## Protocol Section
### Identification Module
**NCT ID:** NCT00315679

**Brief Title:** A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis

#### Organization Study ID Info
**ID:** MHT01
#### Organization
**Class:** OTHER_GOV
**Full Name:** Manchester University NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 1998-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-08-03

**Type:** ACTUAL

**Last Update Submit Date:** 2018-08-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 1998-11

**Type:** ACTUAL

#### Start Date
**Date:** 1996-06

**Status Verified Date:** 2018-08

#### Study First Post Date
**Date:** 2006-04-19
**Type:** ESTIMATED
**Study First Submit Date:** 2006-04-18
**Study First Submit QC Date:** 2006-04-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Manchester University NHS Foundation Trust

### Description Module

**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.

### Conditions Module

**Conditions:**

- Recurrent Aphthous Stomatitis

**Keywords:**

- recurrent aphthous stomatitis

- recurrent mouth ulcers

- pentoxifylline

- clinical trial

- double blind

- placebo controlled

- randomized

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Pentoxifylline (also known as oxpentifylline)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Reduction in the median pain score

**Measure:** Reduction in the median ulcer size

**Measure:** Reduction in the median ulcer number

**Measure:** Reduction in the total number of episodes of ulceration (RAS)

#### Secondary Outcomes

**Measure:** Change in global ulcer severity score

**Measure:** Increase in the proportion of ulcer free days

**Measure:** Difference in the proportion of ulcer free days (comparing trial v baseline)

**Measure:** Side effect incidence

**Measure:** Side effect type

### Eligibility Module

**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.

**Maximum Age:** 65 Years

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Manchester

**Country:** United Kingdom

**Facility:** University Dental Hospital of Manchester

**Zip:** M15 6FH

#### Overall Officials

**Official 1:**

**Affiliation:** University of Sheffield School of Clinical Dentistry

**Name:** Martin H Thornhill, MBBS, BDS

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**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.

**PMID:** 17438178

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17206

- Name: Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M16070

- Name: Stomatitis

- Relevance: HIGH

- As Found: Stomatitis

- ID: M16071

- Name: Stomatitis, Aphthous

- Relevance: HIGH

- As Found: Aphthous Stomatitis

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Recurrent

- ID: M21213

- Name: Oral Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T455

- Name: Aphthous Stomatitis

- Relevance: HIGH

- As Found: Aphthous Stomatitis

### Condition Browse Module - Meshes

- ID: D000013280

- Term: Stomatitis

- ID: D000013281

- Term: Stomatitis, Aphthous

- ID: D000012008

- Term: Recurrence

### Intervention Browse Module - Ancestors

- ID: D000010726

- Term: Phosphodiesterase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000010975

- Term: Platelet Aggregation Inhibitors

- ID: D000011837

- Term: Radiation-Protective Agents

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014665

- Term: Vasodilator Agents

- ID: D000016166

- Term: Free Radical Scavengers

- ID: D000000975

- Term: Antioxidants

### Intervention Browse Module - Browse Branches

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M13342

- Name: Pentoxifylline

- Relevance: HIGH

- As Found: Renal Function

- ID: M13629

- Name: Phosphodiesterase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M13865

- Name: Platelet Aggregation Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14684

- Name: Radiation-Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M17412

- Name: Vasodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000010431

- Term: Pentoxifylline

### Misc Info Module

- Version Holder: 2024-05-24
