Status:
COMPLETED
Evaluate the Safety of Linaclotide in IBS-C Patients in China
Lead Sponsor:
AstraZeneca
Conditions:
Irritable Bowel Syndrome-IBS
Eligibility:
All Genders
18+ years
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 aroun...
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. Pat...
Eligibility Criteria
Inclusion
- ≧ 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
- 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 -
Key Trial Info
Start Date :
September 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 3 2023
Estimated Enrollment :
3028 Patients enrolled
Trial Details
Trial ID
NCT04462900
Start Date
September 18 2020
End Date
February 3 2023
Last Update
May 13 2024
Active Locations (29)
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1
Research Site
Baotou, China, 14030
2
Research Site
Beijing, China, 100730
3
Research Site
Beijing, China
4
Research Site
Binzhou, China, 256603