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
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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