NCT05772338

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of BNP105 in the treatment of recurrent aphthous stomatitis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

January 22, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

March 6, 2023

Last Update Submit

February 15, 2024

Conditions

Aphthous Stomatitis

Keywords

Aphthous Stomatitis

Outcome Measures

Primary Outcomes (1)

  • To assess the change in pain intensity after the first application.

    Difference in pain intensity 3 and 10 minutes after the first application of the medication compared to baseline, measured by the VAS scale. The VAS consists of a 100 mm line, with two end points representing 0 ("no pain") and 100 (Worst Possible Pain").

    3 and 10 minutes

Secondary Outcomes (7)

  • To assess the change in pain intensity after 3 days of treatment.

    3 days

  • To assess the pain intensity daily after breakfast, lunch and dinner.

    7 days

  • To assess the pain intensity daily at night.

    7 days

  • To assess the oral health-related quality of life

    7 days

  • Percentage of participants healed after 3 days of treatment.

    3 days

  • +2 more secondary outcomes

Study Arms (2)

BNP105 (25 + 25 + 15)

EXPERIMENTAL

Up to 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.

Drug: BNP105 (25 + 25 + 15)

Placebo

PLACEBO COMPARATOR

Up to 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.

Other: Placebo

Interventions

BNP105 (25 + 25 + 15)DRUG

BNP105 oral suspension, 25 mg + 25 mg + 15 mg, oral. Up to six applications per day.

BNP105 (25 + 25 + 15)
PlaceboOTHER

Placebo. Up to six applications per day.

Placebo

Eligibility Criteria

Age12 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • One minor recurrent aphthous stomatitis with onset of symptoms within 48 hours;
  • Moderate to severe baseline pain, with VAS ≥ 60 mm (EVA scale 0-100 mm).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

EMS

Hortolândia, São Paulo, 13183-250, Brazil

NOT YET RECRUITING

Cecip Jau - Centro de Estudos Clinicos Do Interior Paulista Ltda

Jaú, São Paulo, 17210-190, Brazil

RECRUITING

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

StomatitisMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 16, 2023

Study Start

January 22, 2024

Primary Completion

January 1, 2025

Study Completion

April 1, 2025

Last Updated

February 20, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)