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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01179607
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : August 11, 2010
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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.

Condition or disease Intervention/treatment Phase
Cirrhotic Ascites Drug: M0002 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : June 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Plasma sodium levels, weight, number of paracentesis [ Time Frame: 15 days ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Responsible Party: Movetis Identifier: NCT01179607     History of Changes
Other Study ID Numbers: M0002-BEL-C201
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Pathologic Processes