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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00622687
Other study ID # ILO-1998
Secondary ID Schering GmbH
Status Terminated
Phase Phase 2
First received February 14, 2008
Last updated February 22, 2008
Start date September 1997
Est. completion date December 2007

Study information

Verified date December 2007
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Ministry of Education and Research
Study type Interventional

Clinical Trial 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.


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 Raynaud`s phenomenon were included into the study after written informed consent to participate in this study. Severe Raynaud`s 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.


Recruitment information / eligibility

Status Terminated
Enrollment 50
Est. completion date December 2007
Est. primary completion date December 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
iloprost
0.5-2 ng/kg x min for 6hours a day for 21 consecutive days
iloprost low dose
0.5 ng/kg x min over 6 h per day for 21 consecutive days
iloprost therapy up to 2 ng/kg x min
starting therapy at doses of 0.5 ng/kg x min, increase the dose every two days for 0.5 ng/kg x min up to the maximally tolerated dose or to 2 ng/kg x min

Locations

Country Name City State
Germany Charrité Universitätsmedizin Berlin

Sponsors (2)

Lead Sponsor Collaborator
Charite University, Berlin, Germany Schering-Plough

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Riemekasten G, Jepsen H, Burmester GR, Hiepe F. [Iloprost administration over 21 days as an effective therapy in systemic scleroderma--case report and review of the literature]. Z Rheumatol. 1998 Apr;57(2):118-24. Review. German. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Healing of digital ulcers 5 weeks No
Secondary Duration of RP 6 weeks No
Secondary Frequency of RP 6 weeks No
Secondary changes in lung function 4 years No
Secondary changes in MRSS 6 years No
Secondary subjective improvement of esophagus function 1 year No
Secondary subjective benefit from iloprost therapy 1 year No
Secondary side effecs 6 weeks Yes
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