Trial record 10 of 18 for:    "Aphthous stomatitis"

A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis

This study has been completed.
Sponsor:
Information provided by:
Central Manchester University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00315679
First received: April 18, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

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


Condition Intervention
Recurrent Aphthous Stomatitis
Drug: Pentoxifylline (also known as oxpentifylline)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Central Manchester University Hospitals NHS Foundation Trust:

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

Estimated Enrollment: 30
Study Start Date: June 1996
Estimated Study Completion Date: November 1998
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.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315679

Locations
United Kingdom
University Dental Hospital of Manchester
Manchester, United Kingdom, M15 6FH
Sponsors and Collaborators
Central Manchester University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Martin H Thornhill, MBBS, BDS University of Sheffield School of Clinical Dentistry
  More Information

No publications provided by Central Manchester University Hospitals NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00315679     History of Changes
Other Study ID Numbers: MHT01
Study First Received: April 18, 2006
Last Updated: April 18, 2006
Health Authority: United Kingdom: National Health Service

Keywords provided by Central Manchester University Hospitals NHS Foundation Trust:
recurrent aphthous stomatitis
recurrent mouth ulcers
pentoxifylline
clinical trial
double blind
placebo controlled
randomized

Additional relevant MeSH terms:
Stomatitis
Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases
Pentoxifylline
Antioxidants
Cardiovascular Agents
Enzyme Inhibitors
Free Radical Scavengers
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Radiation-Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 22, 2014