Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315679
Status:
COMPLETED
Last Update Posted:
2018-08-03
First Post:
2006-04-18
Brief Title:
A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis
Sponsor:
Manchester University NHS Foundation Trust
Organization:
Manchester University NHS Foundation Trust
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None