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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: |
NCT00318175 |
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Date of registration:
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24/04/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Bosentan on Skin Fibrosis in Patients With Systemic Sclerosis
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Scientific title:
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Study to Assess the Effect of Bosentan on the Treatment of Skin Fibrosis in Patients With Systemic Sclerosis (BTSF) |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00318175 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Germany
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Contacts
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Name:
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Annegret Kuhn, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Heinrich-Heine-University of Duesseldorf, Department of Dermatology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Scleroderma
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Skin Fibrosis
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Hand Functionality
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Intervention(s)
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Drug: Bosentan (Tracleer)
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Primary Outcome(s)
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Measurable reduction of skin thickening using 20 MHz-ultrasound and the Rodnan Skin Score after treatment with study medication over 24 weeks in patients with systemic sclerosis.
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Secondary Outcome(s)
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Effect of bosentan on hand functionality measured by SHAQ, UK-functional score, and fist closure as well as on nitrosylated serum protein levels in the plasma of patients with systemic scleroderma.
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Secondary ID(s)
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2005-000798-23
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AMG 002
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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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