An interventional study of Pentoxifylline (also known as oxpentifylline) in Recurrent Aphthous Stomatitis, sponsored by Manchester University NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-03.
Sponsored by Manchester University NHS Foundation Trust · Not applicable, Interventional, and Treatment
This is a randomized, double blind, placebo controlled trial of the use of pentoxifylline (oxpentifylline) for the treatment of recurrent mouth ulcers.
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.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's enrollment of 30 is below the median of 46 across 55 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →Manchester University NHS Foundation Trust is the lead sponsor of 139 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Reduction in the median pain score
Reduction in the median ulcer size
Reduction in the median ulcer number
Reduction in the total number of episodes of ulceration (RAS)
Change in global ulcer severity score
Increase in the proportion of ulcer free days
Difference in the proportion of ulcer free days (comparing trial v baseline)
Side effect incidence
Side effect type
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pentoxifylline
Manchester University NHS Foundation Trust →