NCT04462900

Evaluate the Safety of Linaclotide in IBS-C Patients in China

Multi-center, Single Arm, Observational Study to Evaluate the Safety of Linaclotide in IBS-C Patients in China

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,028 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome-IBS

Timeline

• Start date: 2020-09-18
• Primary completion: 2023-02-03
• Completion: 2023-02-03
• First posted: 2020-07-08
• Last updated: 2024-05-13

Locations

29 sites across 1 country: China