Study of Efficacy of a Vasopressin 2 Receptor Antagonist M0002 for Treatment of Ascites in Cirrhotic Subjects With Hypo- or Normonatraemia

This study has been completed.
Sponsor:
Information provided by:
Movetis
ClinicalTrials.gov Identifier:
NCT01179607
First received: August 10, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cirrhotic Ascites
Drug: M0002
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Further study details as provided by Movetis:

Primary Outcome Measures:
  • Plasma sodium levels, weight, number of paracentesis [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: June 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: M0002
  • 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.

Drug: M0002
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Other treatment for the management of cirrhosis and ascites should be stable for at least 2 weeks prior to trial drug administration.
  5. Child-Pugh B and C liver cirrhosis score lower than 12.
  6. 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:

  1. Women of child bearing potential (WOCBP)
  2. Functional transjugular intrahepatic portasystemic stent shunt (TIPS), peritoneovenous shunt
  3. Liver transplantation
  4. Budd-Chiari syndrome
  5. Unstable hepatic disease (acute hepatitis, AST or ALT > 5 x upper limit of normal, bilirubin > 10 mg/dL)
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Movetis
ClinicalTrials.gov Identifier: NCT01179607     History of Changes
Other Study ID Numbers: M0002-BEL-C201
Study First Received: August 10, 2010
Last Updated: August 10, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:
Ascites
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014