NCT04647435

Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction

National, Multicentre, Randomized, Double-blind, Triple-dummy Active-Controled Phase III Clinical Trial to Evaluate the Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 396 (actual)
• Sponsor: Apsen Farmaceutica S.A. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy of APSCTC compared to two active drugs in acute pain relief.

Conditions

• Postsurgical Pain
• Third Molar Extraction

Interventions

Type	Name	Description
DRUG	APSCTC	APSCTC + Toragesic® placebo + Tramal® placebo
DRUG	Toragesic®	APSCTC placebo + Toragesic® + Tramal® placebo
DRUG	Tramal®	APSCTC placebo + Toragesic® placebo + Tramal®

Timeline

• Start date: 2023-05-13
• Primary completion: 2024-10-04
• Completion: 2024-10-04
• First posted: 2020-12-01
• Last updated: 2025-02-07

Locations

1 site across 1 country: Brazil