clinical trial · NCT03471728
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases)Irritable Bowel Syndrome With Constipation (IBS-C)linaclotide
brief summary
The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.
started
Oct 2, 2017
primary completion
Dec 31, 2021
completion
Dec 31, 2021
last updated
Oct 18, 2024
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.
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol