Evaluate the Safety of Linaclotide in IBS-C Patients in China (Liberty)

AstraZeneca

Status: Completed

Conditions: Irritable Bowel Syndrome-IBS

Study type: Observational

Funder types: Industry

Identifiers

NCT04462900

D5630R00001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,028 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 -