Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
Sponsor: Apsen Farmaceutica S.A.
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.
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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2020-10-05
Completion Date
2022-07-26
Last Updated
2026-09-09
Healthy Volunteers
Yes
Conditions
Interventions
Fixed Dose Combination
Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg
Etodolac
Individual drug
Cyclobenzaprine
Individual drug
Locations (1)
Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.
Valinhos, São Paulo, Brazil