Irritable Bowel Syndrome With Constipation (IBS-C) Clinical Trial
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)
Verified date | January 2022 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.
Status | Completed |
Enrollment | 2475 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Japan | Site JP00023 | Aichi | |
Japan | Site JP00005 | Akita | |
Japan | Site JP00002 | Aomori | |
Japan | Site JP00012 | Chiba | |
Japan | Site JP00038 | Ehime | |
Japan | Site JP00018 | Fukui | |
Japan | Site JP00040 | Fukuoka | |
Japan | Site JP00007 | Fukushima | |
Japan | Site JP00021 | Gifu | |
Japan | Site JP00010 | Gunma | |
Japan | Site JP00034 | Hiroshima | |
Japan | Site JP00001 | Hokkaido | |
Japan | Site JP00028 | Hyogo | |
Japan | Site JP00008 | Ibaraki | |
Japan | Site JP00017 | Ishikawa | |
Japan | Site JP00003 | Iwate | |
Japan | Site JP00037 | Kagawa | |
Japan | Site JP00046 | Kagoshima | |
Japan | Site JP00014 | Kanagawa | |
Japan | Site JP00039 | Kochi | |
Japan | Site JP00043 | Kumamoto | |
Japan | Site JP00026 | Kyoto | |
Japan | Site JP00024 | Mie | |
Japan | Site JP00004 | Miyagi | |
Japan | Site JP00045 | Miyazaki | |
Japan | Site JP00020 | Nagano | |
Japan | Site JP00042 | Nagasaki | |
Japan | Site JP00029 | Nara | |
Japan | Site JP00015 | Niigata | |
Japan | Site JP00044 | Oita | |
Japan | Site JP00033 | Okayama | |
Japan | Site JP00047 | Okinawa | |
Japan | Site JP00027 | Osaka | |
Japan | Site JP00041 | Saga | |
Japan | Site JP00011 | Saitama | |
Japan | Site JP00025 | Shiga | |
Japan | Site JP00032 | Shimane | |
Japan | Site JP00022 | Shizuoka | |
Japan | Site JP00009 | Tochigi | |
Japan | Site JP00036 | Tokushima | |
Japan | Site JP00013 | Tokyo | |
Japan | Site JP00031 | Tottori | |
Japan | Site JP00016 | Toyama | |
Japan | Site JP00030 | Wakayama | |
Japan | Site JP00006 | Yamagata | |
Japan | Site JP00035 | Yamaguchi | |
Japan | Site JP00019 | Yamanashi |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of diarrhea | To assess the incidence of diarrhea as a criteria of safety variables. | Up to Week 36 | |
Secondary | 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 | |
Secondary | 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 |
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