Evaluation of Safety and Efficacity of Indometacin and Two Potassium Sparing Diuretics in Adult Patients Affected by Gitelman Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone
研究概览
简要总结
Gitelman syndrome is a rare renal disease where the kidneys are unable to normally retain some salts (sodium, potassium and magnesium). Main consequences of these renal leaks of salts are a tendency toward low blood pressure, hypokalemia and hypomagnesemia both contributing to cardiac and muscles symptoms.
详细描述
Patients with received in random order 75mg/day indometacin (Chronoindocid®), 10-20 mg/day amiloride and 50-150 mg /day eplerenone (Inspra ®). The three 6 weeks-periods of treatment will be followed by six weeks washout period. 3-6 weeks before the first period of treatment, a supplementation with potassium and magnesium will be orally given, and maintained at the same dose throughout the study and stoped 6 weeks after the end of the third period of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients 18-60 yrs old, both sex, with genetically proven Gitelman's syndrome, under birth pill control for woman.
排除标准
- •counter-indication to treatment under study
- •Other diuretic or NAIS treatments than amiloride, spironolactone, or indometacin
研究组 & 干预措施
Amiloride, Indometacin, Eplerenone
Amiloride, indometacin(+Omeprazole), Eplerenone
干预措施: TREATMENT (Drug)
Amiloride, Eplerenone, indometacin
Amiloride, Eplerenone, indometacin (+Omeprazole)
干预措施: TREATMENT (Drug)
Eplerenone, Amiloride, indometacin
Eplerenone, Amiloride, indometacin (+Omeprazole)
干预措施: TREATMENT (Drug)
Eplerenone, Indometacin, Amiloride
Eplerenone, Indometacin, Amiloride
干预措施: TREATMENT (Drug)
Indometacin, Eplerenone, Amiloride
Indometacin, Eplerenone, Amiloride
干预措施: TREATMENT (Drug)
Indometacin, Amiloride, Eplerenone
Indometacin, Amiloride, Eplerenone
干预措施: TREATMENT (Drug)
结局指标
主要结局
To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone
时间窗: 2 months
次要结局
- To evaluate the effectiveness of indomethacin on disorders possibly induced by chronic hypokalemia and /or hypomagnesemia (EKG, lipid disorders related to insulin resistance, glucose/ insulin ratio)(2 months)
- To evaluate the effectiveness of eplerenone and amiloride on hypokalemia.(2 months)
- To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders(2 months)