FDCETCB-III: 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

• Sponsor: Apsen Farmaceutica S.A. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03127592
• Collaborator: (none)
• Enrollment: 465
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 26.4
• Patients Per Site Per Month: 17.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Acute	Drug: Fixed Dose Combination; Drug: Etodolac; Drug: Cyclobenzaprine	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 465 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 5, 2020
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Dec 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 1 active treatment (Fixed Dose Combination) + 2 placebos	Drug: Fixed Dose Combination; Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg
Active Comparator: Group 2 1 active treatment (Cyclobenzaprine) + 2 placebos	Drug: Cyclobenzaprine; Individual drug; Other Names: Miosan
Active Comparator: Group 3 1 active treatment (Etodolac) + 2 placebos	Drug: Etodolac; Individual drug; Other Names: Flancox

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Edema [4 hours]

   Absence of edema after 4 hours of drug administration and at the end of treatment

3. Mandibula constriction [4 hours]

   Absence of mandibular constriction after 4 hours of drug administration and at the end of treatment

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.	Valinhos	São Paulo	Brazil	13271-130

Sponsors and Collaborators

• Apsen Farmaceutica S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Apsen Farmaceutica S.A.
• ClinicalTrials.gov Identifier: NCT03127592
• Other Study ID Numbers: ETCAPS0317OR-III
• First Posted: Apr 25, 2017
• Last Update Posted: Apr 20, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Pain; Etodolac; Cyclobenzaprine

Study Results

No Results Posted as of Apr 20, 2022