Aphthous StomatitisPhase 3NCT05542173
Efficacy and Safety of BALI Association in the Treatment of Aphthous Ulcerations
A Phase 3 study testing BALI association in people with Aphthous Stomatitis, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of BALI association in the treatment of aphthous ulceration. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aphthous Stomatitis
- What is being tested?
- BALI association
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2024to Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
EMS
Hortolândia, São Paulo
Cassiano Ricardo O Berto, B.S., +551938877724, pesquisa.clinica@ncfarma.com.br
About this study
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
The purpose of this study is to evaluate the efficacy and safety of BALI association in the treatment of aphthous ulceration.
- Conditions
- Aphthous Stomatitis
- Being tested
- BALI association, Placebo
- Keywords
- Aphthous Stomatitis
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BALI associationDrug
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.
PlaceboDrug
Placebo. Three applications per day or more in case of pain, not exceeding six applications per day.
| Study group | Role | What they receive |
|---|---|---|
| BALI 25 + 25 + 15 | Experimental | 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. Receives: Drug: BALI association |
| PLACEBO | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 3 days
Secondary outcomes (5)
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").
Measured: 15 minutes
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").
Measured: 5 and 7 days
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".
Measured: 3, 5 and 7 days
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".
Measured: 3, 5 and 7 days
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").
Measured: 3, 5 and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphthous StomatitisStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542173
- Sponsor's protocol ID
- EMS0322 - BALI
- Status last verified
- Feb 2024
- First submitted
- 13 Sep 2022
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05542173
- Acronym / sponsor ID
- EMS0322 - BALI
- Conditions
- Aphthous Stomatitis
- Keywords
- Aphthous Stomatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of BALI association in the treatment of aphthous ulceration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BALI 25 + 25 + 15 | Experimental | Drug: BALI associationThree 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. |
| PLACEBO | Placebo comparator | Drug: PlaceboThree 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BALI associationBALI 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 | BALI 25 + 25 + 15 |
| PlaceboPlacebo. Three applications per day or more in case of pain, not exceeding six applications per day. | Drug | PLACEBO |
Primary outcome
To assess the reduction in pain intensity after 3 days of treatment.
Time frame: 3 days
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").
5 secondary outcomes
To assess the reduction in pain intensity after the first application.
Time frame: 15 minutes
To assess the reduction in pain intensity during the treatment.
Time frame: 5 and 7 days
Percentage of participants healed during treatment.
Time frame: 3, 5 and 7 days
Percentage of participants with no pain during treatment.
Time frame: 3, 5 and 7 days
To assess the percentage change in pain intensity from baseline during treatment.
Time frame: 3, 5 and 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BALI association in people with Aphthous Stomatitis, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the reduction in pain intensity after 3 days of treatment. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.