Clinical trial NCT03127592: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain, Acute
Lead sponsor: Apsen Farmaceutica S.A.
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Superiority of the Fixed Dose Combination versus Isolated active substances
timeFrame: 4 hours
Secondary outcomes:
measure: Individual response rate
timeFrame: 6h, 12h, 24h, 48h and 72h
measure: Edema
timeFrame: 4 hours
measure: Mandibula constriction
timeFrame: 4 hours
measure: Use of rescue medication
timeFrame: 3 days
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.
state: São Paulo
Study officials:
References: