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TERMINATED
NCT03127592
PHASE3

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.

View on ClinicalTrials.gov

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

DRUG

Fixed Dose Combination

Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg

DRUG

Etodolac

Individual drug

DRUG

Cyclobenzaprine

Individual drug

Locations (1)

Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.

Valinhos, São Paulo, Brazil