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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Terminated
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
Primary:

To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in
reducing the recurrence of ascites.

Secondary:

To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic
drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent
ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term
safety study (PASCCAL-2).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00366795
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00366795