NCT05137145

Brief Summary

Constipation is a common reason of poor bowel preparation, which negatively influences the quality of colonoscopy. Clinically to explore more effective and tolerant bowel clearance programs is necessary for patients with chronic constipation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

November 16, 2021

Last Update Submit

November 29, 2021

Conditions

Bowel Preparation

Keywords

Chronic ConstipationColonoscopyLinaclotide

Outcome Measures

Primary Outcomes (1)

  • The Boston Bowel Preparation Scale

    the effect of colon cleansing

    colonoscopy screening procedure

Study Arms (4)

The control group

EXPERIMENTAL

The control group was given 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestines

Drug: Compound Polyethylene Glycol Electrolyte Powder

the observation group 1

EXPERIMENTAL

the observation group 1 was given Linaclotide(290 ug) in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine

Drug: LinaclotideDrug: Compound Polyethylene Glycol Electrolyte Powder

the observation group 2

EXPERIMENTAL

the observation group 2 was given Linaclotide(290 ug) in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine

Drug: LinaclotideDrug: Compound Polyethylene Glycol Electrolyte Powder

the observation group 3

EXPERIMENTAL

the observation group 3 was given Linaclotide(290 ug) in 3 day combined with 3L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine.

Drug: LinaclotideDrug: Compound Polyethylene Glycol Electrolyte Powder

Interventions

LinaclotideDRUG

The observation group 1 was given Linaclotide in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine, and the observation group 2 was given Linaclotide in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine. observation group 3 was given Linaclotide in 3 day combined with 3L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine. Intestinal cleanliness and the incidence of adverse reactions of patients in each group were compared.

the observation group 1the observation group 2the observation group 3
Compound Polyethylene Glycol Electrolyte PowderDRUG

The control group was given Compound Polyethylene Glycol Electrolyte Powder to clear the intestines,

The control groupthe observation group 1the observation group 2the observation group 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, 710004, China

RECRUITING

Related Publications (1)

  • Wang L, Zhang Y, Li J, Ran Y, Wang X, Ma X, Yang Q, Wang F, Hu J, Zhuang K, Wang J, Quan X, Wang S, Meng R, Chen Y, Li X, Song Y, Han S, Hu H, Li L, Dai F. Efficacy of Polyethylene Glycol Electrolyte Powder Combined With Linaclotide for Colon Cleansing in Patients With Chronic Constipation Undergoing Colonoscopy: A Multicenter, Single-Blinded, Randomized Controlled Trial. Clin Transl Gastroenterol. 2024 Jun 1;15(6):e1. doi: 10.14309/ctg.0000000000000708.

    PMID: 38713137DERIVED

MeSH Terms

Interventions

linaclotide

Central Study Contacts

fei dai, MD

CONTACT

13772151298daifei68@hotmail.com

wang lianli

CONTACT

1573793976715737939767@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 30, 2021

Study Start

September 1, 2021

Primary Completion

March 31, 2022

Study Completion

April 30, 2022

Last Updated

November 30, 2021

Record last verified: 2021-11

Locations

CN(1)