Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)
Primary Purpose
Ulcer, Aphthous
Status
Suspended
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Pro-Pe adhesive tablet
Sponsored by
About this trial
This is an interventional treatment trial for Ulcer, Aphthous focused on measuring Aphthous, oral
Eligibility Criteria
Inclusion Criteria (in healthy individuals): Age above 18 years old. Non-pregnant women. Healthy or controlled chronic diseases. Examination at the Oral Medicine Clinic Inclusion Criteria (in RAS patients): Age above 18 years old. Non-pregnant women. Clinical diagnosis of RAS. Examination at the Oral Medicine Clinic Exclusion Criteria: Oral lesion suspected to be malignant. Ulcerative oral lesion other than RAS. Another experimental oral intervention within the last 24 hours. Pregnant women. Allergy to components of the Pro-pe adhesive tablet
Sites / Locations
- Hadassah Medical Organization,
Outcomes
Primary Outcome Measures
Serial questionnaires within 1 week post treatment to assess patient's perception, patient's pain relief and local adverse events in comparison to his past experience with other local treatments for oral ulcers.
Secondary Outcome Measures
Full Information
NCT ID
NCT00281723
First Posted
January 24, 2006
Last Updated
May 6, 2007
Sponsor
Hadassah Medical Organization
Collaborators
Grant from "Axiomedic. Advanced Medical Solutions", Zurich, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT00281723
Brief Title
Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)
Official Title
Phase 2 Study of Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Suspended
Why Stopped
The company which holds the patent was not interested.
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
Collaborators
Grant from "Axiomedic. Advanced Medical Solutions", Zurich, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Recurrent Aphthous Stomatitis (RAS) of the oral mucosa is a common and painful condition. Despite advances in therapeutic means there is still necessary to find a way to alleviate the local pain and discomfort induced by the mucosal ulceration.
The hypothesis was to study the effectiveness and acceptance of a herbal adhesive tablets in the treatment of RAS.
Participants in the study will be examined for oral lesions, will be instructed how to apply the oral-tablet, and will be interviewed during the follow-up period up to one week after the application.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcer, Aphthous
Keywords
Aphthous, oral
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pro-Pe adhesive tablet
Primary Outcome Measure Information:
Title
Serial questionnaires within 1 week post treatment to assess patient's perception, patient's pain relief and local adverse events in comparison to his past experience with other local treatments for oral ulcers.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria (in healthy individuals):
Age above 18 years old.
Non-pregnant women.
Healthy or controlled chronic diseases.
Examination at the Oral Medicine Clinic
Inclusion Criteria (in RAS patients):
Age above 18 years old.
Non-pregnant women.
Clinical diagnosis of RAS.
Examination at the Oral Medicine Clinic
Exclusion Criteria:
Oral lesion suspected to be malignant.
Ulcerative oral lesion other than RAS.
Another experimental oral intervention within the last 24 hours.
Pregnant women.
Allergy to components of the Pro-pe adhesive tablet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakefet Czerninski, DMD
Organizational Affiliation
Hebrew University-Hadassah School of Dental Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharon Elad, DMD MSc
Organizational Affiliation
Hebrew University-Hadassah School of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization,
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
15459950
Citation
Mizrahi B, Golenser J, Wolnerman JS, Domb AJ. Adhesive tablet effective for treating canker sores in humans. J Pharm Sci. 2004 Dec;93(12):2927-35. doi: 10.1002/jps.20193.
Results Reference
background
Links:
URL
http://www.axiomedic.com
Description
Company website
Learn more about this trial
Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)
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