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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
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcer, Aphthous focused on measuring Aphthous, oral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

First Posted
January 24, 2006
Last Updated
May 6, 2007
Sponsor
Hadassah Medical Organization
Collaborators
Grant from "Axiomedic. Advanced Medical Solutions", Zurich, Switzerland
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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

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Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

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