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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02798055 |
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Date of registration:
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03/06/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis
GRegistry SCDU |
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Scientific title:
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A National, Observational, Multi-center Registry to Examine the Characteristics of Patients With Systematic Sclerosis Digital Ulcers and Assess Bosentan Treatment. |
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Date of first enrolment:
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September 30, 2016 |
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Target sample size:
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148 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02798055 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Greece
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Both genders >18 and < 80 years
- ACR 2013 criteria >9 & =9
- At least one Digital Ulcer
- Raynaud Severity Scale (0-10)
Exclusion Criteria:
- < 18 years
- ACR 2013 criteria <9
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Digital Ulcer
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Systematic Sclerosis
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Scleroderma
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Intervention(s)
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Drug: Bosentan group
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Primary Outcome(s)
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Complications of systems
[Time Frame: 4 months]
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Reynaud Severity Scale
[Time Frame: 4 months]
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Modified Rodnan Skin Score - MRSS
[Time Frame: 4 months]
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Number of Ulcers
[Time Frame: 4 months]
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Secondary Outcome(s)
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Adverse Events
[Time Frame: 4 months]
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Secondary ID(s)
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2016-BSN-EL-64
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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