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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: |
NCT00501384 |
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Date of registration:
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13/07/2007 |
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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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Satavaptan Dose-Ranging Study in the Prevention of Ascites
SPA |
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Scientific title:
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Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites |
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Date of first enrolment:
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April 2004 |
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Target sample size:
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151 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00501384 |
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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: Double Blind (Subject, Investigator), 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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Argentina
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Australia
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Belgium
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Canada
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Croatia
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Czech Republic
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France
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Germany
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Italy
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Spain
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Taiwan
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Contacts
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Name:
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ICD CSD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical
evidence
- Patients having undergone therapeutic paracentesis for the removal of ascites in the
previous 24 hours with the removal of =4 L of fluid
- Patients having undergone at least 1 other therapeutic paracentesis in the previous 3
months
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ascites
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Liver Cirrhosis
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Intervention(s)
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Drug: satavaptan (SR121463B)
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Primary Outcome(s)
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Time to repeat therapeutic paracentesis
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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quality of life
[Time Frame: 12 weeks]
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Increase in ascites judged by body weight and ascites volume
[Time Frame: within 12 weeks]
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frequency of paracentesis
[Time Frame: 12 weeks]
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Secondary ID(s)
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DFI4522
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LTS10209
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LTS5635
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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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