Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03471728 |
|
Recruitment Status :
Completed
First Posted : March 21, 2018
Last Update Posted : January 20, 2022
|
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.
| Condition or disease | Intervention/treatment |
|---|---|
| Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases) Irritable Bowel Syndrome With Constipation (IBS-C) | Drug: linaclotide |
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.
| Study Type : | Observational |
| Actual Enrollment : | 2475 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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) |
| Actual Study Start Date : | October 2, 2017 |
| Actual Primary Completion Date : | December 31, 2021 |
| Actual Study Completion Date : | December 31, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Constipation
| Group/Cohort | Intervention/treatment |
|---|---|
|
Irritable Bowel Syndrome
Patients with Irritable Bowel Syndrome with Constipation (IBS-C) who have used linaclotide for the first time
|
Drug: linaclotide
Oral
Other Names:
|
|
Chronic Constipation
Patients with Chronic Constipation (CC) (excluding constipation due to organic diseases) who have used linaclotide for the first time
|
Drug: linaclotide
Oral
Other Names:
|
Primary Outcome Measures :
- Incidence of diarrhea [ Time Frame: Up to Week 36 ]To assess the incidence of diarrhea as a criteria of safety variables.
Secondary Outcome Measures :
- 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).
- 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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471728
Locations
Show 47 study locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Central Contact | Astellas Pharma Inc |
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT03471728 |
| Other Study ID Numbers: |
0456-MA-3141 |
| First Posted: | March 21, 2018 Key Record Dates |
| Last Update Posted: | January 20, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas." |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Astellas Pharma Inc:
|
Linaclotide Linzess Irritable Bowel Syndrome Chronic Constipation |
Additional relevant MeSH terms:
|
Irritable Bowel Syndrome Syndrome Constipation Disease Pathologic Processes Signs and Symptoms, Digestive Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Linaclotide Guanylyl Cyclase C Agonists Enzyme Activators Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |