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 (FDCETCB-III)

February 7, 2023 updated by: Apsen Farmaceutica S.A.

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • São Paulo
      • Valinhos, São Paulo, Brazil, 13271-130
        • Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1
1 active treatment (Fixed Dose Combination) + 2 placebos
Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg
ACTIVE_COMPARATOR: Group 2
1 active treatment (Cyclobenzaprine) + 2 placebos
Individual drug
Other Names:
  • Miosan
ACTIVE_COMPARATOR: Group 3
1 active treatment (Etodolac) + 2 placebos
Individual drug
Other Names:
  • Flancox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superiority of the Fixed Dose Combination versus Isolated active substances
Time Frame: 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
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual response rate
Time Frame: 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
6h, 12h, 24h, 48h and 72h
Edema
Time Frame: 4 hours
Absence of edema after 4 hours of drug administration and at the end of treatment
4 hours
Mandibula constriction
Time Frame: 4 hours
Absence of mandibular constriction after 4 hours of drug administration and at the end of treatment
4 hours
Use of rescue medication
Time Frame: 3 days
Proportion of participants requiring the use of rescue medication over the 3 days of treatment in each treatment group
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 5, 2020

Primary Completion (ACTUAL)

July 26, 2022

Study Completion (ACTUAL)

July 26, 2022

Study Registration Dates

First Submitted

April 17, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (ACTUAL)

April 25, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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