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Sponsored by: |
Central Manchester and Manchester Children's University hospitals NHS Trust |
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Information provided by: | Central Manchester and Manchester Children's University hospitals NHS Trust |
ClinicalTrials.gov Identifier: | NCT00315679 |
This is a randomized, double blind, placebo controlled trial of the use of pentoxifylline (oxpentifylline) for the treatment of recurrent mouth ulcers.
Condition | Intervention |
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Recurrent Aphthous Stomatitis |
Drug: Pentoxifylline (also known as oxpentifylline) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 30 |
Study Start Date: | June 1996 |
Estimated Study Completion Date: | November 1998 |
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.
Ages Eligible for Study: | 16 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
University Dental Hospital of Manchester | |
Manchester, United Kingdom, M15 6FH |
Principal Investigator: | Martin H Thornhill, MBBS, BDS | University of Sheffield School of Clinical Dentistry |
Study ID Numbers: | MHT01 |
Study First Received: | April 18, 2006 |
Last Updated: | April 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00315679 |
Health Authority: | United Kingdom: National Health Service |
recurrent aphthous stomatitis recurrent mouth ulcers pentoxifylline clinical trial |
double blind placebo controlled randomized |
Mouth Diseases Oral Ulcer Stomatitis Ulcer Stomatognathic Diseases |
Stomatitis, Aphthous Pentoxifylline Aphthous stomatitis Recurrence |
Disease Attributes Radiation-Protective Agents Vasodilator Agents Antioxidants Molecular Mechanisms of Pharmacological Action Hematologic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Cardiovascular Agents Protective Agents Pharmacologic Actions Pathologic Processes Phosphodiesterase Inhibitors Therapeutic Uses Free Radical Scavengers Platelet Aggregation Inhibitors |