Trials / Completed
CompletedNCT03471728
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
[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)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,475 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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 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.
Conditions
- Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases)
- Irritable Bowel Syndrome With Constipation (IBS-C)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | linaclotide | Oral |
Timeline
- Start date
- 2017-10-02
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
- First posted
- 2018-03-21
- Last updated
- 2024-10-18
Locations
47 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03471728. Inclusion in this directory is not an endorsement.