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

May 10, 2024 updated by: AstraZeneca

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

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)

3028

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2023/09/30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2023/09/30
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).
2023/09/30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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