Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis (ILODOSE)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Systemic Sclerosis |
Drug: iloprost Drug: iloprost low dose Drug: iloprost therapy up to 2 ng/kg x min |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparision Between Maximally Tolerated Intravenous Iloprost Doses Versus Low-Dosed Iloprost for a 21-Day Treatment Course |
- Healing of digital ulcers [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
- Duration of RP [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Frequency of RP [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- changes in lung function [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- changes in MRSS [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- subjective improvement of esophagus function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- subjective benefit from iloprost therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- side effecs [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 50 |
| Study Start Date: | September 1997 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
low dose iloprost therapy 0.5 ng/kg x min
|
Drug: iloprost low dose
0.5 ng/kg x min over 6 h per day for 21 consecutive days
Other Name: intravenous ilomedin
Drug: 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
Other Name: ilomedin treatment
|
|
Active Comparator: B
high-dose therapy
|
Drug: iloprost
0.5-2 ng/kg x min for 6hours a day for 21 consecutive days
Other Name: intravenous ilomedin
Drug: 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
Other Name: ilomedin treatment
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Germany | |
| Charrité Universitätsmedizin | |
| Berlin, Germany, 10117 | |
| Principal Investigator: | Gabriela Riemekasten, MD | Charite University, Berlin, Germany |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Riemekasten, PD Dr. med., Cahrité Universitätsmedizin |
| ClinicalTrials.gov Identifier: | NCT00622687 History of Changes |
| Other Study ID Numbers: | ILO-1998, Schering GmbH |
| Study First Received: | February 14, 2008 |
| Last Updated: | February 22, 2008 |
| Health Authority: | Germany: Federal Ministry of Education and Research |
Keywords provided by Charite University, Berlin, Germany:
|
iloprost systemic sclerosis digital ulcers observational study randomized |
Additional relevant MeSH terms:
|
Scleroderma, Systemic Scleroderma, Diffuse Sclerosis Connective Tissue Diseases Skin Diseases Pathologic Processes Iloprost |
Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Vasodilator Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013