drugset / 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

NCT03127592 ↗

Phase 3 Terminated 140 enrolled Apsen Farmaceutica S.A.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2020-10-05
Primary completion
2022-07-26
Completion
2022-07-26

Outcome

Outcome not reported

Stopped (Enrollment): “recruitment difficulty”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Etodolac Unknown 400 mg —
Comparator cyclobenzaprine Unknown 10 mg —

Indications

No indication recorded.