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Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis

NCT00622687 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2008-02-25

No results posted yet for this 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.

Conditions

Interventions

DRUG

iloprost

0.5-2 ng/kg x min for 6hours a day for 21 consecutive days

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

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Gabriela Riemekasten, MD · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-09-30
Primary Completion
2003-12-31
Completion
2007-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00622687 on ClinicalTrials.gov