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

January 19, 2022 updated by: Astellas Pharma Inc

[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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2475

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan
        • Site JP00023
      • Akita, Japan
        • Site JP00005
      • Aomori, Japan
        • Site JP00002
      • Chiba, Japan
        • Site JP00012
      • Ehime, Japan
        • Site JP00038
      • Fukui, Japan
        • Site JP00018
      • Fukuoka, Japan
        • Site JP00040
      • Fukushima, Japan
        • Site JP00007
      • Gifu, Japan
        • Site JP00021
      • Gunma, Japan
        • Site JP00010
      • Hiroshima, Japan
        • Site JP00034
      • Hokkaido, Japan
        • Site JP00001
      • Hyogo, Japan
        • Site JP00028
      • Ibaraki, Japan
        • Site JP00008
      • Ishikawa, Japan
        • Site JP00017
      • Iwate, Japan
        • Site JP00003
      • Kagawa, Japan
        • Site JP00037
      • Kagoshima, Japan
        • Site JP00046
      • Kanagawa, Japan
        • Site JP00014
      • Kochi, Japan
        • Site JP00039
      • Kumamoto, Japan
        • Site JP00043
      • Kyoto, Japan
        • Site JP00026
      • Mie, Japan
        • Site JP00024
      • Miyagi, Japan
        • Site JP00004
      • Miyazaki, Japan
        • Site JP00045
      • Nagano, Japan
        • Site JP00020
      • Nagasaki, Japan
        • Site JP00042
      • Nara, Japan
        • Site JP00029
      • Niigata, Japan
        • Site JP00015
      • Oita, Japan
        • Site JP00044
      • Okayama, Japan
        • Site JP00033
      • Okinawa, Japan
        • Site JP00047
      • Osaka, Japan
        • Site JP00027
      • Saga, Japan
        • Site JP00041
      • Saitama, Japan
        • Site JP00011
      • Shiga, Japan
        • Site JP00025
      • Shimane, Japan
        • Site JP00032
      • Shizuoka, Japan
        • Site JP00022
      • Tochigi, Japan
        • Site JP00009
      • Tokushima, Japan
        • Site JP00036
      • Tokyo, Japan
        • Site JP00013
      • Tottori, Japan
        • Site JP00031
      • Toyama, Japan
        • Site JP00016
      • Wakayama, Japan
        • Site JP00030
      • Yamagata, Japan
        • Site JP00006
      • Yamaguchi, Japan
        • Site JP00035
      • Yamanashi, Japan
        • Site JP00019

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Irritable Bowel Syndrome
Patients with Irritable Bowel Syndrome with Constipation (IBS-C) who have used linaclotide for the first time
Drug: linaclotide
Oral
Other Names:
  • Linzess
  • ASP0456
Chronic Constipation
Patients with Chronic Constipation (CC) (excluding constipation due to organic diseases) who have used linaclotide for the first time
Drug: linaclotide
Oral
Other Names:
  • Linzess
  • ASP0456

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety assessed by incidence of adverse drug reactions
Time Frame: Up to Week 36
Adverse drug reactions will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Up to Week 36
Efficacy assessed by Global assessment of relief of IBS and constipation symptoms
Time Frame: 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.
Up to Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 2, 2017

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (ACTUAL)

March 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0456-MA-3141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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