Overview

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

Status:
Recruiting
Trial end date:
2021-10-18
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Apsen Farmaceutica S.A.
Treatments:
Amitriptyline
Cyclobenzaprine
Etodolac
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.