A Study of Lubiprostone to Treat Constipation

Jeil Pharmaceutical

Status: Enrolling

Conditions: Constipation

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04861233

JL-PMS-AM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 1 patient group

All Participants

Description:

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.

Treatment:

Other: No Intervention