AscitesPhase 2Normo~CATNCT00501566
Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites
A Phase 2 study testing satavaptan (SR121463B) in people with Ascites and Liver Cirrhosis, run by Sanofi at 12 sites in 12 countries.
Trial summary
The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites, Liver Cirrhosis
- What is being tested?
- satavaptan (SR121463B)
- How many people
- 148 participants
- Where
- 12 sitesin 12 countries
- Study dates
- Apr 2004to Jan 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
- Moderate or tense ascites
- Serum sodium of >130 mmol/l.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Who cannot join
None listed.
Trial locations and contacts
12 sites in 12 countries.
12 sites in 12 countries
About this study
Official title: SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study
The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide.
The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.
- Conditions
- Ascites, Liver Cirrhosis
- Being tested
- satavaptan (SR121463B)
- Keywords
- cirrhotic ascites
- Medical subject headings
- Ascites, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
satavaptan (SR121463B)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: within 14 days
Secondary outcomes (3)
Abdominal girth and discomfort
Measured: 14 days
Paracentesis
Measured: 14 days
Quality of life
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startApr 2004
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501566
- Sponsor's protocol ID
- DFI5563
- Other IDs
- SR121463
- Acronym
- Normo~CAT
- Status last verified
- Jul 2007
- First submitted
- 13 Jul 2007
- Last updated
- 16 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study
- ClinicalTrials.gov ID
- NCT00501566
- Acronym / sponsor ID
- Normo~CAT / DFI5563
- Conditions
- Ascites, Liver Cirrhosis
- Keywords
- cirrhotic ascites
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Jan 2005 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide.
The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
- Moderate or tense ascites
- Serum sodium of >130 mmol/l.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| satavaptan (SR121463B) | Drug | – |
Primary outcome
Change in body weight
Time frame: within 14 days
3 secondary outcomes
Abdominal girth and discomfort
Time frame: 14 days
Paracentesis
Time frame: 14 days
Quality of life
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2007.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing satavaptan (SR121463B) in people with Ascites and Liver Cirrhosis, run by Sanofi at 12 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Argentina, Australia, Belgium, Canada, Croatia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: within 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2007.