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

NCT06237231 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2024-02-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • EMS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-15
Primary Completion
2025-03-15
Completion
2027-04-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06237231 on ClinicalTrials.gov