Status:
COMPLETED
Effect of Bosentan on Skin Fibrosis in Patients With Systemic Sclerosis
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Systemic Scleroderma
Skin Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Endothelin-1 is a potent vasoconstrictor and binds to two receptors, ET-A and ET-B, which are variable expressed on endothelial cells, smooth muscle cells, and fibroblasts. Furthermore, endothelin-1 h...
Detailed Description
Systemic sclerosis (SSc) is a polymorphic disorder with an unknown cause characterized by fibrosis of the skin, blood vessels, and visceral organs. The degree of skin involvement is a very important o...
Eligibility Criteria
Inclusion
- Patients with systemic sclerosis (diffuse SSc, limited SSc)
- ACR criteria fulfilled
- Current areas of skin fibrosis due to SSc
- Women postmenopausal or negative pre-treatment pregnancy test as well as a reliable method of contraception during study treatment and for at least 3 months after study treatment termination
- Signed informed consent
Exclusion
- Severe PAH or interstitial lung disease (WHO class III and IV)
- Skin fibrosis and digital ulcers (DUs) due to conditions other than SSc
- Systolic BP \< 85 mmHg
- Hemoglobin concentration \< 75% of the lower limit of the normal range
- AST and/or ALT values greater than 3 times the upper limit of normal
- Moderate to severe hepatic impairment
- Severe malabsorption, severe organ failure or any life threatening condition
- Breast feeding
- Treatment with any of the following drugs: glibenclamide (glyburide), cyclosporine A, and tacrolimus 1 week prior to study participation
- Treatment with parenteral prostanoids 3 months prior to study participation
- Treatment with inhaled, subcutaneous or oral prostanoids 1 month prior to registration
- Systemic antibiotics to treat infection of DUs 2 weeks prior to study participation
- Current treatment with phosphodiesterase inhibitors such as sildenafil, except for intermittent treatment of male erectile dysfunction
- Patient with conditions that prevent compliance with the protocol or adhering to therapy
- Patient who received an investigational product within 1 month preceding screening
- Known hypersensitivity to bosentan or any of the excipients
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00318175
Start Date
June 1 2006
End Date
May 1 2007
Last Update
September 10 2007
Active Locations (1)
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1
Heinrich-Heine-University of Duesseldorf, Department of Dermatology
Düsseldorf, North Rhine-Westphalia, Germany, 40225