The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.
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
Enrollment
2,475
Oral
Incidence of diarrhea
To assess the incidence of diarrhea as a criteria of safety variables.
Time frame: Up to Week 36
Safety assessed by incidence of adverse drug reactions
Adverse drug reactions will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Time frame: 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.
Time frame: Up to Week 36
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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
...and 37 more locations