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Completed

NCT Number: NCT03471728

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

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

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Key information

Conditions

Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases) Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Irritable Bowel Syndrome With Constipation (IBS-C)

Sex eligibility

All sexes

Study type

Observational

Primary location

Site JP00023, Aichi, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linaclotide

Drug

Oral

Other names: Linzess, ASP0456

Primary outcomes

  1. Incidence of diarrhea

    Time frame: Up to Week 36

    To assess the incidence of diarrhea as a criteria of safety variables.

Secondary outcomes

  1. Safety assessed by incidence of adverse drug reactions

    Time frame: Up to Week 36

    Adverse drug reactions will be coded using Medical Dictionary for Regulatory Activities (MedDRA).

  2. Efficacy assessed by Global assessment of relief of IBS and constipation symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 21, 2018
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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