NCT01179607已完成2 期
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.
Movetis0 个研究点目标入组 15 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- Plasma sodium levels, weight, number of paracentesis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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)
研究组 & 干预措施
M0002
Active Comparator
- 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.
干预措施: M0002 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Plasma sodium levels, weight, number of paracentesis
时间窗: 15 days
次要结局
未报告次要终点
研究者
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