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

[PMS] LINZESS® Tablet 0.25mg Long-term Specified Drug Use-results Survey in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03471728

Enrollment

2475

Registered

2018-03-21

Start date

2017-10-02

Completion date

2021-12-31

Last updated

2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Linaclotide, Linzess, Irritable Bowel Syndrome, Chronic Constipation

Brief summary

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

Detailed 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.

Interventions

DRUGlinaclotide

Oral

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of diarrhea	Up to Week 36	To assess the incidence of diarrhea as a criteria of safety variables.

Secondary

Measure	Time frame	Description
Safety assessed by incidence of adverse drug reactions	Up to Week 36	Adverse drug reactions will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Efficacy assessed by Global assessment of relief of IBS and constipation symptoms	Up to Week 36	Global assessment of relief of IBS and constipation symptoms will be evaluated based on the clinical course in a medical interview with the patient and evaluate efficacy using a 7-point scale: 1: much better; 2: better; 3: a little better; 4: no change; 5: a little worse; 6: worse; 7: much worse. If the evaluation is impossible, a reason will be provided.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026