Back to resultsStudy of Efficacy of a Vasopressin 2 Receptor Antagonist M0002 for Treatment of Ascites in Cirrhotic Subjects With Hypo- or Normonatraemia
Primary Purpose
Cirrhotic Ascites
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
M0002
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhotic Ascites
Eligibility Criteria
Main Inclusion Criteria:
- Subjects with any form of cirrhosis with ascites and who had at least 1 paracentesis of at least 4 liter in the last 6 months.
- Dose of diuretics of spironolactone and furosemide was to be stable for at least one week prior to the screening visit or subject was refractory to diuretics.
- Subjects had to have been on a salt restricted diet (< 5.2 grams sodium/day, 90 mmol) during the screening period prior to the trial drug administration.
- Other treatment for the management of cirrhosis and ascites should be stable for at least 2 weeks prior to trial drug administration.
- Child-Pugh B and C liver cirrhosis score lower than 12.
- Subjects with hyponatraemia with sodium level between 120 and 132 mmol/l or normonatraemia with sodium level between 133 and 145 mmol/l measured at screening visit and day 1.
Main Exclusion Criteria:
- Women of child bearing potential (WOCBP)
- Functional transjugular intrahepatic portasystemic stent shunt (TIPS), peritoneovenous shunt
- Liver transplantation
- Budd-Chiari syndrome
- Unstable hepatic disease (acute hepatitis, AST or ALT > 5 x upper limit of normal, bilirubin > 10 mg/dL)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
M0002
Placebo
Arm Description
Started at 0.3 mg/day and increased every 3 days (to 1, 3 and 6 mg/day) for hyponatraemic subjects: dose was increased until the evening serum level was between 132 mmol/l and 145 mmol/l; for normonatraemic subjects the dose was increased until a 500 ml increase in the 24-h urine volume compared with Day-1 was reached. Once the required response or max dose was achieved, subjects entered a maintenance phase where they remained on the same dose of M0002 or placebo until 15 days.
Outcomes
Primary Outcome Measures
Plasma sodium levels, weight, number of paracentesis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01179607
Brief Title
Study of Efficacy of a Vasopressin 2 Receptor Antagonist M0002 for Treatment of Ascites in Cirrhotic Subjects With Hypo- or Normonatraemia
Official Title
A Randomized, Double Blind, Placebo Controlled, Phase II, Dose-titration Trial to Explore the Safety, Tolerability, Pharmacokinetic Profile and Efficacy of M0002 in Cirrhotic Subjects With Ascites and Hypo- or Normonatraemia.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Movetis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
M0002, an orally active, selective non-peptidergic antagonist of the vasopressin V2 receptor inhibits vasopressin-induced water reabsorption from the kidney. Therefore the aquaretic effect of M0002 has a potential clinical benefit in the treatment of ascites and hyponatreamia in cirrhotic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhotic Ascites
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
M0002
Arm Type
Active Comparator
Arm Description
Started at 0.3 mg/day and increased every 3 days (to 1, 3 and 6 mg/day)
for hyponatraemic subjects: dose was increased until the evening serum level was between 132 mmol/l and 145 mmol/l;
for normonatraemic subjects the dose was increased until a 500 ml increase in the 24-h urine volume compared with Day-1 was reached.
Once the required response or max dose was achieved, subjects entered a maintenance phase where they remained on the same dose of M0002 or placebo until 15 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
M0002
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Plasma sodium levels, weight, number of paracentesis
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Subjects with any form of cirrhosis with ascites and who had at least 1 paracentesis of at least 4 liter in the last 6 months.
Dose of diuretics of spironolactone and furosemide was to be stable for at least one week prior to the screening visit or subject was refractory to diuretics.
Subjects had to have been on a salt restricted diet (< 5.2 grams sodium/day, 90 mmol) during the screening period prior to the trial drug administration.
Other treatment for the management of cirrhosis and ascites should be stable for at least 2 weeks prior to trial drug administration.
Child-Pugh B and C liver cirrhosis score lower than 12.
Subjects with hyponatraemia with sodium level between 120 and 132 mmol/l or normonatraemia with sodium level between 133 and 145 mmol/l measured at screening visit and day 1.
Main Exclusion Criteria:
Women of child bearing potential (WOCBP)
Functional transjugular intrahepatic portasystemic stent shunt (TIPS), peritoneovenous shunt
Liver transplantation
Budd-Chiari syndrome
Unstable hepatic disease (acute hepatitis, AST or ALT > 5 x upper limit of normal, bilirubin > 10 mg/dL)
12. IPD Sharing Statement
Learn more about this trial
Study of Efficacy of a Vasopressin 2 Receptor Antagonist M0002 for Treatment of Ascites in Cirrhotic Subjects With Hypo- or Normonatraemia
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