- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05959824
Devintec OR-AT0222 Oral Gel for the Treatment of Canker Sores: A Double Blind, Randomized, Placebo Controlled Clinical Investigation
Canker sore, also known as aphthous stomatitis or ulcers and aphthae, is a common ailment, idiopathic in nature, with recurrent painful aphthous ulcers on the non-keratinized oral mucous membranes.
Recurrent aphthous ulcer has higher prevalence in young adults and the frequency decreases with increasing age. The etiology of aphthous ulcer remains unclear. Other possible factors include trauma, drug use, deficiency in vitamin B12, folic acid, iron, stress, hormonal changes and metabolic diseases. Topical agents such as local antibiotics, local antiseptics, NSAIDs, and corticosteroids are generally prescribed for symptomatic relief. Several approved drug formulations such as pills, mouthwash, sprays and paste such as vitamin B12, chlorhexidine mouthwash, steroid lozenges and local anesthetics are primarily suggested for the treatment of aphthous ulcer. Despite the available local treatments, still sometimes oral canker sores may represent a painful burden for the patient and the gel OR-AT0222 may represent a topical product easy to use, well tolerated and effective local pain reliever, by facilitating the healing of the lesion(s).
The Sponsor, Devintec Sagl, presents OR-AT0222, indicated for the management of canker sores, aphthous stomatitis and small lesions of the mouth. The gel forms a persistent protective film with a "barrier effect" that promotes wound healing and protects the lesions of the oral cavity from contact with external agents, providing pain relief and reducing the risk of further irritation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Umberto Romeo
- Phone Number: +390649976611
- Email: umberto.romeo@uniroma1.it
Study Locations
-
-
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Rome, Italy, 00161
- Recruiting
- Policlinico "Umberto I" - U.O.C. di Odontoiatria Pediatrica ed Odontostomatologia
-
Contact:
- Umberto Romeo, MD, DDS, PhD
- Phone Number: +39 0649976611
- Email: umberto.romeo@uniroma1.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- >18 years (male and females)
- Patients have one oral canker sore, at least. Onset within 48 hours
- Patients in good condition with no serious systemic disease
Exclusion Criteria:
- Hypersensitivity to any OR-AT0222 ingredients
- Use of any medication to treat the ulcers the previous week before ORAT0222 gel use started or use of local medication or systemic drug during the treatment with OR-AT0222 gel.
- Underlying systemic disease(s) or a history of immunologic disorder(s);
- Taking immunomodulatory agents or systemic nonsteroidal antiinflammatory drugs < 1 month before study commencement;
- Smokers;
- Could not provide written informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Treatment with OR-AT0222
|
Topical viscous gel containing tamarind seed polysaccharide and isolated pea proteins will be used 3 times a day away from the main meals (breakfast lunch and dinner) for 7 days.
|
Placebo Comparator: Group 2
Treatment with Placebo
|
Topical placebo viscous gel will be used 3 times a day away from the main meals (breakfast lunch and dinner) for 7 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS score
Time Frame: 3xday, 30 minutes after each application for 7 days
|
Mean daily pain VAS score of the treatment group vs placebo.
|
3xday, 30 minutes after each application for 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily pain VAS score
Time Frame: 5, 10, 15 and 30 minutes after the first (morning) application of the gel, from baseline up to day 7
|
Daily pain VAS score at different time points
|
5, 10, 15 and 30 minutes after the first (morning) application of the gel, from baseline up to day 7
|
Pain disappearance
Time Frame: Daily assessments from baseline up to day 7
|
Mean days to pain disappearance in the treatment group respect to placebo
|
Daily assessments from baseline up to day 7
|
Pain free patients percentage
Time Frame: Daily assessments from baseline up to day 7
|
Percentage of patients who will report to be pain free according to the VAS scale
|
Daily assessments from baseline up to day 7
|
Ulcers reduction
Time Frame: Daily assessments from baseline up to day 7
|
Reduction of the number of ulcers respect to baseline
|
Daily assessments from baseline up to day 7
|
Lesions healing percentage
Time Frame: Daily assessments from baseline up to day 7
|
Percent of lesions with complete healing
|
Daily assessments from baseline up to day 7
|
Pain reduction
Time Frame: From baseline up to day 7
|
Reduction of pain (immediate relief on application, no burning sensation, measurement of how many days pain persists)
|
From baseline up to day 7
|
Safety
Time Frame: From baseline up to day 7
|
Number of Adverse Events and Serious Adverse Events
|
From baseline up to day 7
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DNT2022-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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