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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05379491
• Other study ID #: KY20222119-F-1
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: July 15, 2023

Study information

• Verified date: May 2024
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: July 15, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• scheduled for colonoscopy

• age = 18

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Linfen Central Hospital	Linfen	Shanxi
China	The Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Air Force 986 Hospital	Xi'an	Shaanxi
China	Shaanxi Provincial People's Hospital	Xi'an	Shaanxi
China	Xi'an Central Hospital	Xi'an	Shaanxi
China	Xi'an Jiaotong University Second Affiliated Hospital	Xi'an	Shaanxi
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi
China	Ningxia Hui Autonomous Region People's Hospital	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
Zhiguo Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel preparation adequate rate	The rate of participants with all colon segment scores (proximal colon, transverse colon, distal colon) are = 2 according to Boston Bowel Preparation Scale.	48 hours
Primary	Number of adenomas per patient	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.	48 hours
Secondary	Subject willingness to repeat the preparation	Survey	1 Day of colonoscopy
Secondary	Tolerance to bowel preparation	It will be subjective and assessed as non, mild, moderate, severe.	1 Day of colonoscopy
Secondary	Tolerance to colonoscopy	It will be subjective and assessed as non, mild, moderate, severe.	1 Day of colonoscopy
Secondary	Average number of polyps per patient	Average number of polyps detected per patient by colonoscopy in each arm	1 Day of colonoscopy
Secondary	Average number of adenomas per patient	Average number of adenomas detected per patient by colonoscopy in each arm	1 Day of colonoscopy
Secondary	Withdrawal time	the time from cecal identification to the withdrawal of the colonoscopy across the anus minus the time of polypectomy.	1Day of colonoscopy
Secondary	Cecal intubation rate for colonoscopies	Cecal intubation was defined as reaching the ileocecal valve	1 Day of colonoscopy