A Randomized, Controlled, Parallel Group, Assessor-Blinded Study To Compare The Efficacy, Tolerability, And Safety Of Oral Sodium Picosulfate (PicoPrep®) Versus Oral Mannitol and Bisacodyl, For Colon Cleansing In Colonoscopy Preparation Of Adult Outpatients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Percentage of subjects classified as success (Aronchick scale)
研究概览
简要总结
This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
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
- •Men or women aged 18 to 60 years
- •Subjects scheduled for an elective colonoscopy
- •Women of child-bearing potential using at least one highly effective contraceptive method
- •Subjects able to understand all instructions
- •Informed consent signed
排除标准
- •Hypersensitivity to active ingredients
- •Female participants pregnant or with a positive blood pregnancy test
- •Acute surgical abdomen
- •Previous colorectal surgery
- •Gastrointestinal (GI) surgery
- •GI diseases, active inflammatory bowel disease, colon disease
- •Ascites/hepatic cirrhosis, cardiac disease, advanced pulmonary or renal disease
- •Use of laxatives or antidiarrheal agents 72 hours prior to screening
- •Significant alterations in laboratory values or other diseases that could interfere with the results
研究组 & 干预措施
Picoprep
sodium picosulfate, magnesium oxide and citric acid
干预措施: sodium picosulfate, magnesium oxide and citric acid (Picoprep®) (Drug)
Mannitol and Bisacodyl
干预措施: mannitol (Drug)
Mannitol and Bisacodyl
干预措施: Bisacodyl (Drug)
结局指标
主要结局
Percentage of subjects classified as success (Aronchick scale)
时间窗: At visit 2 (day 1 of colonoscopy)
Defined as excellent or good according to the Aronchick scale
次要结局
- Percentage of subjects classified as success (Ottawa scale)(At visit 2 (day 1 of colonoscopy))
- Subject satisfaction (Likert scale)(At visit 2 (day 1 of colonoscopy))
- Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire)(At visit 2 (day 1 of colonoscopy))