Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases)NCT03471728
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
An observational study of Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases) and Irritable Bowel Syndrome With Constipation (IBS-C), run by Astellas Pharma Inc at 47 sites in Japan.
Trial summary
The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases), Irritable Bowel Syndrome With Constipation (IBS-C)
- What is being tested?
- linaclotide
- Type of treatment
- Pill or oral medicine
- How many people
- 2,475 participants
- Where
- 47 sitesJapan
- Study dates
- 2 Oct 2017to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Japan47 sites
Site JP00023
Aichi
Site JP00005
Akita
Site JP00002
Aomori
Site JP00012
Chiba
Site JP00038
Ehime
Site JP00018
Fukui
Site JP00040
Fukuoka
Site JP00007
Fukushima
Site JP00021
Gifu
Site JP00010
Gunma
Site JP00034
Hiroshima
Site JP00001
Hokkaido
Site JP00028
Hyōgo
Site JP00008
Ibaraki
Site JP00017
Ishikawa
Site JP00037
Kagawa
Site JP00046
Kagoshima
Site JP00014
Kanagawa
Site JP00039
Kochi
Site JP00043
Kumamoto
Site JP00026
Kyoto
Site JP00024
Mie
Site JP00004
Miyagi
Site JP00045
Miyazaki
Site JP00020
Nagano
Site JP00042
Nagasaki
Site JP00029
Nara
Site JP00015
Niigata
Site JP00003
Numakunai
Site JP00044
Ōita
Site JP00033
Okayama
Site JP00047
Okinawa
Site JP00027
Osaka
Site JP00041
Saga
Site JP00011
Saitama
Site JP00025
Shiga
Site JP00032
Shimane
Site JP00022
Shizuoka
Site JP00009
Tochigi
Site JP00036
Tokushima
Site JP00013
Tokyo
Site JP00031
Tottori
Site JP00016
Toyama
Site JP00030
Wakayama
Site JP00006
Yamagata
Site JP00035
Yamaguchi
Site JP00019
Yamanashi
About this study
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)
The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.
Read the 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)
- Being tested
- linaclotide
- Keywords
- Linaclotide, Linzess, Irritable Bowel Syndrome, Chronic Constipation
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linaclotideDrug
Also called Linzess, ASP0456
Oral
| Study group | Role | What they receive |
|---|---|---|
| Irritable Bowel Syndrome | Patients with Irritable Bowel Syndrome with Constipation (IBS-C) who have used linaclotide for the first time Receives: Drug: linaclotide | |
| Chronic Constipation | Patients with Chronic Constipation (CC) (excluding constipation due to organic diseases) who have used linaclotide for the first time Receives: Drug: linaclotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of diarrhea
To assess the incidence of diarrhea as a criteria of safety variables.
Measured: Up to Week 36
Secondary outcomes (2)
Safety assessed by incidence of adverse drug reactions
Adverse drug reactions will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Measured: 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.
Measured: Up to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start2 Oct 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471728
- Sponsor's protocol ID
- 0456-MA-3141
- Status last verified
- Oct 2024
- First submitted
- 14 Mar 2018
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03471728
- Acronym / sponsor ID
- 0456-MA-3141
- Conditions
- Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases), Irritable Bowel Syndrome With Constipation (IBS-C)
- Keywords
- Linaclotide, Linzess, Irritable Bowel Syndrome, Chronic Constipation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,475 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irritable Bowel Syndrome | – | Drug: linaclotidePatients with Irritable Bowel Syndrome with Constipation (IBS-C) who have used linaclotide for the first time |
| Chronic Constipation | – | Drug: linaclotidePatients with Chronic Constipation (CC) (excluding constipation due to organic diseases) who have used linaclotide for the first time |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| linaclotideAlso: Linzess, ASP0456Oral | Drug | Chronic Constipation, Irritable Bowel Syndrome |
Primary outcome
Incidence of diarrhea
Time frame: Up to Week 36
To assess the incidence of diarrhea as a criteria of safety variables.
2 secondary outcomes
Safety assessed by incidence of adverse drug reactions
Time frame: Up to Week 36
Efficacy assessed by Global assessment of relief of IBS and constipation symptoms
Time frame: Up to Week 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Central Contact study director
Astellas Pharma Inc
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases) and Irritable Bowel Syndrome With Constipation (IBS-C), run by Astellas Pharma Inc at 47 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of diarrhea (time frame: Up to Week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.