Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000114044
Ethics application status
Approved
Date submitted
26/11/2009
Date registered
3/02/2010
Date last updated
5/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized double blind, placebo-controlled clinical trial with oral n-acetylcysteine in systemic sclerosis patients and assessment of skin blood flow of the hands with laser Doppler perfusion imaging
Scientific title
Oral N-acetylcysteine in the Treatment of Raynaud's Phenomenon Secondary to Systemic Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Secondary ID [1] 1293 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
microcirculation 252292 0
systemic sclerosis 256431 0
fingertip blood flow 256432 0
Condition category
Condition code
Inflammatory and Immune System 252472 252472 0 0
Connective tissue diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
participants will receive capsules with n-acetylcysteine 600 mg three applications per day orally for 4 weeks to be provided by a developer who did not attend the previous steps
Intervention code [1] 241609 0
Treatment: Drugs
Comparator / control treatment
the placebo group received capsules containing corn starch at the same dose of n-acetylcysteine and the same physical characteristics
Control group
Placebo

Outcomes
Primary outcome [1] 253347 0
improvement finger blood flow by laser Doppler perfusion imaging
Timepoint [1] 253347 0
blood flow of the fingertips will be evaluated at 0, 1 minute, 4 minutes, 17 minutes, 20 minutes, 10 minutes and 27 minutes before and after cold stimulation at week 1 and at 0, 1 minutes, 4 minutes, 17 minutes, 20 minutes, 10 minutes and 27 minutes after cold stimulation before and after 4 weeks of treatment with n-acetylcysteine or placebo
Secondary outcome [1] 262424 0
improvement of pain and severity of Raynaud phenomenon by visual analogical scale
Timepoint [1] 262424 0
30 minutes after cold stimulus before and after 4 weeks of treatment with drug or placebo

Eligibility
Key inclusion criteria
Raynaud phenomenon secondary to systemic sclerosis with pain
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
smokers and diabetes

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
after the election of participants for the study and signing the consent and prior knowledge they were allocated using the minitab softtware per participant who was not involved in other stages of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
by software minitab
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/08/2008
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] 2342 0
Brazil
State/province [1] 2342 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 256089 0
Other
Name [1] 256089 0
Foundation for the support for research in the state of Sao Paulo
Country [1] 256089 0
Brazil
Primary sponsor type
Other
Name
Foundation for the support for research in the state of Sao Paulo
Address
R. Pio XI, 1500 - Alto da Lapa - CEP 05468-901 - Sao Paulo/SP - Brasil
Country
Brazil
Secondary sponsor category [1] 251544 0
None
Name [1] 251544 0
Address [1] 251544 0
Country [1] 251544 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258180 0
Ethics committee from Federal University of Sao Paulo
Ethics committee address [1] 258180 0
Ethics committee country [1] 258180 0
Brazil
Date submitted for ethics approval [1] 258180 0
05/02/2006
Approval date [1] 258180 0
06/02/2006
Ethics approval number [1] 258180 0
1/06/1298

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

Contacts
Principal investigator
Name 30552 0
Address 30552 0
Country 30552 0
Phone 30552 0
Fax 30552 0
Email 30552 0
Contact person for public queries
Name 13799 0
Marcelo Jose Uchoa Correa
Address 13799 0
Rua Botucatu, 740, Vila Clementino, Sao Paulo, SP, CEP 04023062
Country 13799 0
Brazil
Phone 13799 0
+55 11 55796665
Fax 13799 0
Email 13799 0
[email protected]
Contact person for scientific queries
Name 4727 0
Marcelo Jose Uchoa Correa
Address 4727 0
Rua Botucatu, 740, Vila Clementino, Sao Paulo, SP, CEP 04023062
Country 4727 0
Brazil
Phone 4727 0
+55 11 55796665
Fax 4727 0
Email 4727 0
[email protected]

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.