Main
|
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. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT00226889 |
Date of registration:
|
23/09/2005 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Treatment of Early Systemic Sclerosis by Bosentan
TRANOS |
Scientific title:
|
|
Date of first enrolment:
|
January 2005 |
Target sample size:
|
30 |
Recruitment status: |
Terminated |
URL:
|
http://clinicaltrials.gov/show/NCT00226889 |
Study type:
|
Interventional |
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
Phase:
|
Phase 1/Phase 2
|
|
Countries of recruitment
|
Norway
| | | | | | | |
Contacts
|
Name:
|
Jan T Gran, Professor |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
department of rheumatology |
| | |
Key inclusion & exclusion criteria
|
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 -
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Systemic Sclerosis (Scleroderma)
|
Intervention(s)
|
Drug: bosentan
|
Primary Outcome(s)
|
Overall clinical progression
|
Degree of deposition of ET-1 in skin
|
Secondary Outcome(s)
|
Quality of life
|
Development of extradermatological manifestations
|
Secondary ID(s)
|
EUDRACTNR.2004-000650-23
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|