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

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.

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Key information

Conditions

Irritable Bowel Syndrome-IBS Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Baotou, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Primary outcomes

Demonstrate the safety of linaclotide therapy

Time frame: 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 outcomes

Assess the treatment satisfaction

Time frame: 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)
Assess the impact of linaclotide treatment in patient's quality of life.

Time frame: 2023/09/30

To describe patient's quality of life after treatment via the Irritable Bowel Syndrome-Quality of Life Measure (IBS-QoL).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: Liberty

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Jul 8, 2020
Registry last updated: May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed