Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00366795




Registration number
NCT00366795
Ethics application status
Date submitted
18/08/2006
Date registered
21/08/2006
Date last updated
18/05/2016

Titles & IDs
Public title
Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver
Scientific title
Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo in the Absence of Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.
Secondary ID [1] 0 0
EudraCT : 2006-000132-27
Secondary ID [2] 0 0
EFC6682
Universal Trial Number (UTN)
Trial acronym
SPARe-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ascites 0 0
Liver Cirrhosis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Satavaptan
Treatment: Drugs - placebo

Experimental: Satavaptan -

Placebo comparator: Placebo -


Treatment: Drugs: Satavaptan
oral administration once daily

Treatment: Drugs: placebo
oral administration once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and time of recurrences of therapeutic paracenteses
Timepoint [1] 0 0
up to 12 weeks
Secondary outcome [1] 0 0
Time from randomisation to first recurrence of ascites
Timepoint [1] 0 0
study period
Secondary outcome [2] 0 0
Increase in ascites
Timepoint [2] 0 0
over 12 weeks

Eligibility
Key inclusion criteria
* Patients with cirrhosis of the liver.
* Patients resistant to the effects of diuretics, intolerant of diuretics or otherwise unsuitable for treatment with diuretics according to the judgement of the investigator.
* Patients with recurrent ascites having undergone both of the following:

* therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of = or > 4 litres of fluid.
* at least one other therapeutic paracentesis in the previous 3 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt.
* Known hepatocellular carcinoma.
* Patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
* Patients previously exposed to satavaptan in the past 12 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
241
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
Argentina
State/province [2] 0 0
San Isidro
Country [3] 0 0
Belgium
State/province [3] 0 0
Diegem
Country [4] 0 0
Bosnia and Herzegovina
State/province [4] 0 0
Sarajevo
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Sofia
Country [7] 0 0
Canada
State/province [7] 0 0
Laval
Country [8] 0 0
Chile
State/province [8] 0 0
Santiago
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Praha
Country [10] 0 0
France
State/province [10] 0 0
Paris
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Malaysia
State/province [12] 0 0
Kuala Lumpur
Country [13] 0 0
Mexico
State/province [13] 0 0
Mexico
Country [14] 0 0
Poland
State/province [14] 0 0
Warszawa
Country [15] 0 0
Romania
State/province [15] 0 0
Bucuresti
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Moscow
Country [17] 0 0
Serbia
State/province [17] 0 0
Belgrade
Country [18] 0 0
Singapore
State/province [18] 0 0
Singapore
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Turkey
State/province [20] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00366795