NCT06237231

Efficacy and Safety of DIT112 in the Treatment of Moderate to Severe Pain After Dental Surgery for the Extraction of Impacted Third Molars

Phase III, Multicenter, Double-blind, Triple-dummy, Randomized, Parallel Clinical Trial to Evaluate the Efficacy and Safety of DIT112 in the Treatment of Moderate to Severe Pain After Dental Surgery for the Extraction of Impacted Third Molars

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: EMS · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of DIT112 in adolescents and adults with acute pain after dental surgery for the extraction of impacted third molars.

Conditions

• Moderate Pain
• Severe Pain

Interventions

Type	Name	Description
DRUG	DIT112	DIT112 tablet
DRUG	DIPYRONE	Dipyrone tablet 1.000mg
DRUG	TRAMADOL	Tramadol tablet 50mg
DRUG	DIT112 Placebo	DIT112 placebo tablet
DRUG	Dipyrone Placebo	Dipyrone placebo tablet
DRUG	Tramadol Placebo	Tramadol placebo capsule

Timeline

• Start date: 2025-02-15
• Primary completion: 2025-03-15
• Completion: 2027-04-10
• First posted: 2024-02-01
• Last updated: 2024-02-20