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

Primary Purpose

Scleroderma, Diffuse

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
N-acetylcysteine (NAC)
Sponsored by
Università Politecnica delle Marche
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma, Diffuse focused on measuring Scleroderma, Systemic, Scleroderma, Diffuse

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Università politecnica delle marcheRecruiting
  • Università de L'AquilaRecruiting
  • Università di FirenzeRecruiting
  • Seconda Università di NapoliRecruiting
  • Catholic University of the SacredRecruiting

Outcomes

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).

Full Information

First Posted
January 29, 2007
Last Updated
January 29, 2007
Sponsor
Università Politecnica delle Marche
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1. Study Identification

Unique Protocol Identification Number
NCT00428883
Brief Title
High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis
Official Title
Rare Disease With Microvascular Involvement: High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Università Politecnica delle Marche

4. Oversight

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Diffuse
Keywords
Scleroderma, Systemic, Scleroderma, Diffuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
45 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine (NAC)
Primary Outcome Measure Information:
Title
The primary outcome is the reduction of skin thickness
Title
Evaluated by the modified Rodnan skin score.
Secondary Outcome Measure Information:
Title
scleroderma disease activity assessed as established
Title
patient physical and emotional well-being (VAS, HAQ, SF36)
Title
laboratory evidence of skin fibroblast activation;
Title
the levels of Glutathione and of oxidized glutathione (GSSG).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Armando Gabrielli, MD,Professor
Phone
+390712206101
Email
a.gabrielli@univpm.it
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Pomponio, MD
Phone
+390715964209
Email
g.pomponio@ao-umbertoprimo.marche.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Gabrielli, MD,professor
Organizational Affiliation
Università Politecnica delle Marche
Official's Role
Principal Investigator
Facility Information:
Facility Name
Università politecnica delle marche
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armando Gabrielli, MD,professor
Phone
+390712206104
Email
a.gabrielli@univpm.it
First Name & Middle Initial & Last Name & Degree
Giovanni Pomponio, MD
Phone
+390715964205
Email
g.pomponio@ao-umbertoprimo.marche.it
First Name & Middle Initial & Last Name & Degree
Armando Gabrielli, MD,professor
Facility Name
Università de L'Aquila
City
Aquila
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Giacomelli, Ph
Email
roberto.giacomelli@cc.univaq.it
First Name & Middle Initial & Last Name & Degree
Roberto Giacomelli, MD,professor
Facility Name
Università di Firenze
City
Firenze
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Matucci-Cerinic, MD,professor
Email
cerinic@unifi.it
First Name & Middle Initial & Last Name & Degree
Marco Matucci-Cerinic, MD,professor
Facility Name
Seconda Università di Napoli
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Valentini, MD,professor
Email
gabriele.valentini@unina2.it
First Name & Middle Initial & Last Name & Degree
Gabriele Valentini, MD,professor
Facility Name
Catholic University of the Sacred
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianfranco Ferraccioli, MD,professor
First Name & Middle Initial & Last Name & Degree
Gianfranco Ferraccioli, MD,professor

12. IPD Sharing Statement

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

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