Back to resultsEfficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations
Primary Purpose
Aphthous Stomatitis
Status
Not yet recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
BALI association
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Aphthous Stomatitis focused on measuring Aphthous Stomatitis
Eligibility Criteria
Inclusion Criteria:
- Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
- Age greater than or equal to 12 years;
- Minor recurrent aphthous ulceration with onset of symptoms within 48 hours;
- Moderate to severe baseline pain, with VAS ≥ 4 (EVA scale).
Exclusion Criteria:
- Any clinical findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- Participants diagnosed with: Behcet's disease, rheumatoid arthritis, systemic lupus erythematosus, reactive arthritis, Reiter's syndrome, Crohn's disease, ulcerative colitis);
- Participants with diseases that affect healing (e.g. diabetes);
- Immunocompromised participants;
- Participants with aphthous herpetiform ulceration or major aphthous ulceration;
- Participants using medication to treat oral ulcerations (systemic or local);
- Participants who used analgesics or anti-inflammatory drugs in the 6 hours prior to the beginning of the study;
- Participants who used systemic antibiotics in the 2 weeks prior to the beginning of the study;
- Participants using medications that can confuse pain assessment (psychotropics, antidepressants and sedative-hypnotics), except when on a stable dose for at least 30 days prior to the screening visit, and the dose cannot be changed during the clinical trial;
- Participants with current smoking habits.
- Participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception;
- Known hypersensitivity to the formula components used during the clinical trial;
- Participants with current or medical history of cancer in the last 5 years;
- Participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.
Sites / Locations
- EMS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BALI 25 + 25 + 15
PLACEBO
Arm Description
Three applications per day or more in case of pain, not exceeding six applications per day. The number of drops varies according to the ulcer diameter: 1 to 3 mm: 1 drop; 3 to 6 mm: 2 drops; greater than 6 mm: 3 drops.
Three applications per day or more in case of pain, not exceeding six applications per day. The number of drops varies according to the ulcer diameter: 1 to 3 mm: 1 drop; 3 to 6 mm: 2 drops; greater than 6 mm: 3 drops.
Outcomes
Primary Outcome Measures
To assess the reduction in pain intensity after 3 days of treatment.
Difference in pain intensity after 3 days of treatment compared to baseline. Pain intensity will be evaluated by the Visual Analogue Scale (VAS). The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").
Secondary Outcome Measures
To assess the reduction in pain intensity after the first application.
Difference in pain intensity 15 minutes after the first application of the medication compared to baseline, measured by the VAS scale. The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").
To assess the reduction in pain intensity during the treatment.
Difference in pain intensity after 5 and 7 days of treatment compared to baseline, measured by the VAS scale. The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").
Percentage of participants healed during treatment.
Percentage of participants healed after 3, 5, and 7 days of treatment, defined as ulcer diameter = 0 mm and pain intensity = 0, measured by the Likert scale. Likert scale is a five point scale: 0 = no pain and 4 = pain as bad as it could possibly be".
Percentage of participants with no pain during treatment.
Percentage of participants with no pain after 3, 5, and 7 days of treatment, measured by the Likert scale. Likert scale is a five point scale: 0 = "no pain" and 4 = "pain as bad as it could possibly be".
To assess the percentage change in pain intensity from baseline during treatment.
Pain intensity will be evaluated by the VAS scale.The following calculations will be performed: ((D3, D5 or D7 - V0) / baseline) ×100%. The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05542173
Brief Title
Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations
Official Title
National, Multicenter, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of BALI association in the treatment of aphthous ulceration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphthous Stomatitis
Keywords
Aphthous Stomatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
232 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BALI 25 + 25 + 15
Arm Type
Experimental
Arm Description
Three applications per day or more in case of pain, not exceeding six applications per day. The number of drops varies according to the ulcer diameter: 1 to 3 mm: 1 drop; 3 to 6 mm: 2 drops; greater than 6 mm: 3 drops.
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
Three applications per day or more in case of pain, not exceeding six applications per day. The number of drops varies according to the ulcer diameter: 1 to 3 mm: 1 drop; 3 to 6 mm: 2 drops; greater than 6 mm: 3 drops.
Intervention Type
Drug
Intervention Name(s)
BALI association
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo. Three applications per day or more in case of pain, not exceeding six applications per day.
Primary Outcome Measure Information:
Title
To assess the reduction in pain intensity after 3 days of treatment.
Description
Difference in pain intensity after 3 days of treatment compared to baseline. Pain intensity will be evaluated by the Visual Analogue Scale (VAS). The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").
Time Frame
3 days
Secondary Outcome Measure Information:
Title
To assess the reduction in pain intensity after the first application.
Description
Difference in pain intensity 15 minutes after the first application of the medication compared to baseline, measured by the VAS scale. The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").
Time Frame
15 minutes
Title
To assess the reduction in pain intensity during the treatment.
Description
Difference in pain intensity after 5 and 7 days of treatment compared to baseline, measured by the VAS scale. The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").
Time Frame
5 and 7 days
Title
Percentage of participants healed during treatment.
Description
Percentage of participants healed after 3, 5, and 7 days of treatment, defined as ulcer diameter = 0 mm and pain intensity = 0, measured by the Likert scale. Likert scale is a five point scale: 0 = no pain and 4 = pain as bad as it could possibly be".
Time Frame
3, 5 and 7 days
Title
Percentage of participants with no pain during treatment.
Description
Percentage of participants with no pain after 3, 5, and 7 days of treatment, measured by the Likert scale. Likert scale is a five point scale: 0 = "no pain" and 4 = "pain as bad as it could possibly be".
Time Frame
3, 5 and 7 days
Title
To assess the percentage change in pain intensity from baseline during treatment.
Description
Pain intensity will be evaluated by the VAS scale.The following calculations will be performed: ((D3, D5 or D7 - V0) / baseline) ×100%. The VAS consists of a 10 cm line, with two end points representing 0 ("no pain") and 10 (pain as bad as it could possibly be").
Time Frame
3, 5 and 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
Age greater than or equal to 12 years;
Minor recurrent aphthous ulceration with onset of symptoms within 48 hours;
Moderate to severe baseline pain, with VAS ≥ 4 (EVA scale).
Exclusion Criteria:
Any clinical findings that, in the judgment of the investigator, may interfere with the safety of research participants;
Participants diagnosed with: Behcet's disease, rheumatoid arthritis, systemic lupus erythematosus, reactive arthritis, Reiter's syndrome, Crohn's disease, ulcerative colitis);
Participants with diseases that affect healing (e.g. diabetes);
Immunocompromised participants;
Participants with aphthous herpetiform ulceration or major aphthous ulceration;
Participants using medication to treat oral ulcerations (systemic or local);
Participants who used analgesics or anti-inflammatory drugs in the 6 hours prior to the beginning of the study;
Participants who used systemic antibiotics in the 2 weeks prior to the beginning of the study;
Participants using medications that can confuse pain assessment (psychotropics, antidepressants and sedative-hypnotics), except when on a stable dose for at least 30 days prior to the screening visit, and the dose cannot be changed during the clinical trial;
Participants with current smoking habits.
Participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception;
Known hypersensitivity to the formula components used during the clinical trial;
Participants with current or medical history of cancer in the last 5 years;
Participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.
Facility Information:
Facility Name
EMS
City
Hortolândia
State/Province
São Paulo
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassiano Ricardo O Berto, B.S.
Phone
+551938877724
Email
pesquisa.clinica@ncfarma.com.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations
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