ConstipationNCT04861233
A Study of Lubiprostone to Treat Constipation
An observational study of Constipation, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
The main aim of this study is to check the side effects from lubiprostone in adults with constipation. Participants will be treated with lubiprostone according to their clinic's standard practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2021to 30 Nov 2024
- 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: Eligible participants with first incident prescription for treatment with lubiprostone will be enrolled.
Who may be able to join
- South Korean adult.
- With constipation caused by:
- Chronic Idiopathic Constipation (CIC), or
- Opioid-Induced Constipation (OIC) from treatment for chronic, non-cancer pain, including participants with chronic pain related to prior cancer or its treatment who do not require frequent (example weekly) opioid dosage escalation.
- Is newly prescribed (first incident) and initiates lubiprostone for the treatment of constipation.
Who cannot join
- Treated with lubiprostone outside of the locally approved label in South Korea.
- Participating in any other clinical study investigating one (or more) of the approved indications of lubiprostone.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326
Site Contact, +82-31-961-7730, drlimyj@gmail.com
Yun Jeong Lim
About this study
Official title: Post-Marketing Surveillance (Usage Results Study) of Adult Patients Treated With Lubiprostone for Indications Approved in South Korea
The main aim of this study is to check the side effects from lubiprostone in adults with constipation. Participants will be treated with lubiprostone according to their clinic's standard practice.
Read the detailed description
This is a prospective, observational post-marketing surveillance study of lubiprostone in participants with constipation. The study will assess the safety and effectiveness of lubiprostone for its approved indication with real-world setting in South Korea.
The study will enroll approximately 3000 participants. The data will be collected prospectively at the study sites will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:
- All Participants
The study will be conducted in South Korea. The overall duration of the study will be approximately 6 years. Data collection will be based on routinely scheduled visits during a 12-month follow up period for each participant up to a final follow-up when the participant discontinues treatment or at the end of follow-up period for any participants still taking lubiprostone.
NOTE: This product was divested from Takeda to Jeil in 2022.
- Conditions
- Constipation
- Being tested
- No Intervention
- Keywords
- Drug Therapy
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Participants diagnosed with constipation who have been prescribed with lubiprostone for the first time in a real-world setting will be observed prospectively and followed up for 12 months after initiation of study medication. Treatment regimen, frequency of laboratory and clinical assessments will be determined by investigator in a routine clinical practice. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting One or More Adverse Events (AEs)
AEs is defined as any undesirable and unintended signs (example, abnormal laboratory values), symptoms, or diseases which occur during or following the administration of the drug, this does not necessarily require causal relationship.
Measured: Up to 12 months
Number of Participants Reporting One or More Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Measured: Up to 12 months
Secondary outcomes (3)
Change From Baseline in the Frequency of Spontaneous Bowel Movement (SBM) at End of Treatment
SBM is a bowel movement occurring in the absence of laxative use. Change from baseline values will be reported for participants who discontinue lubiprostone during study period.
Measured: Baseline up to end of treatment (approximately 12 months)
Time to Resolution of Symptoms After Treatment Discontinuation
Time to resolution of symptoms defined as discontinuation of treatment with lubiprostone.
Measured: Up to 12 months
Change From Baseline in Frequency of SBM After 12-month Follow up
SBM is a bowel movement occurring in the absence of laxative use. Change from baseline values after 12-months follow up period will be reported for participants.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Sep 2021
- Primary completion31 May 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Site Contact, Study director, Jeil Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861233
- Sponsor's protocol ID
- JL-PMS-AM
- Status last verified
- Nov 2022
- First submitted
- 26 Apr 2021
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance (Usage Results Study) of Adult Patients Treated With Lubiprostone for Indications Approved in South Korea
- ClinicalTrials.gov ID
- NCT04861233
- Acronym / sponsor ID
- JL-PMS-AM
- Conditions
- Constipation
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 27 Apr 2021 (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 main aim of this study is to check the side effects from lubiprostone in adults with constipation. Participants will be treated with lubiprostone according to their clinic's standard practice.
Detailed description
This is a prospective, observational post-marketing surveillance study of lubiprostone in participants with constipation. The study will assess the safety and effectiveness of lubiprostone for its approved indication with real-world setting in South Korea.
The study will enroll approximately 3000 participants. The data will be collected prospectively at the study sites will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:
- All Participants
The study will be conducted in South Korea. The overall duration of the study will be approximately 6 years. Data collection will be based on routinely scheduled visits during a 12-month follow up period for each participant up to a final follow-up when the participant discontinues treatment or at the end of follow-up period for any participants still taking lubiprostone.
NOTE: This product was divested from Takeda to Jeil in 2022.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: No InterventionParticipants diagnosed with constipation who have been prescribed with lubiprostone for the first time in a real-world setting will be observed prospectively and followed up for 12 months after initiation of study medication. Treatment regimen, frequency of laboratory and clinical assessments will be determined by investigator in a routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants with first incident prescription for treatment with lubiprostone will be enrolled.
Key inclusion criteria (5 listed)
- South Korean adult.
- With constipation caused by:
- Is newly prescribed (first incident) and initiates lubiprostone for the treatment of constipation.
Key exclusion criteria (2 listed)
- Treated with lubiprostone outside of the locally approved label in South Korea.
- Participating in any other clinical study investigating one (or more) of the approved indications of lubiprostone.
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 |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | All Participants |
Primary outcome
Number of Participants Reporting One or More Adverse Events (AEs)
Time frame: Up to 12 months
AEs is defined as any undesirable and unintended signs (example, abnormal laboratory values), symptoms, or diseases which occur during or following the administration of the drug, this does not necessarily require causal relationship.
Number of Participants Reporting One or More Serious Adverse Events (SAEs)
Time frame: Up to 12 months
A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
3 secondary outcomes
Change From Baseline in the Frequency of Spontaneous Bowel Movement (SBM) at End of Treatment
Time frame: Baseline up to end of treatment (approximately 12 months)
Time to Resolution of Symptoms After Treatment Discontinuation
Time frame: Up to 12 months
Change From Baseline in Frequency of SBM After 12-month Follow up
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Site Contact study director
Jeil Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Jeong Lim, M.D Ph.D (+82-31-961-7730, drlimyj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting One or More Adverse Events (AEs) (time frame: Up to 12 months). The study lists 2 primary outcomes in all. 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 17 Nov 2022.