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

Completed

• Conditions: Irritable Bowel Syndrome With Constipation (IBS-C); Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases)
• Interventions: Drug: linaclotide

• Registration Number: NCT03471728
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study Start: 2017-10-02
• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-14
• Study First Posted: 2018-03-21
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2475

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of diarrhea	Up to Week 36	To assess the incidence of diarrhea as a criteria of safety variables.

Secondary Outcome Measures

Name	Time	Method
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.
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).

Trial Locations

Locations (47)

Site JP00023; 🇯🇵 Aichi, Japan

Site JP00005; 🇯🇵 Akita, Japan

Site JP00002; 🇯🇵 Aomori, Japan

Site JP00012; 🇯🇵 Chiba, Japan

Site JP00038; 🇯🇵 Ehime, Japan

Site JP00018; 🇯🇵 Fukui, Japan

Site JP00040; 🇯🇵 Fukuoka, Japan

Site JP00007; 🇯🇵 Fukushima, Japan

Site JP00021; 🇯🇵 Gifu, Japan

Site JP00010; 🇯🇵 Gunma, Japan

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