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A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis

Primary Purpose

Recurrent Aphthous Stomatitis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pentoxifylline (also known as oxpentifylline)
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Aphthous Stomatitis focused on measuring recurrent aphthous stomatitis, recurrent mouth ulcers, pentoxifylline, clinical trial, double blind, placebo controlled, randomized

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Dental Hospital of Manchester

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2006
Last Updated
August 1, 2018
Sponsor
Manchester University NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00315679
Brief Title
A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 1996 (undefined)
Primary Completion Date
November 1998 (Actual)
Study Completion Date
November 1998 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Manchester University NHS Foundation Trust

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Aphthous Stomatitis
Keywords
recurrent aphthous stomatitis, recurrent mouth ulcers, pentoxifylline, clinical trial, double blind, placebo controlled, randomized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pentoxifylline (also known as oxpentifylline)
Primary Outcome Measure Information:
Title
Reduction in the median pain score
Title
Reduction in the median ulcer size
Title
Reduction in the median ulcer number
Title
Reduction in the total number of episodes of ulceration (RAS)
Secondary Outcome Measure Information:
Title
Change in global ulcer severity score
Title
Increase in the proportion of ulcer free days
Title
Difference in the proportion of ulcer free days (comparing trial v baseline)
Title
Side effect incidence
Title
Side effect type

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin H Thornhill, MBBS, BDS
Organizational Affiliation
University of Sheffield School of Clinical Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Dental Hospital of Manchester
City
Manchester
ZIP/Postal Code
M15 6FH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17438178
Citation
Thornhill MH, Baccaglini L, Theaker E, Pemberton MN. A randomized, double-blind, placebo-controlled trial of pentoxifylline for the treatment of recurrent aphthous stomatitis. Arch Dermatol. 2007 Apr;143(4):463-70. doi: 10.1001/archderm.143.4.463. Erratum In: Arch Dermatol. 2007 Jun;143(6):716.
Results Reference
derived

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A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis

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