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NOT YET RECRUITING
NCT06237231
PHASE3

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

Sponsor: EMS

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

252

Start Date

2025-02-15

Completion Date

2027-04-10

Last Updated

2024-02-20

Healthy Volunteers

No

Interventions

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