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High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Università Politecnica delle Marche.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Università Politecnica delle Marche
ClinicalTrials.gov Identifier:
NCT00428883
First received: January 29, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose
  • 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 some features of scleroderma phenotype are well established and represent the hallmarks of the disease, the primary cause is not fully delineated, though both endothelial cell damage, immunological abnormalities and excessive extracellular matrix production are well-documented
  • Recently, excessive oxidative stress has been implicated in the pathogenesis of scleroderma
  • N-acetylcysteine (NAC) exhibits direct and indirect antioxidant properties. Its free thiol group is capable of interacting with the electrophilic groups of ROS. This interaction with ROS leads to intermediate formation of NAC thiol, with NAC disulphide as a major end product. The net result is a decrease of the concentrations of OH-, H2O2, and HOCl. In addition, NAC exerts an indirect antioxidant effect related to its role as a glutathione (GSH) precursor. It serves as a central factor in protecting against internal toxic agents.
  • In view of these considerations we expect that NAC can confer substantial benefit in patients with scleroderma reducing skin fibrosis in view of its antioxidant properties, and we have decided to conduct a double blind, multicenter trial to establish whether NAC could ameliorate skin fibrosis in scleroderma patients

Condition Intervention Phase
Scleroderma, Diffuse
 Drug: N-acetylcysteine (NAC)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Rare Disease With Microvascular Involvement: High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Università Politecnica delle Marche:

Primary Outcome Measures:
  • The primary outcome is the reduction of skin thickness
  • Evaluated by the modified Rodnan skin score.

Secondary Outcome Measures:
  • scleroderma disease activity assessed as established
  • patient physical and emotional well-being (VAS, HAQ, SF36)
  • laboratory evidence of skin fibroblast activation;
  • the levels of Glutathione and of oxidized glutathione (GSSG).

Estimated Enrollment: 45
Study Start Date: January 2007
Estimated Study Completion Date: February 2009
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428883

Contacts
Contact: Armando Gabrielli, MD,Professor +390712206101 a.gabrielli@univpm.it
Contact: Giovanni Pomponio, MD +390715964209 g.pomponio@ao-umbertoprimo.marche.it

Locations
Italy
Università politecnica delle marche Recruiting
Ancona, Italy, 60020
Contact: Armando Gabrielli, MD,professor     +390712206104     a.gabrielli@univpm.it    
Contact: Giovanni Pomponio, MD     +390715964205     g.pomponio@ao-umbertoprimo.marche.it    
Principal Investigator: Armando Gabrielli, MD,professor            
Università de L’Aquila Recruiting
Aquila, Italy
Contact: Roberto Giacomelli, Ph         roberto.giacomelli@cc.univaq.it    
Principal Investigator: Roberto Giacomelli, MD,professor            
Università di Firenze Recruiting
Firenze, Italy
Contact: Marco Matucci-Cerinic, MD,professor         cerinic@unifi.it    
Principal Investigator: Marco Matucci-Cerinic, MD,professor            
Seconda Università di Napoli Recruiting
Napoli, Italy
Contact: Gabriele Valentini, MD,professor         gabriele.valentini@unina2.it    
Principal Investigator: Gabriele Valentini, MD,professor            
Catholic University of the Sacred Recruiting
Roma, Italy
Contact: Gianfranco Ferraccioli, MD,professor            
Principal Investigator: Gianfranco Ferraccioli, MD,professor            
Sponsors and Collaborators
Università Politecnica delle Marche
Investigators
Principal Investigator: Armando Gabrielli, MD,professor Università Politecnica delle Marche
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00428883     History of Changes
Other Study ID Numbers: FARM5X8AWM
Study First Received: January 29, 2007
Last Updated: January 29, 2007
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Università Politecnica delle Marche:
Scleroderma, Systemic
Scleroderma, Diffuse

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Connective Tissue Diseases
Skin Diseases
Pathologic Processes
Acetylcysteine
N-monoacetylcystine
Iloprost
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Platelet Aggregation Inhibitors
Hematologic Agents
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013