An Efficacy and Safety Evaluation of Linaclotide in Bowel Preparation by Patients at High Risk of Inadequate Bowel Preparation: a Multicenter, Randomized, Double-Blind, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 720
- 试验地点
- 8
- 主要终点
- Bowel preparation adequate rate
研究概览
简要总结
The purpose of this study is to compare the colon cleansing quality of linaclotide versus control in adult patients at high risk of inadequate bowel preparation: one group will receive polyethylene glycol solution (PEG) split dose (1 L + 2 L) plus linaclotide and the other group PEG (1 L + 2 L) plus placebo before colonoscopy.
详细描述
The objective of this trial is to compare the colon cleanliness achieved with PEG split dose (1 L + 2 L) + linaclotide versus PEG split dose (1 L + 2 L) + placebo for patients scheduled for a colonoscopy at high risk of inadequate bowel preparation. The target patients are those with constipation, poor bowel preparation history, history of abdominal/pelvic surgery, comorbidity (diabetes, Parkinson's disease, stroke, or history of spinal cord injury), BMI > 25 kg/m2, age > 70, tricyclic antidepressants usage, or opioid usage, as defined by the latest version of Bowel Preparation Guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A randomized grouping sequence by block randomization with a block size of 4 is generated using a web-based service. Linaclotide or placebo is allocated according to the sequence and labelled in numerial order (1 - 720) without labelling the allocation information. Therefore, patients, endoscopists, and other investigators at each center will be unaware of the drug allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for colonoscopy
- •meet any of the followings: functional constipation according to Rome IV criteria, poor bowel preparation history, BMI > 25 kg/m2, age > 70, history of abdominal/pelvic surgery, comorbidity (diabetes, Parkinson's disease, stroke, or history of spinal cord injury), antidepressant usage, opioid usage
- •willing to provide informed consent
排除标准
- •unable to cooperate with questionnaires
- •uncontrolled hypertension (systolic .170 mm Hg and diastolic.100mmHg)
- •pregnancy or lactation
- •toxic colitis, or megacolon
- •allergy to preparation components
- •active inflammatory bowel disease
- •clinically significant electrolyte abnormalities
- •a history of severe renal, liver, or cardiac insufficiency
- •has already been enrolled in the study
- •gastrointestinal obstruction
- •obvious gastroparesis or gastric retention
- •bowel perforation
- •polyp syndrome
- •history of colectomy
- •any other condition that is inappropriate for enrollment as judged by the investigator.
研究组 & 干预措施
3 L PEG + Linaclotide
Bowel preparation for colonoscopy was performed with 3 L polyethylene glycol solution combined with 2-day linaclotide.
干预措施: 3 L PEG + linaclotide (Drug)
3 L PEG + Placebo
Bowel preparation for colonoscopy was performed with 3 L polyethylene glycol solution combined with 2-day placebo.
干预措施: 3 L PEG + placebo (Drug)
结局指标
主要结局
Bowel preparation adequate rate
时间窗: 48 hours
The rate of participants with all colon segment scores (proximal colon, transverse colon, distal colon) are ≥ 2 according to Boston Bowel Preparation Scale.
Number of adenomas per patient
时间窗: 48 hours
If there is no significant difference in the first primary outcome between the two groups, compare the average number of adenomas per patient detected by colonoscopy.
次要结局
- Subject willingness to repeat the preparation(1 Day of colonoscopy)
- Tolerance to bowel preparation(1 Day of colonoscopy)
- Tolerance to colonoscopy(1 Day of colonoscopy)
- Average number of polyps per patient(1 Day of colonoscopy)
- Average number of adenomas per patient(1 Day of colonoscopy)
- Withdrawal time(1Day of colonoscopy)
- Cecal intubation rate for colonoscopies(1 Day of colonoscopy)
研究者
Zhiguo Liu
Associate Professor
Xijing Hospital of Digestive Diseases