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

Multi-center, Single Arm, Observational Study to 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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome-IBS

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 Type: Observational
• Enrollment (Actual): 3017

Contacts and Locations

Study Locations

• China
  • Baotou, China, 14030
    • Research Site
  • Beijing, China
    • Research Site
  • Beijing, China, 100730
    • Research Site
  • Binzhou, China, 256603
    • Research Site
  • Chengdu, China, 610014
    • Research Site
  • Chongqing, China
    • Research Site
  • Guangzhou, China, 510000
    • Research Site
  • Guangzhou, China, 510655
    • Research Site
  • Guangzhou, China, 518110
    • Research Site
  • Jinan, China, 250012
    • Research Site
  • Leshan, China, 614000
    • Research Site
  • Nanchang, China, 330006
    • Research Site
  • Nanjing, China, 210029
    • Research Site
  • Nanjing, China, 210008
    • Research Site
  • Qingdao, China
    • Research Site
  • Shanghai, China, 200433
    • Research Site
  • Shanghai, China
    • Research Site
  • Shanghai, China, 200025
    • Research Site
  • Shenyang, China, 110001
    • Research Site
  • Shenzhen, China
    • Research Site
  • Shenzhen, China, 518035
    • Research Site
  • Suzhou, China
    • Research Site
  • Taiyuan, China, 030012
    • Research Site
  • Tianjin, China, 300052
    • Research Site
  • Wenzhou, China
    • Research Site
  • Wuhan, China, 430022
    • Research Site
  • Wulumuqi, China
    • Research Site
  • Xian, China, 710000
    • Research Site
  • Zhengzhou, China, 450003
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Approximately 3,000 Chinese patients in China, Patients will be eligible for the study after taking at least one dose of linaclotide. Duration will from 2020 Q2 to 2023 Q1.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2020
• Primary Completion (ACTUAL): February 3, 2023
• Study Completion (ACTUAL): February 3, 2023

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (ACTUAL): July 8, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: IBS
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: D5630R00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No