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Efficacy and Safety of BNP105 in the Treatment of Recurrent Aphthous Stomatitis

Primary Purpose

Aphthous Stomatitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
BNP105 (25 + 25 + 15)
Placebo
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphthous Stomatitis focused on measuring Aphthous Stomatitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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; 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). 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

BNP105 (25 + 25 + 15)

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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").

Secondary Outcome Measures

To assess the change 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 100 mm line, with two end points representing 0 ("no pain") and 100 (Worst Possible Pain").
To assess the pain intensity daily after breakfast, lunch and dinner.
Pain intensity will be evaluated daily after breakfast, lunch and dinner by the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale scored from 0-10 representing 0 ("no pain") and 10 (Worst Possible Pain").
To assess the pain intensity daily at night.
Pain intensity will be evaluated daily at night by the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale scored from 0-10 representing 0 ("no pain") and 10 (Worst Possible Pain").
To assess the oral health-related quality of life
The oral health-related quality of life will be evaluated daily at night by the adapted Oral Health Impact Profile (OHIP) questionary.
Percentage of participants healed after 3 days of treatment.
Percentage of participants healed after 3 days of treatment, defined as ulcer diameter = 0 mm and pain intensity = 0, 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").
Percentage of participants with no pain after 3 days of treatment.
Percentage of participants with no pain after 3 days of treatment, defined as pain intensity = 0, 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").
Global assessment of treatment by participant after 3 days of treatment
The global evaluation of the treatment after 3 days of treatment will be evaluated by the categorical scale of 5 points representing 0 = very bad, 1 = bad, 2 = indifferent, 3 = good and 4 = very good.

Full Information

First Posted
March 6, 2023
Last Updated
March 20, 2023
Sponsor
EMS
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1. Study Identification

Unique Protocol Identification Number
NCT05772338
Brief Title
Efficacy and Safety of BNP105 in the Treatment of Recurrent Aphthous Stomatitis
Official Title
National, Multicenter, Randomized, Double-blind, Pilot Study to Evaluate the Efficacy and Safety of BNP105 in the Treatment of Recurrent Aphthous Stomatitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 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 BNP105 in the treatment of recurrent aphthous stomatitis.

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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BNP105 (25 + 25 + 15)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BNP105 (25 + 25 + 15)
Intervention Description
BNP105 oral suspension, 25 mg + 25 mg + 15 mg, oral. Up to six applications per day.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo. Up to six applications per day.
Primary Outcome Measure Information:
Title
To assess the change in pain intensity after the first application.
Description
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").
Time Frame
3 and 10 minutes
Secondary Outcome Measure Information:
Title
To assess the change 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 100 mm line, with two end points representing 0 ("no pain") and 100 (Worst Possible Pain").
Time Frame
3 days
Title
To assess the pain intensity daily after breakfast, lunch and dinner.
Description
Pain intensity will be evaluated daily after breakfast, lunch and dinner by the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale scored from 0-10 representing 0 ("no pain") and 10 (Worst Possible Pain").
Time Frame
7 days
Title
To assess the pain intensity daily at night.
Description
Pain intensity will be evaluated daily at night by the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale scored from 0-10 representing 0 ("no pain") and 10 (Worst Possible Pain").
Time Frame
7 days
Title
To assess the oral health-related quality of life
Description
The oral health-related quality of life will be evaluated daily at night by the adapted Oral Health Impact Profile (OHIP) questionary.
Time Frame
7 days
Title
Percentage of participants healed after 3 days of treatment.
Description
Percentage of participants healed after 3 days of treatment, defined as ulcer diameter = 0 mm and pain intensity = 0, 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").
Time Frame
3 days
Title
Percentage of participants with no pain after 3 days of treatment.
Description
Percentage of participants with no pain after 3 days of treatment, defined as pain intensity = 0, 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").
Time Frame
3 days
Title
Global assessment of treatment by participant after 3 days of treatment
Description
The global evaluation of the treatment after 3 days of treatment will be evaluated by the categorical scale of 5 points representing 0 = very bad, 1 = bad, 2 = indifferent, 3 = good and 4 = very good.
Time Frame
3 days

10. Eligibility

Sex
Female
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; 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). 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
ZIP/Postal Code
13183-250
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassiano Ricardo O Berto
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 BNP105 in the Treatment of Recurrent Aphthous Stomatitis

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