NCT01603654已完成4 期
A Randomized Controlled Trial Comparing the Efficacy and Acceptability of Sodium Picosulphate/Magnesium Citrate With Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Efficacy of bowel cleansing
研究概览
简要总结
Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon preparation affects the quality of colon cleansing. The study is aimed at comparing the efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing, and to identify predictors of poor bowel preparation.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult outpatients
- •aged 18-85 years
- •undergoing elective colonoscopy
排除标准
- •previous colon resection
- •intestinal obstruction
- •toxic megacolon
- •severe heart failure (New York Heart Association [NYHA] Class III or IV)
- •acute cardiovascular disease
- •uncontrolled arterial hypertension (systolic pressure > 170 mmHg, diastolic pressure > 100 mmHg)
- •severe liver failure or ascites
- •end-stage renal failure
- •phenylketonuria
- •glucose-6-phosphate dehydrogenase deficiency. Women were excluded from the study if they were pregnant, breastfeeding
研究组 & 干预措施
sodium picosulphate/magnesium citrate
Experimental
干预措施: sodium picosulphate magnesium citrate (Drug)
low-volume PEG -ascorbic acid
Active Comparator
干预措施: low-volume PEG -ascorbic acid (Drug)
结局指标
主要结局
Efficacy of bowel cleansing
时间窗: Within 24 hrs
Assessment of quality of colon cleansing at colonoscopy as achieved by the two study products
次要结局
- Safety(In the 24 hours within assumption of study products)
- Tolerability(Within 12 hrs)
研究者
Dr Gianpiero Manes, MD
Principal investigator
ASST Fatebenefratelli Sacco
研究点 (3)
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