Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis (ILODOSE)

This study has been terminated.
(sufficient number to reach the primary endpoint and as planned)
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00622687
First received: February 14, 2008
Last updated: February 22, 2008
Last verified: December 2007
  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

Resource links provided by NLM:


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
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
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
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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 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 July 26, 2014