NCT05542173

Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations

National, Multicenter, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: EMS · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of BALI association in the treatment of aphthous ulceration.

Conditions

• Aphthous Stomatitis

Interventions

Type	Name	Description
DRUG	BALI association	BALI association oral suspension, 25 mg + 25 mg + 15 mg, oral. Three applications per day or more in case of pain, not exceeding six applications per day.
DRUG	Placebo	Placebo. Three applications per day or more in case of pain, not exceeding six applications per day.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2022-09-15
• Last updated: 2024-02-16

Locations

1 site across 1 country: Brazil