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

October 17, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Central Contact, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

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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