[Translation] A multicenter, randomized, single-blind, active-controlled phase III clinical study to evaluate the efficacy and safety of compound sodium sulfate tablets in bowel preparation in Chinese adults
本研究的目的是比较复方硫酸钠片和复方聚乙二醇电解质散Ⅲ(福静清)作为成人结肠镜检查前分剂量肠道准备方案的有效性和安全性。
(1)主要目的
通过结肠镜检查验证复方硫酸钠片用于成人肠道准备的成功率非劣于复方聚乙二醇电解质散Ⅲ(福静清)。
(2)次要目的
比较复方硫酸钠片和复方聚乙二醇电解质散Ⅲ(福静清)用于成人肠道准备的有效性、安全性及受试者耐受度和满意度。
[Translation] The purpose of this study is to compare the effectiveness and safety of compound sodium sulfate tablets and compound polyethylene glycol electrolyte powder III (Fujingqing) as split-dose bowel preparation regimens for adults before colonoscopy.
(1) Primary purpose
To verify that the success rate of compound sodium sulfate tablets for bowel preparation in adults is non-inferior to that of compound polyethylene glycol electrolyte powder III (Fujingqing) through colonoscopy.
(2) Secondary purpose
To compare the effectiveness, safety, tolerance and satisfaction of subjects of compound sodium sulfate tablets and compound polyethylene glycol electrolyte powder III (Fujingqing) for bowel preparation in adults.