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The purpose of this study is to evaluate the efficacy and safety of BNP105 in the treatment of recurrent aphthous stomatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNP105 (25 + 25 + 15) | Drug | BNP105 oral suspension, 25 mg + 25 mg + 15 mg, oral. Up to six applications per day. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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"). | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EMS | Not yet recruiting | Hortolândia | São Paulo | 13183-250 | Brazil |
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| ID | Term |
|---|---|
| D013281 | Stomatitis, Aphthous |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Placebo | Other | Placebo. Up to six applications per day. |
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| 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"). |
| 7 days |
| 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"). | 7 days |
| 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. | 7 days |
| 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"). | 3 days |
| 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"). | 3 days |
| 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. | 3 days |
| Cecip Jau - Centro de Estudos Clinicos Do Interior Paulista Ltda | Recruiting | Jaú | São Paulo | 17210-190 | Brazil |
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