Post-marketing Surveillance of Linaclotide Tablet in Pati... | NCT03471728

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

NCT03471728

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Oct 18, 2024Actual

Enrollment

2,475Actual

Phase

Not provided

Conditions

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

Interventions

linaclotide

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2, 2017Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Mar 14, 2018

First Submission Date that Met QC Criteria

Mar 14, 2018

First Posted Date

Mar 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2024

Last Update Posted Date

Oct 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,475Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Irritable Bowel Syndrome		Patients with Irritable Bowel Syndrome with Constipation (IBS-C) who have used linaclotide for the first time	Drug: linaclotide
Chronic Constipation		Patients with Chronic Constipation (CC) (excluding constipation due to organic diseases) who have used linaclotide for the first time	Drug: linaclotide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
linaclotide	Drug	Oral	Chronic Constipation Irritable Bowel Syndrome

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Safety assessed by incidence of adverse drug reactions	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Central Contact	Astellas Pharma Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site JP00023		Aichi			Japan
Site JP00005

IPD Sharing Statement Module

Plan to Share IPD

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/.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases