Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000372381
Ethics application status
Approved
Date submitted
11/07/2008
Date registered
31/07/2008
Date last updated
31/07/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Systemic treatment in severe cases of recurrent aphthous stomatitis
Scientific title
A trial investigating the effects of thalidomide, dapsone, colchicine and/or pentoxifilline in preventing recurrent aphthous stomatitis (RAS) bouts in patients with severe RAS manifestations.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent aphthous stomatitis 3403 0
Condition category
Condition code
Inflammatory and Immune System 3550 3550 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
thalidomide - 100mg/day; 6 months, tablets orally
pentoxifylline - 400mg, three times/day; 6 months, tablets orally
colchicine - 0.5mg/day for 7 days; 1.0mg/day for 7 days; 1.5mg/day as maintenance dose; 6 months, tablets orally
dapsone - 25mg/day for 3 days; 50mg/day for 3 days; 75mg/day for 3 days; 100mg/day as maintenance dose; 6 months, tablets orally.
Subjects will receive any of the drugs listed above, switching from one drug to another according to their response to treatment and severity of adverse effects.
Subjects will be followed fortnightly for a 6-month period during medication use, and monthly for another 6 months of follow-up period.
As an open trial designs it will be considered the thalidomide group as a comparator (active control) due to the good results registered in previous trials, nevertheless the study will show some characteristics of a crossover study since if a patient do not get any improvement or exhibit severe adverse effects to the first given drug, that subject will be allocated to another testing drug.
Intervention code [1] 3126 0
Treatment: Drugs
Comparator / control treatment
to compare the power of preventing RAS bouts among the four drugs tested.
There is no standard treatment for severe RAS bouts, nevertheless thalidomide treatment should be considered as the best comparator due to good results obtained by previous trials.
Thalidomide, 100mg tablets, one per day, up to 6 months, avoiding its prescription to fertile women.
Control group
Active

Outcomes
Primary outcome [1] 4453 0
% of reduction of RAS bouts in patients with severe RAS manifestations.
Patients will be examined every two weeks during the period of medication use, for a 6-month period, when it will be recorded the history and clinical characteristics of RAS manifestations: number and frequency of relapses, number of lesions per bout and symptoms level (assessed by a five level scale - worsened, no improvement, mild improvement, moderate improvement and excellent improvement).
Subjects will be followed up monthly for another 6 months after medication withdrawal.
Timepoint [1] 4453 0
At baseline and at every two weeks, during 6 months
Secondary outcome [1] 7523 0
Adverse effects associated to each drug tested.
Patients on dapsone use will have their G6PD (glucose-6-phosphate-dehydrogenase) level checked before starting the drug and once a month during its use. Thalidomide will not be prescribed to fertile women.
Side effects will be categorized into three types: mild- minor gastrointestinal pain and transitory nausea; moderate- dizziness, fatigue, diarrhea, lethargy and headache; severe- hemolysis, jaundice and decreased hemoglobin level.
Adverse effects will be clinically assessed at patient's examination every two weeks.
Timepoint [1] 7523 0
At baseline and at every two weeks, during the time of drug administration, i.e., 6 months.

Eligibility
Key inclusion criteria
Patients with severe clinical course of RAS, i.e., multiple episodes of ulcers monthly
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with hematologic disease, Behçet's syndrome, Crohn's disease, Human immunodeficiency virus (HIV) infection or Reiter's syndrome.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/02/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 1038 0
Brazil
State/province [1] 1038 0

Funding & Sponsors
Funding source category [1] 3585 0
University
Name [1] 3585 0
Sao Paulo University
Country [1] 3585 0
Brazil
Primary sponsor type
Hospital
Name
Hospital das Clínicas, Sao Paulo University
Address
Av. Dr. Eneas de Carvalho Aguiar, 255
Cerqueira Cesar
05403-000
Sao Paulo
Country
Brazil
Secondary sponsor category [1] 3222 0
University
Name [1] 3222 0
Sao Paulo University
Address [1] 3222 0
Prof. Lineu Prestes Av., 2227
Cidade Universitaria
Sao Paulo
CEP 05508-000
Country [1] 3222 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5631 0
Sao Paulo University Medical School Ethics Committee
Ethics committee address [1] 5631 0
Ethics committee country [1] 5631 0
Brazil
Date submitted for ethics approval [1] 5631 0
Approval date [1] 5631 0
20/10/2003
Ethics approval number [1] 5631 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28744 0
Address 28744 0
Country 28744 0
Phone 28744 0
Fax 28744 0
Email 28744 0
Contact person for public queries
Name 11901 0
Norberto Nobuo Sugaya
Address 11901 0
Prof Lineu Prestes Av., 2227
Cidade Universitaria
Sao Paulo
CEP: 05508-000
Country 11901 0
Brazil
Phone 11901 0
55 11 30917883
Fax 11901 0
55 11 30917883
Email 11901 0
nnsugaya@usp.br
Contact person for scientific queries
Name 2829 0
Norberto Nobuo Sugaya
Address 2829 0
Prof Lineu Prestes Av., 2227
Cidade Universitaria
Sao Paulo
CEP: 05508-000
Country 2829 0
Brazil
Phone 2829 0
55 11 30917883
Fax 2829 0
55 11 30917883
Email 2829 0
nnsugaya@usp.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.