A Study of Lubiprostone to Treat Constipation
Post-Marketing Surveillance (Usage Results Study) of Adult Patients Treated With Lubiprostone for Indications Approved in South Korea
1 other identifier
observational
3,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2021
CompletedFirst Posted
Study publicly available on registry
April 27, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedNovember 17, 2022
November 1, 2022
2.7 years
April 26, 2021
November 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Up to 12 months
Secondary Outcomes (3)
Change From Baseline in the Frequency of Spontaneous Bowel Movement (SBM) at End of Treatment
Baseline up to end of treatment (approximately 12 months)
Time to Resolution of Symptoms After Treatment Discontinuation
Up to 12 months
Change From Baseline in Frequency of SBM After 12-month Follow up
Up to 12 months
Study Arms (1)
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.
Interventions
Eligibility Criteria
Eligible participants with first incident prescription for treatment with lubiprostone will be enrolled.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326, South Korea
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Site Contact
Jeil Pharmaceutical Co., Ltd.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2021
First Posted
April 27, 2021
Study Start
September 1, 2021
Primary Completion
May 31, 2024
Study Completion
November 30, 2024
Last Updated
November 17, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share