Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
[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)
1 other identifier
observational
2,475
1 country
47
Brief Summary
The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Longer than P75 for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 2, 2017
CompletedFirst Submitted
Initial submission to the registry
March 14, 2018
CompletedFirst Posted
Study publicly available on registry
March 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedOctober 18, 2024
October 1, 2024
4.2 years
March 14, 2018
October 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of diarrhea
To assess the incidence of diarrhea as a criteria of safety variables.
Up to Week 36
Secondary Outcomes (2)
Safety assessed by incidence of adverse drug reactions
Up to Week 36
Efficacy assessed by Global assessment of relief of IBS and constipation symptoms
Up to Week 36
Study Arms (2)
Irritable Bowel Syndrome
Patients with Irritable Bowel Syndrome with Constipation (IBS-C) who have used linaclotide for the first time
Chronic Constipation
Patients with Chronic Constipation (CC) (excluding constipation due to organic diseases) who have used linaclotide for the first time
Interventions
Eligibility 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
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Site JP00034
Hiroshima, Japan
Site JP00001
Hokkaido, Japan
Site JP00028
Hyōgo, Japan
Site JP00008
Ibaraki, Japan
Site JP00017
Ishikawa, 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 JP00003
Numakunai, Japan
Site JP00033
Okayama, Japan
Site JP00047
Okinawa, Japan
Site JP00027
Osaka, Japan
Site JP00044
Ōita, 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, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2018
First Posted
March 21, 2018
Study Start
October 2, 2017
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
October 18, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
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/.