Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis - Full Text View

Sponsors and Collaborators:	Charite University, Berlin, Germany Schering-Plough
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00622687

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Comparision Between Maximally Tolerated Intravenous Iloprost Doses Versus Low-Dosed Iloprost for a 21-Day Treatment Course

Resource links provided by NLM:

MedlinePlus related topics: Scleroderma

Drug Information available for: Iloprost

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

Healing of digital ulcers [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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
A: Active Comparator 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 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
B: Active Comparator high-dose therapy	Drug: iloprost 0.5-2 ng/kg x min for 6hours a day for 21 consecutive days 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

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622687

Locations

Germany
Charrité Universitätsmedizin
Berlin, Germany, 10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Schering-Plough

Investigators

Principal Investigator:

Gabriela Riemekasten, MD

Charité Universitätsmedizin Berlin

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Kawald A, Burmester GR, Huscher D, Sunderkötter C, Riemekasten G. Low versus high-dose iloprost therapy over 21 days in patients with secondary Raynaud's phenomenon and systemic sclerosis: a randomized, open, single-center study. J Rheumatol. 2008 Sep;35(9):1830-7. Epub 2008 Jul 15.

Responsible Party:	Cahrité Universitätsmedizin ( Riemekasten, PD Dr. med. )
Study ID Numbers:	ILO-1998, Schering GmbH
Study First Received:	February 14, 2008
Last Updated:	February 22, 2008
ClinicalTrials.gov Identifier:	NCT00622687 History of Changes
Health Authority:	Germany: Federal Ministry of Education and Research

Keywords provided by Charite University, Berlin, Germany:

iloprost
systemic sclerosis
digital ulcers
observational study
randomized

Study placed in the following topic categories:

Iloprost
Vasodilator Agents
Skin Diseases
Ulcer
Connective Tissue Diseases
Scleroderma

Scleroderma, Diffuse
Platelet Aggregation Inhibitors
Sclerosis
Scleroderma, Systemic
Cardiovascular Agents

Additional relevant MeSH terms:

Vasodilator Agents
Skin Diseases
Hematologic Agents
Sclerosis
Cardiovascular Agents
Pharmacologic Actions
Iloprost

Pathologic Processes
Therapeutic Uses
Connective Tissue Diseases
Scleroderma, Diffuse
Scleroderma, Systemic
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 03, 2009