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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3028 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-18

Study Completion Date

2023-02-03

Brief Summary

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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.

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Detailed Description

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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

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Irritable Bowel Syndrome-IBS

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No