Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000235303
Ethics application status
Approved
Date submitted
6/05/2008
Date registered
8/05/2008
Date last updated
16/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Topical capsaicin in burning mouth syndrome
Scientific title
The efficacy of topical capsaicin in reducing symptoms in patients with burning mouth syndrome
Universal Trial Number (UTN)
Trial acronym
BMS capsaicin
Linked study record

Health condition
Health condition(s) or problem(s) studied:
burning mouth syndrome 3123 0
Condition category
Condition code
Oral and Gastrointestinal 3287 3287 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be instructed to apply topical capsaicin 0.075%, twice a day (middle morning and middle afternoon) for 8 weeks with a one-week interval - the fourth.
Intervention code [1] 2869 0
Treatment: Drugs
Comparator / control treatment
The control group received placebo - the water based cream utilized as vehicle for the capsaicin, twice a day, 4 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 4174 0
relief of symptoms assessed through a visual analogue scale and a questionnaire of an overall effect perceived
Timepoint [1] 4174 0
4 weeks after starting medication or placebo, 8 weeks at the ending of drug administration and 12 weeks, four weeks after drug discontinuation.
Secondary outcome [1] 7049 0
lasting of the benefits achieved - relief of symptoms, measured through visual analogue scale and a questionnaire of an overall effect perceived
Timepoint [1] 7049 0
six months after discontinuation of drug treatment

Eligibility
Key inclusion criteria
burning mouth syndrome, no recent use of other drugs
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
diabetic patients, anemia, candida infection

Study design
Purpose of the study
Treatment
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
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 961 0
Brazil
State/province [1] 961 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 3365 0
University
Name [1] 3365 0
Sao Paulo University
Country [1] 3365 0
Brazil
Primary sponsor type
University
Name
Sao Paulo University
Address
Prof Lineu Prestes Av, 2227 Sao Paulo
PC 05508-000
Country
Brazil
Secondary sponsor category [1] 3012 0
Government body
Name [1] 3012 0
Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior (CAPES)
Address [1] 3012 0
Ministerio da Educacao, anexos I e II, Brasilia, DF, PC 70359-970
Country [1] 3012 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5383 0
Sao Paulo University, School of Dentistry Ethics Committee
Ethics committee address [1] 5383 0
Ethics committee country [1] 5383 0
Brazil
Date submitted for ethics approval [1] 5383 0
Approval date [1] 5383 0
10/08/2007
Ethics approval number [1] 5383 0

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

Contacts
Principal investigator
Name 28569 0
Address 28569 0
Country 28569 0
Phone 28569 0
Fax 28569 0
Email 28569 0
Contact person for public queries
Name 11726 0
norberto nobuo sugaya
Address 11726 0
Prof Lineu Prestes Av, 2227 Sao Paulo
PC 05508-000
Country 11726 0
Brazil
Phone 11726 0
55 11 30917883
Fax 11726 0
55 11 30917883
Email 11726 0
nnsugaya@usp.br
Contact person for scientific queries
Name 2654 0
bianca fréo
Address 2654 0
Prof Lineu Prestes Av, 2227 Sao Paulo
PC 05508-000
Country 2654 0
Brazil
Phone 2654 0
55 11 98908221
Fax 2654 0
Email 2654 0
bifreo@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.