Pain, Acute
Conditions
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.
Interventions
Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg
DRUGEtodolac
Individual drug
DRUGCyclobenzaprine
Individual drug
Sponsors
Apsen Farmaceutica S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Superiority of the Fixed Dose Combination versus Isolated active substances | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual response rate | 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 |
| Edema | 4 hours | Absence of edema after 4 hours of drug administration and at the end of treatment |
| Mandibula constriction | 4 hours | Absence of mandibular constriction after 4 hours of drug administration and at the end of treatment |
| Use of rescue medication | 3 days | Proportion of participants requiring the use of rescue medication over the 3 days of treatment in each treatment group |
Countries
Brazil
Outcome results
None listed