A Study of Lubiprostone to Treat Constipation

Constipation Clinical Trial

Official title:

Post-Marketing Surveillance (Usage Results Study) of Adult Patients Treated With Lubiprostone for Indications Approved in South Korea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04861233
• Other study ID #: JL-PMS-AM
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: November 2022
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: Yun Jeong Lim, M.D Ph.D
• Phone: +82-31-961-7730
• Email: drlimyj[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: November 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. South Korean adult.

2. 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.

3. Is newly prescribed (first incident) and initiates lubiprostone for the treatment of constipation.

Exclusion Criteria:

1. Treated with lubiprostone outside of the locally approved label in South Korea.

2. Participating in any other clinical study investigating one (or more) of the approved indications of lubiprostone.

Related Conditions & MeSH terms

• Constipation

Intervention

Other:
• No Intervention
This is a non-interventional study.

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Baseline up to end of treatment (approximately 12 months)
Secondary	Time to Resolution of Symptoms After Treatment Discontinuation	Time to resolution of symptoms defined as discontinuation of treatment with lubiprostone.	Up to 12 months
Secondary	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.	Up to 12 months

External Links

•   To obtain more information on the study, click here/on this link