Irritable Bowel Syndrome-IBSLibertyNCT04462900
Evaluate the Safety of Linaclotide in IBS-C Patients in China
An observational study of Irritable Bowel Syndrome-IBS, run by AstraZeneca at 29 sites in China.
Trial summary
This is a Multi-center, single arm, observational study to evaluate the safety of linaclotide in IBS-C patients in China. Enrolls approximately 3,000 Chinese patients from 30 participating sites around China and followed up for half year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome-IBS
- How many people
- 3,028 participants
- Where
- 29 sitesChina
- Study dates
- 18 Sep 2020to 3 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 3,000 Chinese patients in China, Patients will be eligible for the study after taking at least one dose of linaclotide. Duration will from 2020 Q2 to 2023 Q1.
Who may be able to join
- ≧ 18 years old
- Provision of subject informed consent prior to any study procedures
- Has taken at least one dose of linaclotide
- NOT participating in any interventional study currently or during the last 3 months
Who cannot join
- If linaclotide is contraindicated according to the product prescribing information
- Being unable to comply with study-specified procedure
- Has ever participated in current study before -
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites
Research Site
Baotou, 14030
Research Site
Beijing, 100730
Research Site
Beijing
Research Site
Binzhou, 256603
Research Site
Chengdu, 610014
Research Site
Chongqing
Research Site
Guangzhou, 510000
Research Site
Guangzhou, 510655
Research Site
Guangzhou, 518110
Research Site
Jinan, 250012
Research Site
Leshan, 614000
Research Site
Nanchang, 330006
Research Site
Nanjing, 210008
Research Site
Nanjing, 210029
Research Site
Qingdao
Research Site
Shanghai, 200025
Research Site
Shanghai, 200433
Research Site
Shanghai
Research Site
Shenyang, 110001
Research Site
Shenzhen, 518035
Research Site
Shenzhen
Research Site
Suzhou
Research Site
Taiyuan, 030012
Research Site
Tianjin, 300052
Research Site
Ürümqi
Research Site
Wenzhou
Research Site
Wuhan, 430022
Research Site
Xi'an, 710000
Research Site
Zhengzhou, 450003
About this study
Official title: Multi-center, Single Arm, Observational Study to Evaluate the Safety of Linaclotide in IBS-C Patients in China
This is a Multi-center, single arm, observational study to evaluate the safety of linaclotide in IBS-C patients in China. Enrolls approximately 3,000 Chinese patients from 30 participating sites around China and followed up for half year.
Read the detailed description
This is a multi-center, one arm, prospective observational study which enrolls approximately 3,000 Chinese patients in China.The study will be performed under real world clinical practice setting. Patients will be eligible for the study after taking at least one dose of linaclotide. Every patient will be followed maximum of 6 months after enrollment. Study measures will be collected at baseline and during the follow-up period. Incidence of adverse events will be employed to assess the safety and tolerability of linaclotide in Chinese patients. The treatment satisfaction will be employed to assess the impact of treatment. The Irritable Bowel Syndrome-Quality of Life Measure (IBS-QoL) will be employed to assess the patient's quality of life.
- Conditions
- Irritable Bowel Syndrome-IBS
- Keywords
- IBS
- Medical subject headings
- Irritable Bowel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the safety of linaclotide therapy
The primary objective of current study is to demonstrate the safety of linaclotide therapy by assessment of the incidence of any adverse events (AEs) , serious adverse events (SAEs) , AEs by severity, ADRs and AEs leading to linaclotide-associated interruption, discontinuation, and death during 6-month follow up in Chinese patients.
Measured: 2023/09/30
Secondary outcomes (2)
Assess the treatment satisfaction
To observe patients' treatment satisfaction status after treatment via a 5-point treatment satisfaction scale (1=not at all, 2=a little, 3=somewhat, 4=very, 5=extremely)
Measured: 2023/09/30
Assess the impact of linaclotide treatment in patient's quality of life.
To describe patient's quality of life after treatment via the Irritable Bowel Syndrome-Quality of Life Measure (IBS-QoL).
Measured: 2023/09/30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start18 Sep 2020
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome-IBSStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 3,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462900
- Sponsor's protocol ID
- D5630R00001
- Acronym
- Liberty
- Status last verified
- Mar 2024
- First submitted
- 19 Jun 2020
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Single Arm, Observational Study to Evaluate the Safety of Linaclotide in IBS-C Patients in China
- ClinicalTrials.gov ID
- NCT04462900
- Acronym / sponsor ID
- Liberty / D5630R00001
- Conditions
- Irritable Bowel Syndrome-IBS
- Keywords
- IBS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,028 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 8 Jul 2020 (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.
This is a Multi-center, single arm, observational study to evaluate the safety of linaclotide in IBS-C patients in China. Enrolls approximately 3,000 Chinese patients from 30 participating sites around China and followed up for half year.
Detailed description
This is a multi-center, one arm, prospective observational study which enrolls approximately 3,000 Chinese patients in China.The study will be performed under real world clinical practice setting. Patients will be eligible for the study after taking at least one dose of linaclotide. Every patient will be followed maximum of 6 months after enrollment. Study measures will be collected at baseline and during the follow-up period. Incidence of adverse events will be employed to assess the safety and tolerability of linaclotide in Chinese patients. The treatment satisfaction will be employed to assess the impact of treatment. The Irritable Bowel Syndrome-Quality of Life Measure (IBS-QoL) will be employed to assess the patient's quality of life.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 3,000 Chinese patients in China, Patients will be eligible for the study after taking at least one dose of linaclotide. Duration will from 2020 Q2 to 2023 Q1.
Key inclusion criteria (4 listed)
- ≧ 18 years old
- Provision of subject informed consent prior to any study procedures
- Has taken at least one dose of linaclotide
- NOT participating in any interventional study currently or during the last 3 months
Key exclusion criteria (3 listed)
- If linaclotide is contraindicated according to the product prescribing information
- Being unable to comply with study-specified procedure
- Has ever participated in current study before -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demonstrate the safety of linaclotide therapy
Time frame: 2023/09/30
The primary objective of current study is to demonstrate the safety of linaclotide therapy by assessment of the incidence of any adverse events (AEs) , serious adverse events (SAEs) , AEs by severity, ADRs and AEs leading to linaclotide-associated interruption, discontinuation, and death during 6-month follow up in Chinese patients.
2 secondary outcomes
Assess the treatment satisfaction
Time frame: 2023/09/30
Assess the impact of linaclotide treatment in patient's quality of life.
Time frame: 2023/09/30
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 13 May 2024.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome-IBS, run by AstraZeneca at 29 sites in China.
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 4 inclusion and 3 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 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. 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?
Demonstrate the safety of linaclotide therapy (time frame: 2023/09/30). 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 13 May 2024.