Brief Title
A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis
Brief Summary
This is a randomized, double blind, placebo controlled trial of the use of pentoxifylline
(oxpentifylline) for the treatment of recurrent mouth ulcers.
Detailed Description
There are few effective treatments for recurrent aphthous stomatitis (cancer sores, recurrent
mouth ulcers). Most existing treatments are palliative topical treatments. Some systemic
drugs e.g. steroids and thalidomide can suppress the recurrence of mouth ulcers but have
serious long term side effects. Pentoxifylline (also known as oxpentifylline) has been used
systemically for many years to treat peripheral vascular disease and has a good side effect
profile. It shares several actions with thalidomide but does not share its serious side
effects. Furthermore, some small scale, open label clinical studies have indicated it may be
very effective in treating recurrent aphthous stomatitis (RAS). This study enrolled patients
with RAS for which no underlying cause could be identified. Patients kept a diary of the
pattern of their mouth ulcers for 60 days to confirm the pattern of ulceration and provide
baseline data. Those still qualified for the study were then randomized to treatment with
pentoxifylline 400mg three times daily or an identical placebo tablet three times daily for a
further 60 days during which they continued to keep a daily ulcer diary. At the end of this
period, treatment was stopped and they kept the daily ulcer diary for a further 60 days to
identify if any benefit from the treatment was continued after ceasing treatment.
Study Type
Interventional
Primary Outcome
Reduction in the median pain score
Secondary Outcome
Change in global ulcer severity score
Condition
Recurrent Aphthous Stomatitis
Intervention
Pentoxifylline (also known as oxpentifylline)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
June 1996
Completion Date
November 1998
Primary Completion Date
November 1998
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of minor recurrent aphthous stomatitis
- 2 or more mouth ulcers per month for more than 6
- No current treatment for oral ulceration or willing to stop treatment
- Age 16 to 65 years
Exclusion Criteria:
- Taking ketorolac, theophylline or anti-hypertensive medication except diuretics
(contra-indicated in patients treated with pentoxifylline)
- Systemic diseases that contra-indicate the use of pentoxifylline i.e. pregnancy,
hypotension, ischaemic heart disease, acute myocardial infarction, cerebral or occular
hemorrhage, renal or hepatic failure, porphyria or allergy to pentoxifylline.
- Patients with an underlying deficiency state or systemic disease that could cause
recurrent mouth ulcers e.g. iron, vitamin B12 or foliate deficience, coeliac disease,
Crohn's disease, ulcerative colitis, Behcet's disease or Aids.
Gender
All
Ages
16 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Martin H Thornhill, MBBS, BDS, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT00315679
Organization ID
MHT01
Study Sponsor
Manchester University NHS Foundation Trust
Study Sponsor
Martin H Thornhill, MBBS, BDS, Principal Investigator, University of Sheffield School of Clinical Dentistry
Verification Date
August 2018