DRUG
linaclotide
Oral
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
Status
Completed
Phase
Not applicable
Enrollment
2,475
Locations
47
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 21, 2018
Study start
Oct 2, 2017
Primary completion
Dec 31, 2021
Study completion
Dec 31, 2021
Results posted
Not reported
Registry updated
Oct 18, 2024
Outcomes
What the study measures.
Primary outcomes
Incidence of diarrhea
Time frame · Up to Week 36
To assess the incidence of diarrhea as a criteria of safety variables.
Secondary outcomes
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.
Eligibility
Who can take part.
- Minimum age
- Not reported
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
47 registered sites.
Japan. Showing up to 24 locations stored in the fast local snapshot.
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
Hyōgo, Japan
Site JP00008
Ibaraki, Japan
Site JP00017
Ishikawa, 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
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Linaclotide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Study of Virtual Reality and Linaclotide for IBS-C
Mayo Clinic · Irritable Bowel Syndrome With Constipation
Not applicable
Recruiting
65
2026-07
Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Colorectal Adenoma · Stage 0 Colorectal Cancer AJCC v8
Phase 2
Active, not recruiting
150
2026-07
A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
AbbVie · Functional Constipation (FC) · Chronic Idiopathic Constipation (CIC)
Phase 3
Completed
123
2026-05
Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis
University of Nottingham · Cystic Fibrosis (CF)
Early Phase 1
Recruiting
26
2026-05
GCC Agonist Signal in the Small Intestine
University of Wisconsin, Madison · Barrett Esophagus · Gastroesophageal Reflux Disease
Phase 1
Completed
43
2026-04
Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation
Texas Tech University Health Sciences Center, El Paso · Chronic Constipation · Diabete Mellitus
Phase 4
Active, not recruiting
23
2026-04
"Efficacy and Safety of Linaclotide in Chronic Constipation"
Md Mehedi Shahriar · Chronic Idiopathic Constipation · Irritable Bowel Syndrome (IBS-C)
Phase 4
Not yet recruiting
90
2026-02
Linaclotide for Colonoscopy Bowel Prep
University of Florida · Patients Scheduled for Colonoscopy
Phase 1 / Phase 2
Recruiting
10
2026-01
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.