Overview

Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis

Status:
Terminated
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
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 sclerosis (SSc). Methods. 50 SSc patients were 1:1 randomised either for maximally tolerated dose up to 2 ng/kg body weight [bw] per minute or low dose (0.5 ng/kg bw per minute) intravenous iloprost administration, for six hours daily over 21 days. The effect on RP, ulcer healing, skin thickness, oesophagus function, lung involvement as assessed by lung function parameters FVC and DLCO, and side effects were measured. Conclusions. The efficacy of prolonged administration of iloprost is also achieved with low dose iloprost by long term treatment. The effects suggest a disease-modifying capability of iloprost, but further studies are needed to proof this hypothesis.
Phase:
Phase 2
Details
Lead Sponsor:
Charite University, Berlin, Germany
Collaborator:
Schering-Plough
Treatments:
Iloprost