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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Apsen Farmaceutica S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain, Acute

Interventions

Type	Name	Description
DRUG	Fixed Dose Combination	Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg
DRUG	Etodolac	Individual drug
DRUG	Cyclobenzaprine	Individual drug

Timeline

• Start date: 2020-10-05
• Primary completion: 2022-07-26
• Completion: 2022-07-26
• First posted: 2017-04-25
• Last updated: 2023-02-09

Locations

1 site across 1 country: Brazil