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Treatment of Early Systemic Sclerosis by Bosentan (TRANOS)

This study has been terminated.
(failure of recruiting a sufficient number of patients)
Information provided by:
Rikshospitalet University Hospital Identifier:
First received: September 23, 2005
Last updated: June 11, 2009
Last verified: March 2006
Systemic sclerosis (ssc) is characterised by extensive tissue fibrosis. Using drugs that are capable of inhibiting fibroblast activity may be beneficial if administrered early in the disease course. Thirty adult patients with early SSc will be treated with the endothelin-1 antagonist bosentan for 6 months.Disease progression will be assessed.

Condition Intervention Phase
Systemic Sclerosis (Scleroderma)
Drug: bosentan
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Rikshospitalet University Hospital:

Primary Outcome Measures:
  • Overall clinical progression
  • Degree of deposition of ET-1 in skin

Secondary Outcome Measures:
  • Development of extradermatological manifestations
  • Quality of life

Estimated Enrollment: 30
Study Start Date: January 2005
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Systemic sclerosis (SSc) is characterised by obliterative vasculopathy and extensive fibrosis. The accumulation of extracellular components in the extracellular matrix is mostly due to increased activity og tissue fibroblasts. The proliferation and hyperactivity of the fibroblasts may be caused by enhanced production of several cytokins, among them endothelin-1.The activity of endothelin-1 has been shown to be increased both in the circulation and within skin lesions. Endothelin-1 has several distinct properties, among them profibrotic activity, inflammatory and vasoconstriction.Thus, the actions induced by endothelin-1 may be a potensial target for the therapy of SSc.

Thirty patients with early SSc, that is of less than 12 months duration will be offered six months of treatment with the oral dual endothelin-1 antagonist bosentan. Assessment of disease progression will be performed at 3, 6, 9. 12 and 24 months using clinical, histological and immunohistochemical methods.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Early systemic sclerosis

Exclusion Criteria:

  • Age > 70 or < 18
  • Pregnancy
  • Nursing
  • HIV
  • Hb < 8.5 g/l
  • Systolic blood pressure < 85 mmHg
  • Lack of compliance
  • Liver disease
  • Hypersensitivity to bosentan
  • Concurrent us of glibenclamide, ciclosporine A or tacrolimus -
  Contacts and Locations
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Please refer to this study by its identifier: NCT00226889

Department of rheumatology, Rikshospitalet
Oslo, Norway, 0026
Sponsors and Collaborators
Rikshospitalet University Hospital
Study Director: Jan T Gran, Professor department of rheumatology
  More Information Identifier: NCT00226889     History of Changes
Other Study ID Numbers: EUDRACTNR.2004-000650-23
Study First Received: September 23, 2005
Last Updated: June 11, 2009

Keywords provided by Rikshospitalet University Hospital:

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017