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

NCT ID: NCT03471728

Last Updated: 2024-10-18

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

2475 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-02

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Irritable Bowel Syndrome

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

linaclotide

Intervention Type DRUG

Oral

Chronic Constipation

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

linaclotide

Intervention Type DRUG

Oral

Interventions

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linaclotide

Oral

Intervention Type DRUG

Other Intervention Names

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Linzess ASP0456

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Site JP00023

Aichi, , Japan

Site Status

Site JP00005

Akita, , Japan

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Site JP00002

Aomori, , Japan

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Site JP00012

Chiba, , Japan

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Site JP00038

Ehime, , Japan

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Site JP00018

Fukui, , Japan

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Site JP00040

Fukuoka, , Japan

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Site JP00007

Fukushima, , Japan

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Site JP00021

Gifu, , Japan

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Site JP00010

Gunma, , Japan

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Site JP00034

Hiroshima, , Japan

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Site JP00001

Hokkaido, , Japan

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Site JP00028

Hyōgo, , Japan

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Site JP00008

Ibaraki, , Japan

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Site JP00017

Ishikawa, , Japan

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Site JP00037

Kagawa, , Japan

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Site JP00046

Kagoshima, , Japan

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Site JP00014

Kanagawa, , Japan

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Site JP00039

Kochi, , Japan

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Site JP00043

Kumamoto, , Japan

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Site JP00026

Kyoto, , Japan

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Site JP00024

Mie, , Japan

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Site JP00004

Miyagi, , Japan

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Site JP00045

Miyazaki, , Japan

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Site JP00020

Nagano, , Japan

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Site JP00042

Nagasaki, , Japan

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Site JP00029

Nara, , Japan

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Site JP00015

Niigata, , Japan

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Site JP00003

Numakunai, , Japan

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Site JP00033

Okayama, , Japan

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Site JP00047

Okinawa, , Japan

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Site JP00027

Osaka, , Japan

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Site JP00044

Ōita, , Japan

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Site JP00041

Saga, , Japan

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Site JP00011

Saitama, , Japan

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Site JP00025

Shiga, , Japan

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Site JP00032

Shimane, , Japan

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Site JP00022

Shizuoka, , Japan

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Site JP00009

Tochigi, , Japan

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Site JP00036

Tokushima, , Japan

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Site JP00013

Tokyo, , Japan

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Site JP00031

Tottori, , Japan

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Site JP00016

Toyama, , Japan

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Site JP00030

Wakayama, , Japan

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Site JP00006

Yamagata, , Japan

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Site JP00035

Yamaguchi, , Japan

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Site JP00019

Yamanashi, , Japan

Site Status

Countries

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Japan

Other Identifiers

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0456-MA-3141

Identifier Type: -

Identifier Source: org_study_id

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