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Main
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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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00622687 |
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Date of registration:
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14/02/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis
ILODOSE |
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Scientific title:
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Comparision Between Maximally Tolerated Intravenous Iloprost Doses Versus Low-Dosed Iloprost for a 21-Day Treatment Course |
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Date of first enrolment:
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September 1997 |
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Target sample size:
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50 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00622687 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Germany
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Contacts
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Name:
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Gabriela Riemekasten, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Charite University, Berlin, Germany |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Sclerosis
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Intervention(s)
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Drug: iloprost low dose
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Drug: iloprost therapy up to 2 ng/kg x min
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Drug: iloprost
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Primary Outcome(s)
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Healing of digital ulcers
[Time Frame: 5 weeks]
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Secondary Outcome(s)
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side effecs
[Time Frame: 6 weeks]
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Frequency of RP
[Time Frame: 6 weeks]
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changes in lung function
[Time Frame: 4 years]
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Duration of RP
[Time Frame: 6 weeks]
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subjective improvement of esophagus function
[Time Frame: 1 year]
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subjective benefit from iloprost therapy
[Time Frame: 1 year]
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changes in MRSS
[Time Frame: 6 years]
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Secondary ID(s)
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Schering GmbH
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ILO-1998
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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URL:
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