NCT05379491

Application of Linaclotide Capsule in Bowel Preparation for Patients at High Risk of Inadequate Bowel Preparation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 720 (actual)
• Sponsor: Zhiguo Liu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colonoscopy

Interventions

Type	Name	Description
DRUG	3 L PEG + linaclotide	Participants take a linaclotide capsule on the day before colonoscopy at least 30 minutes before the first meal (if this is impossible, take the capsule as early as possible on that day). Participants take 1 L polyethylene glycol electrolyte solution within 1 hour from 8 p.m the night before the examination and take another linaclotide capsule and 2 L polyethylene glycol electrolyte solution 4 hours before the colonoscopy.
DRUG	3 L PEG + placebo	Participants take a placebo capsule on the day before colonoscopy at least 30 minutes before the first meal (if this is impossible, take the capsule as early as possible on that day). Participants take 1 L polyethylene glycol electrolyte solution within 1 hour from 8 p.m the night before the examination and take another placebo capsule and 2 L polyethylene glycol electrolyte solution 4 hours before the colonoscopy.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-06-30
• Completion: 2023-07-15
• First posted: 2022-05-18
• Last updated: 2024-05-23

Locations

8 sites across 1 country: China