Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
- Conditions
- Irritable Bowel Syndrome With Constipation (IBS-C)Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases)
- Interventions
- Registration Number
- NCT03471728
- Lead Sponsor
- Astellas Pharma Inc
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2475
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic Constipation linaclotide Patients with Chronic Constipation (CC) (excluding constipation due to organic diseases) who have used linaclotide for the first time Irritable Bowel Syndrome linaclotide Patients with Irritable Bowel Syndrome with Constipation (IBS-C) who have used linaclotide for the first time
- Primary Outcome Measures
Name Time Method Incidence of diarrhea Up to Week 36 To assess the incidence of diarrhea as a criteria of safety variables.
- Secondary Outcome Measures
Name Time Method Efficacy assessed by Global assessment of relief of IBS and constipation symptoms 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.
Safety assessed by incidence of adverse drug reactions Up to Week 36 Adverse drug reactions will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Trial Locations
- Locations (47)
Site JP00003
🇯🇵Iwate, Japan
Site JP00039
🇯🇵Kochi, Japan
Site JP00028
🇯🇵Hyogo, Japan
Site JP00021
🇯🇵Gifu, Japan
Site JP00019
🇯🇵Yamanashi, Japan
Site JP00029
🇯🇵Nara, Japan
Site JP00033
🇯🇵Okayama, Japan
Site JP00047
🇯🇵Okinawa, Japan
Site JP00032
🇯🇵Shimane, Japan
Site JP00038
🇯🇵Ehime, Japan
Site JP00023
🇯🇵Aichi, Japan
Site JP00012
🇯🇵Chiba, Japan
Site JP00007
🇯🇵Fukushima, Japan
Site JP00005
🇯🇵Akita, Japan
Site JP00014
🇯🇵Kanagawa, Japan
Site JP00010
🇯🇵Gunma, Japan
Site JP00008
🇯🇵Ibaraki, Japan
Site JP00043
🇯🇵Kumamoto, Japan
Site JP00031
🇯🇵Tottori, Japan
Site JP00004
🇯🇵Miyagi, Japan
Site JP00045
🇯🇵Miyazaki, Japan
Site JP00020
🇯🇵Nagano, Japan
Site JP00027
🇯🇵Osaka, Japan
Site JP00011
🇯🇵Saitama, Japan
Site JP00025
🇯🇵Shiga, Japan
Site JP00013
🇯🇵Tokyo, Japan
Site JP00037
🇯🇵Kagawa, Japan
Site JP00046
🇯🇵Kagoshima, Japan
Site JP00015
🇯🇵Niigata, Japan
Site JP00044
🇯🇵Oita, Japan
Site JP00035
🇯🇵Yamaguchi, Japan
Site JP00041
🇯🇵Saga, Japan
Site JP00009
🇯🇵Tochigi, Japan
Site JP00036
🇯🇵Tokushima, Japan
Site JP00016
🇯🇵Toyama, Japan
Site JP00030
🇯🇵Wakayama, Japan
Site JP00006
🇯🇵Yamagata, Japan
Site JP00002
🇯🇵Aomori, Japan
Site JP00040
🇯🇵Fukuoka, Japan
Site JP00034
🇯🇵Hiroshima, Japan
Site JP00018
🇯🇵Fukui, Japan
Site JP00001
🇯🇵Hokkaido, Japan
Site JP00017
🇯🇵Ishikawa, Japan
Site JP00024
🇯🇵Mie, Japan
Site JP00026
🇯🇵Kyoto, Japan
Site JP00022
🇯🇵Shizuoka, Japan
Site JP00042
🇯🇵Nagasaki, Japan