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

Completed

• Conditions: Irritable Bowel Syndrome-IBS

• Registration Number: NCT04462900
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-07-03
• Study First Posted: 2020-07-08
• Study Start: 2020-09-18
• Primary Completion: 2023-02-03
• Study Completion: 2023-02-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3028

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demonstrate the safety of linaclotide therapy	2023/09/30	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.

Secondary Outcome Measures

Name	Time	Method
Assess the impact of linaclotide treatment in patient's quality of life.	2023/09/30	To describe patient's quality of life after treatment via the Irritable Bowel Syndrome-Quality of Life Measure (IBS-QoL).
Assess the treatment satisfaction	2023/09/30	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)

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhengzhou, China