Evaluate the Safety of Linaclotide in IBS-C Patients in China

Irritable Bowel Syndrome-IBS Clinical Trial

— Liberty  

Official title:

Multi-center, Single Arm, Observational Study to Evaluate the Safety of Linaclotide in IBS-C Patients in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04462900
• Other study ID #: D5630R00001
• Status: Completed
• Start date: September 18, 2020
• Est. completion date: February 3, 2023

Study information

• Verified date: February 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a Multi-center, single arm, observational study to evaluate the safety of linaclotide in IBS-C patients in China. Enrolls approximately 3,000 Chinese patients from 30 participating sites around China and followed up for half year.

Description:

This is a multi-center, one arm, prospective observational study which enrolls approximately 3,000 Chinese patients in China.The study will be performed under real world clinical practice setting. Patients will be eligible for the study after taking at least one dose of linaclotide. Every patient will be followed maximum of 6 months after enrollment. Study measures will be collected at baseline and during the follow-up period. Incidence of adverse events will be employed to assess the safety and tolerability of linaclotide in Chinese patients. The treatment satisfaction will be employed to assess the impact of treatment. The Irritable Bowel Syndrome-Quality of Life Measure (IBS-QoL) will be employed to assess the patient's quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3017
• Est. completion date: February 3, 2023
• Est. primary completion date: February 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ? 18 years old
• Provision of subject informed consent prior to any study procedures
• Has taken at least one dose of linaclotide
• NOT participating in any interventional study currently or during the last 3 months

Exclusion Criteria:

• If linaclotide is contraindicated according to the product prescribing information
• Being unable to comply with study-specified procedure
• Has ever participated in current study before -

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Irritable Bowel Syndrome-IBS

Locations

Country	Name	City	State
China	Research Site	Baotou
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Binzhou
China	Research Site	Chengdu
China	Research Site	Chongqing
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Jinan
China	Research Site	Leshan
China	Research Site	Nanchang
China	Research Site	Nanjing
China	Research Site	Nanjing
China	Research Site	Qingdao
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shenyang
China	Research Site	Shenzhen
China	Research Site	Shenzhen
China	Research Site	Suzhou
China	Research Site	Taiyuan
China	Research Site	Tianjin
China	Research Site	Wenzhou
China	Research Site	Wuhan
China	Research Site	Wulumuqi
China	Research Site	Xian
China	Research Site	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate the safety of linaclotide therapy	The primary objective of current study is to demonstrate the safety of linaclotide therapy by assessment of the incidence of any adverse events (AEs) , serious adverse events (SAEs) , AEs by severity, ADRs and AEs leading to linaclotide-associated interruption, discontinuation, and death during 6-month follow up in Chinese patients.	2023/09/30
Secondary	Assess the treatment satisfaction	To observe patients' treatment satisfaction status after treatment via a 5-point treatment satisfaction scale (1=not at all, 2=a little, 3=somewhat, 4=very, 5=extremely)	2023/09/30
Secondary	Assess the impact of linaclotide treatment in patient's quality of life.	To describe patient's quality of life after treatment via the Irritable Bowel Syndrome-Quality of Life Measure (IBS-QoL).	2023/09/30