A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis

Recurrent Aphthous Stomatitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315679
• Other study ID #: MHT01
• Status: Completed
• Phase: N/A
• Start date: June 1996
• Est. completion date: November 1998

Study information

• Verified date: August 2018
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double blind, placebo controlled trial of the use of pentoxifylline (oxpentifylline) for the treatment of recurrent mouth ulcers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 1998
• Est. primary completion date: November 1998
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Recurrent Aphthous Stomatitis
• Stomatitis
• Stomatitis, Aphthous

Intervention

Drug:
• Pentoxifylline (also known as oxpentifylline)

Locations

Country	Name	City	State
United Kingdom	University Dental Hospital of Manchester	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the median pain score
Primary	Reduction in the median ulcer size
Primary	Reduction in the median ulcer number
Primary	Reduction in the total number of episodes of ulceration (RAS)
Secondary	Change in global ulcer severity score
Secondary	Increase in the proportion of ulcer free days
Secondary	Difference in the proportion of ulcer free days (comparing trial v baseline)
Secondary	Side effect incidence
Secondary	Side effect type