NCT00315679

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 1996

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1996

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1998

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2006

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

2.4 years

First QC Date

April 18, 2006

Last Update Submit

August 1, 2018

Conditions

Recurrent Aphthous Stomatitis

Keywords

recurrent aphthous stomatitisrecurrent mouth ulcerspentoxifyllineclinical trialdouble blindplacebo controlledrandomized

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • 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

Interventions

Pentoxifylline (also known as oxpentifylline)DRUG

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of minor recurrent aphthous stomatitis
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Dental Hospital of Manchester

Manchester, M15 6FH, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 17438178DERIVED

MeSH Terms

Conditions

Stomatitis, Aphthous

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

StomatitisMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Martin H Thornhill, MBBS, BDS

    University of Sheffield School of Clinical Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 19, 2006

Study Start

June 1, 1996

Primary Completion

November 1, 1998

Study Completion

November 1, 1998

Last Updated

August 3, 2018

Record last verified: 2018-08

Locations

GB(1)