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

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

Detailed Description
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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
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[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)

Conditions
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Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases), Irritable Bowel Syndrome With Constipation (IBS-C)

Intervention / Treatment
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* Drug: linaclotide


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Irritable Bowel Syndrome<br>Patients with Irritable Bowel Syndrome with Constipation (IBS-C) who have used linaclotide for the first time | Drug: linaclotide<br>* Oral<br>* Other names: ASP0456;|
| Chronic Constipation<br>Patients with Chronic Constipation (CC) (excluding constipation due to organic diseases) who have used linaclotide for the first time | Drug: linaclotide<br>* Oral<br>* Other names: ASP0456;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of diarrhea | To assess the incidence of diarrhea as a criteria of safety variables. | Up to Week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Linaclotide, Linzess, Irritable Bowel Syndrome, Chronic Constipation