Status
Completed
Phase
Not applicable
Enrollment
3,028
Locations
29
Results
Not posted
Publications
0
Study 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.
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
No intervention details reported.
Timeline
First posted
Jul 8, 2020
Study start
Sep 18, 2020
Primary completion
Feb 3, 2023
Study completion
Feb 3, 2023
Results posted
Not reported
Registry updated
May 13, 2024
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.
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).
Eligibility
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 locations
China. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Baotou, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Binzhou, China
Research Site
Chengdu, China
Research Site
Chongqing, China
Research Site
Guangzhou, China
Research Site
Guangzhou, China
Research Site
Guangzhou, China
Research Site
Jinan, China
Research Site
Leshan, China
Research Site
Nanchang, China
Research Site
Nanjing, China
Research Site
Nanjing, China
Research Site
Qingdao, China
Research Site
Shanghai, China
Research Site
Shanghai, China
Research Site
Shanghai, China
Research Site
Shenyang, China
Research Site
Shenzhen, China
Research Site
Shenzhen, China
Research Site
Suzhou, China
Research Site
Taiyuan, China
Research Site
Tianjin, China
Publications
No PMID-linked publications were present in this registry snapshot.
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