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

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.

Study Overview

• Status: Recruiting
• Conditions: Constipation
• Intervention / Treatment: Other: No Intervention

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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Yun Jeong Lim, M.D Ph.D; Phone Number: +82-31-961-7730; Email: drlimyj@gmail.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10326
      • Recruiting
      • Dongguk University Ilsan Hospital
      • Contact: Site Contact; Phone Number: +82-31-961-7730; Email: drlimyj@gmail.com
      • Principal Investigator: Yun Jeong Lim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants with first incident prescription for treatment with lubiprostone will be enrolled.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No Intervention; This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Time to Resolution of Symptoms After Treatment Discontinuation	Time to resolution of symptoms defined as discontinuation of treatment with lubiprostone.	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.
• Investigators: Study Director: Site Contact, Jeil Pharmaceutical Co., Ltd.

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: JL-PMS-AM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No