Proportion of participants requiring the use of rescue medication over the 3 days of treatment in each treatment group

Trial Locations

Locations (1)

Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.; 🇧🇷 Valinhos, São Paulo, Brazil