Status:
TERMINATED
Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Schering-Plough
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study compared the efficacy of different dosages of long-term iloprost treatment on Raynaud's phenomenon, ulcer healing, skin thickening, and progression of internal organ sclerosis in systemic s...
Detailed Description
50 SSc patients (23 patients with limited SSc; 15 patients with diffuse SSc, and 12 patients with overlap syndromes fulfilling the ACR criteria for systemic sclerosis) and suffering from severe Raynau...
Eligibility Criteria
Inclusion
- patients with secondary Raynaud's phenomenon suffering from severe Raynaud-'s phenomenon with trophical changes or from digital ulcers with written informed consent. Patients had to be stable for their systemic disease and were on stable medication concerning immunosuppression or vasoactive therapies for three months.
Exclusion
- Current smokers, patients with a history of gastric ulcers in the last three months, a cardiac ejection fraction below 25%, patients with severe organ involvement or other uncontrolled diseases such as instable angina pectoris, severe anaemia, coagulopathies, azothaemia, cerebral stroke in the last 6 months or malignant diseases were excluded from the study. The last iloprost therapy had to be finished at least 6 months ago. Participation in other studies during the last 4 weeks was also not allowed. For fertile women, a negative pregnancy test was required.
Key Trial Info
Start Date :
September 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00622687
Start Date
September 1 1997
End Date
December 1 2007
Last Update
February 25 2008
Active Locations (1)
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1
Charrité Universitätsmedizin
Berlin, State of Berlin, Germany, 10117