Clinical trial NCT04462900: Evaluate the Safety of Linaclotide in IBS-C Patients in China
Official title: Multi-center, Single Arm, Observational Study to Evaluate the Safety of Linaclotide in IBS-C Patients in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome-IBS
Keywords: IBS
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 3028
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Demonstrate the safety of linaclotide therapy
timeFrame: 2023/09/30
Secondary outcomes:
measure: Assess the treatment satisfaction
timeFrame: 2023/09/30
measure: Assess the impact of linaclotide treatment in patient's quality of life.
timeFrame: 2023/09/30
Other outcomes:
Locations:
city: Baotou
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Binzhou
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Leshan
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Suzhou
country: China
facility: Research Site
city: Taiyuan
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Wenzhou
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wulumuqi
country: China
facility: Research Site
city: Xian
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
Study officials:
References: