Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

This study has suspended participant recruitment.
(The company which holds the patent was not interested.)
Sponsor:
Collaborator:
Grant from "Axiomedic. Advanced Medical Solutions", Zurich, Switzerland
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00281723
First received: January 24, 2006
Last updated: May 6, 2007
Last verified: May 2007

January 24, 2006
May 6, 2007
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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.
Same as current
Complete list of historical versions of study NCT00281723 on ClinicalTrials.gov Archive Site
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Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)
Phase 2 Study of Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ulcer, Aphthous
Drug: Pro-Pe adhesive tablet
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
50
May 2007
Not Provided

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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00281723
6-12.2.06-HMO-CTIL
No
Not Provided
Hadassah Medical Organization
Grant from "Axiomedic. Advanced Medical Solutions", Zurich, Switzerland
Principal Investigator: Rakefet Czerninski, DMD Hebrew University-Hadassah School of Dental Medicine
Principal Investigator: Sharon Elad, DMD MSc Hebrew University-Hadassah School of Dental Medicine
Hadassah Medical Organization
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP