Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
试验速览
- 阶段
- 3 期
- 入组人数
- 184
- 试验地点
- 3
- 主要终点
- Change of number of bowel movements at 1 week
研究概览
简要总结
The aim of this study is to determine the efficacy and safety of PEG 3350 (polyethylene glycol 3350) for short-term treatment of chronic constipation in adults.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged ≥ 18 years.
- •Body Mass Index (BMI) ≥ 18.5
- •Organic bowel disease will be ruled out by Fecal Immunochemical Test (FIT) and/or colonoscopy.
- •Must have ≤ 2 bowel movements during a 7-day qualification period.
- •In otherwise good health as judged by a physical examination and laboratory testing.
- •Not taking medications known to affect bowel function in one week before study.
- •Willing to participate in the study by signing the informed consent.
排除标准
- •Hypersensitive to the study medication.
- •obstructive ileus.
- •Irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD)
研究组 & 干预措施
Lactulax
15 ml of Lactulax syrup (containing 10 g of lactulose) is drunk with 240 ml of water once daily at bedtime, for a duration of 14 days
干预措施: Lactulose (Drug)
PEG 3350
The content of each sachet of PEG 3350 (17 g powder) is dissolved in 240 mL of water, drink it once daily at bedtime, for a duration of 14 days.
干预措施: PEG 3350 (Drug)
结局指标
主要结局
Change of number of bowel movements at 1 week
时间窗: 7 days
An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.
Change of number of bowel movements at 2 weeks
时间窗: 14 days
An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.
次要结局
- Symptom scores at 1 week(7 days)
- Symptom scores at 2 weeks(14 days)
- Overall rating of effectiveness at 1 week(7 days)
- Overall rating of effectiveness at 2 weeks(14 days)
研究者
Murdani Abdullah
Professor
Fakultas Kedokteran Universitas Indonesia