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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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19 February 2015 |
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Main ID: |
NCT00428883 |
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Date of registration:
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29/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis
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Scientific title:
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Rare Disease With Microvascular Involvement: High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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45 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00428883 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Italy
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Contacts
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Name:
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Armando Gabrielli, MD,professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Università Politecnica delle Marche |
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Name:
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Armando Gabrielli, MD,Professor |
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Address:
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Telephone:
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+390712206101 |
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Email:
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a.gabrielli@univpm.it |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of early diffuse scleroderma
- ability to give an informed consent
- use of an acceptable method of birth control (if women in childbearing age).
Pregnancy will be ruled out before study beginning.
Exclusion Criteria:
- connective tissue diseases or other autoimmune diseases other than SSc;
- history of intolerance to the study drugs;
- severe cardiac failure (NYHA >=3 or left ventricular ejection fraction <40%), recent
(<6 months) history of myocardial infarction; symptomatic ischemic myocardial
disease, ventricular tachyarrhythmia, atrial fibrillation;
- resting PaO2 <60mm/hg
- creatinine clearance below 90ml/h
- severe hepatic failure
- bronchial asthma h. hemorrhagic diathesis i. pregnancy or lactation
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Scleroderma, Diffuse
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Intervention(s)
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Drug: N-acetylcysteine (NAC)
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Primary Outcome(s)
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The primary outcome is the reduction of skin thickness
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Evaluated by the modified Rodnan skin score.
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Secondary Outcome(s)
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laboratory evidence of skin fibroblast activation;
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the levels of Glutathione and of oxidized glutathione (GSSG).
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patient physical and emotional well-being (VAS, HAQ, SF36)
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scleroderma disease activity assessed as established
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Secondary ID(s)
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FARM5X8AWM
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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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