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

Pain, Acute Clinical Trial

— FDCETCB-III  

Official title:

Phase III Randomized, Unicentric, Double-masked, Parallel Trial for the Efficacy and Tolerability of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus the Isolated Active Substances (Flancox® 400 mg And Miosan® 10 mg) in Postoperative Pain Control After Impacted Third Molar Extraction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03127592
• Other study ID #: ETCAPS0317OR-III
• Status: Terminated
• Phase: Phase 3
• Start date: October 5, 2020
• Est. completion date: July 26, 2022

Study information

• Verified date: February 2023
• Source: Apsen Farmaceutica S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 140
• Est. completion date: July 26, 2022
• Est. primary completion date: July 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 (ß - 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.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

Drug:
• Fixed Dose Combination
Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg
• Etodolac
Individual drug
• Cyclobenzaprine
Individual drug

Locations

Country	Name	City	State
Brazil	Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.	Valinhos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Apsen Farmaceutica S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superiority of the Fixed Dose Combination versus Isolated active substances	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	4 hours
Secondary	Individual response rate	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	6h, 12h, 24h, 48h and 72h
Secondary	Edema	Absence of edema after 4 hours of drug administration and at the end of treatment	4 hours
Secondary	Mandibula constriction	Absence of mandibular constriction after 4 hours of drug administration and at the end of treatment	4 hours
Secondary	Use of rescue medication	Proportion of participants requiring the use of rescue medication over the 3 days of treatment in each treatment group	3 days