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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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7 November 2016 |
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Main ID: |
EUCTR2006-000905-41-AT |
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Date of registration:
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08/05/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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07/06/2006 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000905-41 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: yes
Double blind:
Parallel group:
Cross over:
Other: yes
Other trial design description: observer blind
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Austria
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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:
Abnormal hemostasis, diabetes, pregnancy, breast feeding, coronary heart disease
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Raynaud syndrome with / without systemic sclerosis
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Intervention(s)
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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 placebo: Intravenous use
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Primary Outcome(s)
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Primary end point(s): Number, duration and severity of Raynaud attacks after treatment with Iloprost or placebo for 5 months.
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Secondary Objective: Measuring skin temperature before and after infusion of iloprost or placebo.
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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.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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