Status:
COMPLETED
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases)
Irritable Bowel Syndrome With Constipation (IBS-C)
Eligibility:
All Genders
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 tim...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
October 2 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
2475 Patients enrolled
Trial Details
Trial ID
NCT03471728
Start Date
October 2 2017
End Date
December 31 2021
Last Update
October 18 2024
Active Locations (47)
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1
Site JP00023
Aichi, Japan
2
Site JP00005
Akita, Japan
3
Site JP00002
Aomori, Japan
4
Site JP00012
Chiba, Japan