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

NCT ID: NCT03127592

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-05
• Study Completion Date: 2022-07-26

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.

Conditions

Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

1 active treatment (Fixed Dose Combination) + 2 placebos

Group Type: EXPERIMENTAL

Fixed Dose Combination

Intervention Type: DRUG

Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg

Group 2

1 active treatment (Cyclobenzaprine) + 2 placebos

Group Type: ACTIVE_COMPARATOR

Cyclobenzaprine

Intervention Type: DRUG

Individual drug

Group 3

1 active treatment (Etodolac) + 2 placebos

Group Type: ACTIVE_COMPARATOR

Etodolac

Intervention Type: DRUG

Individual drug

Interventions

Fixed Dose Combination

Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg

Intervention Type: DRUG

Etodolac

Individual drug

Intervention Type: DRUG

Cyclobenzaprine

Individual drug

Intervention Type: DRUG

Other Intervention Names

Flancox; Miosan

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Apsen Farmaceutica S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.

Valinhos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

ETCAPS0317OR-III

Identifier Type: -

Identifier Source: org_study_id