Ulcer, AphthousPhase 2NCT00281723
Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)
A Phase 2 study testing Pro-Pe adhesive tablet in people with Ulcer, Aphthous, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer, Aphthous
- What is being tested?
- Pro-Pe adhesive tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Age above 18 years old.
- Non-pregnant women.
- Healthy or controlled chronic diseases.
- Examination at the Oral Medicine Clinic
- Age above 18 years old.
- Non-pregnant women.
- Clinical diagnosis of RAS.
- Examination at the Oral Medicine Clinic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ulcer, Aphthous
- Being tested
- Pro-Pe adhesive tablet
- Keywords
- Aphthous, oral
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-Pe adhesive tabletDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study completionMay 2007 (estimated)
Why it stopped: The company which holds the patent was not interested.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcer, AphthousStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Grant from "Axiomedic. Advanced Medical Solutions", Zurich, Switzerland
- Investigators
- Rakefet Czerninski, DMD, Principal investigator, Hebrew University-Hadassah School of Dental MedicineSharon Elad, DMD MSc, Principal investigator, Hebrew University-Hadassah School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281723
- Sponsor's protocol ID
- 6-12.2.06-HMO-CTIL
- Status last verified
- May 2007
- First submitted
- 24 Jan 2006
- Last updated
- 8 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15459950
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)
- ClinicalTrials.gov ID
- NCT00281723
- Acronym / sponsor ID
- 6-12.2.06-HMO-CTIL
- Conditions
- Ulcer, Aphthous
- Keywords
- Aphthous, oral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The company which holds the patent was not interested.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Grant from "Axiomedic. Advanced Medical Solutions", Zurich, Switzerland
- Study completion
- May 2007 (estimated)
- First posted
- 25 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age above 18 years old.
- Non-pregnant women.
- Healthy or controlled chronic diseases.
- Examination at the Oral Medicine Clinic
- Age above 18 years old.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pro-Pe adhesive tablet | Drug | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2007.
- Background: PubMed 15459950Mizrahi 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.
- Company websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakefet Czerninski, DMD principal investigator
Hebrew University-Hadassah School of Dental Medicine
Sharon Elad, DMD MSc principal investigator
Hebrew University-Hadassah School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pro-Pe adhesive tablet in people with Ulcer, Aphthous, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00281723, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2007.