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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/NCT00501384




Registration number
NCT00501384
Ethics application status
Date submitted
13/07/2007
Date registered
16/07/2007
Date last updated
12/01/2009

Titles & IDs
Public title
Satavaptan Dose-Ranging Study in the Prevention of Ascites
Scientific title
Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites
Secondary ID [1] 0 0
LTS5635
Secondary ID [2] 0 0
DFI4522
Universal Trial Number (UTN)
Trial acronym
SPA
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - satavaptan (SR121463B)

Treatment: Drugs: satavaptan (SR121463B)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to repeat therapeutic paracentesis
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Increase in ascites judged by body weight and ascites volume
Timepoint [1] 0 0
within 12 weeks
Secondary outcome [2] 0 0
frequency of paracentesis
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
quality of life
Timepoint [3] 0 0
12 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2005
Sample size
Target
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Cove
Recruitment postcode(s) [1] 0 0
- Cove
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Belgium
State/province [2] 0 0
Diegem
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Croatia
State/province [4] 0 0
Zagreb
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Praha
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Italy
State/province [8] 0 0
Milano
Country [9] 0 0
Spain
State/province [9] 0 0
Barcelona
Country [10] 0 0
Taiwan
State/province [10] 0 0
Taipei

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective is to determine the optimal dose or range of doses of SR121463B for the
reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of
spironolactone.

The secondary objective was to determine the tolerability of different fixed doses of
SR121463B in cirrhotic ascites, over a 12-week treatment period.

This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety
extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00501384
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/NCT00501384