Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)

Astellas

Status: Completed

Conditions: Irritable Bowel Syndrome With Constipation (IBS-C); Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases)

Treatments: Drug: linaclotide

Study type: Observational

Funder types: Industry

Identifiers

NCT03471728

0456-MA-3141

Details and patient eligibility

About

The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.

Full description

This is a post-marketing long-term specified drug use-result survey study required for products in Japan. The investigator will register the patient who have been taking this product for the first time within 14 days after the start of treatment (inclusive of the start day). For each of the registered patients (including withdrawals and dropouts), the investigator will enter the survey data on the case report form.

Enrollment: 2,475 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients with Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Constipation (CC) (excluding constipation due to organic diseases) who have used linaclotide for the first time

Trial design

2,475 participants in 2 patient groups

Irritable Bowel Syndrome

Description:

Patients with Irritable Bowel Syndrome with Constipation (IBS-C) who have used linaclotide for the first time

Treatment:

Drug: linaclotide

Chronic Constipation

Description:

Patients with Chronic Constipation (CC) (excluding constipation due to organic diseases) who have used linaclotide for the first time

Treatment:

Drug: linaclotide