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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
  Purpose

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.


Condition Intervention Phase
Ulcer, Aphthous
Drug: Pro-Pe adhesive tablet
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

Further study details as provided by Hadassah Medical Organization:

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.

Estimated Enrollment: 50
Estimated Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281723

Locations
Israel
Hadassah Medical Organization,
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Grant from "Axiomedic. Advanced Medical Solutions", Zurich, Switzerland
Investigators
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
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00281723     History of Changes
Other Study ID Numbers: 6-12.2.06-HMO-CTIL
Study First Received: January 24, 2006
Last Updated: May 6, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Aphthous
oral

Additional relevant MeSH terms:
Oral Ulcer
Stomatitis, Aphthous
Ulcer
Mouth Diseases
Pathologic Processes
Stomatitis
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 20, 2014