Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis

Last updated: February 22, 2008
Sponsor: Charite University, Berlin, Germany
Overall Status: Terminated

Phase

2

Condition

Scar Tissue

Scleroderma

Collagen Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT00622687
ILO-1998
Schering GmbH
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients with secondary Raynauds phenomenon suffering from severe Raynaud-sphenomenon with trophical changes or from digital ulcers with written informedconsent. Patients had to be stable for their systemic disease and were on stablemedication concerning immunosuppression or vasoactive therapies for three months.

Exclusion

Exclusion Criteria:

  • Current smokers, patients with a history of gastric ulcers in the last three months, acardiac ejection fraction below 25%, patients with severe organ involvement or otheruncontrolled diseases such as instable angina pectoris, severe anaemia,coagulopathies, azothaemia, cerebral stroke in the last 6 months or malignant diseaseswere excluded from the study. The last iloprost therapy had to be finished at least 6months ago. Participation in other studies during the last 4 weeks was also notallowed. For fertile women, a negative pregnancy test was required.

Study Design

Total Participants: 50
Study Start date:
September 01, 1997
Estimated Completion Date:
December 31, 2007

Study 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 Raynauds phenomenon were included into the study after written informed consent to participate in this study. Severe Raynauds phenomenon was defined by a high burden of disease, by trophic skin changes, or the presence of digital ulcers.

Patients suffering from SSc related RP and/or digital ulceration were randomized 1 : 1 to one of the following groups that received either high or low dose infusions of iloprost for 21 consecutive days given once or twice a year. High dose patients (n=25) started on 0.5ng per kg bw and min over 6 hours a day. Depending on the tolerability the dosages were increased in increments gradually every two days for 0.5 ng/kg x min. The maximum dose administered was 2.0ng/kg bw and min. Low dose patients (n=25) were permanently treated with 0.5ng/kg bw over 6 hours per day for 21 consecutive days.

Connect with a study center

  • Charrité Universitätsmedizin

    Berlin, 10117
    Germany

    Site Not Available

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