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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04462900

Acronym

Liberty

Enrollment

3028

Registered

2020-07-08

Start date

2020-09-18

Completion date

2023-02-03

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome-IBS

Keywords

IBS

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 -

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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).

Countries

China

Outcome results