Evaluation of the efficacy and safety of the potassium citrate tablet of immediate release vs Acalka® of prolonged release in the treatment of urolithiasis in adults. Phase IIIa / IIIb - EESCPTAUA

Oriente Pharmaceutical Laboratory Company0 个研究点开始时间: 2020年9月9日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment

•1- Adults (19-75 years, both inclusive).
•2- Patients who have given their informed consent to participate in the study.
•3- Patients who present in the urine metabolic study any of the metabolic alterations of hypercalciuria, hyperuricosuria, hyperoxaluria, hypocitraturia or cystinuria.
•4- Patients who comply with the washout period (do not take any urinary alkalinizing medication) of 10 days or more, before recruitment.

•1- Patients with struvite stones.
•2- Patients with urinary infection.
•3- Patients with a history of hyperkalemia or at risk of it (glomerular filtration rate less than 25 ml / min x 1.73 m2SC).
•4- Patients with metabolic alkalosis (HCO3- in plasma greater than 33mEq / l).
•5- Patients with a history of gastritis or active peptic ulcer, with delayed gastric emptying, with esophageal compression, obstruction or intestinal stricture.
•6- Patients who are taking anticholinergic medications.
•7- Patients who present any mental or physical condition that prevents them from collecting 24-hour urine.
•8- Pregnant and postpartum patients who are breastfeeding.
•9- Diabetic patients decompensated from the disease.
•10- Patients who are taking potassium-sparing diuretics.

发起方

Oriente Pharmaceutical Laboratory Company