MedTrace Logo

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

NCT05542173 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2024-02-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • EMS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

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 NCT05542173 on ClinicalTrials.gov