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)

Apsen Farmaceutica

Status and phase: Terminated; Phase 3

Conditions: Pain, Acute

Treatments: Drug: Fixed Dose Combination; Drug: Cyclobenzaprine; Drug: Etodolac

Study type: Interventional

Funder types: Industry

Identifiers

NCT03127592

ETCAPS0317OR-III

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 3 patient groups

Group 1

Experimental group

Description:

1 active treatment (Fixed Dose Combination) + 2 placebos

Treatment:

Drug: Fixed Dose Combination

Group 2

Active Comparator group

Description:

1 active treatment (Cyclobenzaprine) + 2 placebos

Treatment:

Drug: Cyclobenzaprine

Group 3

Active Comparator group

Description:

1 active treatment (Etodolac) + 2 placebos

Treatment:

Drug: Etodolac