Status:
UNKNOWN
High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis
Lead Sponsor:
Università Politecnica delle Marche
Conditions:
Scleroderma, Diffuse
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
* Systemic sclerosis (scleroderma; SSc) is a rare, disfiguring systemic disorder characterized by fibrosis of the skin and visceral organs that alters every aspect of an individual life * Although som...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
End Date :
February 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00428883
Start Date
January 1 2007
End Date
February 1 2009
Last Update
January 30 2007
Active Locations (5)
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1
Università politecnica delle marche
Ancona, Italy, 60020
2
Università di Firenze
Florence, Italy
3
Università de L'Aquila
L’Aquila, Italy
4
Seconda Università di Napoli
Napoli, Italy