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NCT03471728 Clinical Trial

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

Irritable Bowel Syndrome With Constipation (IBS-C) Clinical Trial

Official title:
[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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03471728
Other study ID # 0456-MA-3141
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2, 2017
Est. completion date December 31, 2021

Study information
Verified date January 2022
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 2475
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• linaclotide
Oral

Locations
Country Name City State
Japan 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 Site JP00034 Hiroshima
Japan Site JP00001 Hokkaido
Japan Site JP00028 Hyogo
Japan Site JP00008 Ibaraki
Japan Site JP00017 Ishikawa
Japan Site JP00003 Iwate
Japan Site JP00037 Kagawa
Japan Site JP00046 Kagoshima
Japan Site JP00014 Kanagawa
Japan Site JP00039 Kochi
Japan Site JP00043 Kumamoto
Japan Site JP00026 Kyoto
Japan Site JP00024 Mie
Japan Site JP00004 Miyagi
Japan Site JP00045 Miyazaki
Japan Site JP00020 Nagano
Japan Site JP00042 Nagasaki
Japan Site JP00029 Nara
Japan Site JP00015 Niigata
Japan Site JP00044 Oita
Japan Site JP00033 Okayama
Japan Site JP00047 Okinawa
Japan Site JP00027 Osaka
Japan Site JP00041 Saga
Japan Site JP00011 Saitama
Japan Site JP00025 Shiga
Japan Site JP00032 Shimane
Japan Site JP00022 Shizuoka
Japan Site JP00009 Tochigi
Japan Site JP00036 Tokushima
Japan Site JP00013 Tokyo
Japan Site JP00031 Tottori
Japan Site JP00016 Toyama
Japan Site JP00030 Wakayama
Japan Site JP00006 Yamagata
Japan Site JP00035 Yamaguchi
Japan Site JP00019 Yamanashi

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of diarrhea To assess the incidence of diarrhea as a criteria of safety variables. Up to Week 36
Secondary 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
Secondary Efficacy assessed by Global assessment of relief of IBS and constipation symptoms 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
See also
  Status Clinical Trial Phase
Completed NCT02316899 - Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome Phase 3
Completed NCT02493036 - A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-C Phase 2
Recruiting NCT05643534 - Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years Phase 3
Recruiting NCT05240521 - Efficacy and Safety, Tolerability of GA-AT0119 in IBS-C N/A
Completed NCT02495623 - A Study of the Effect of SYN-010 on Subjects With IBS-C Phase 2
Completed NCT01880424 - A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C) Phase 3
Completed NCT02078323 - Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients N/A
Enrolling by invitation NCT05905926 - Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C Phase 3