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Offene, monozentrische, randomisierte, placebo-kontrollierte, einfach blinde und Observer-blinde klinische Studie bei PatientInnen mit Raynaud Syndrom mit / ohne progressiver systemischer Sklerodermie zur systemischen Therapie mit Iloprost versus Placebo - iloprost in raynaud

Offene, monozentrische, randomisierte, placebo-kontrollierte, einfach blinde und Observer-blinde klinische Studie bei PatientInnen mit Raynaud Syndrom mit / ohne progressiver systemischer Sklerodermie zur systemischen Therapie mit Iloprost versus Placebo - iloprost in raynaud

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-000905-41-AT
Enrollment
Unknown
Registered
2006-05-08
Start date
2006-06-07
Completion date
Unknown
Last updated
2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Raynaud syndrome with / without systemic sclerosis

Interventions

Trade Name: Ilomedin Product Name: Ilomedin Product Code: 1-22460 Pharmaceutical Form: Intravenous infusion Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the plac

Sponsors

ao. Univ. Prof. Dr. Elisabeth Aberer
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with Raynaud syndrome with / without scleroderma, Iloprost treatment since >1 month Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Abnormal hemostasis, diabetes, pregnancy, breast feeding, coronary heart disease

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the action of Iloprost on the number, severity and duration of Raynaud attacks in comparison to placebo in patients with Raynaud syndrome with / without scleroderma. ;Secondary Objective: Measuring skin temperature before and after infusion of iloprost or placebo.;Primary end point(s): Number, duration and severity of Raynaud attacks after treatment with Iloprost or placebo for 5 months.

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026