Clinical trial NCT04861233: A Study of Lubiprostone to Treat Constipation
Official title: Post-Marketing Surveillance (Usage Results Study) of Adult Patients Treated With Lubiprostone for Indications Approved in South Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Constipation
Keywords: Drug Therapy
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants with first incident prescription for treatment with lubiprostone will be enrolled.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Reporting One or More Adverse Events (AEs)
timeFrame: Up to 12 months
measure: Number of Participants Reporting One or More Serious Adverse Events (SAEs)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Change From Baseline in the Frequency of Spontaneous Bowel Movement (SBM) at End of Treatment
timeFrame: Baseline up to end of treatment (approximately 12 months)
measure: Time to Resolution of Symptoms After Treatment Discontinuation
timeFrame: Up to 12 months
measure: Change From Baseline in Frequency of SBM After 12-month Follow up
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
state: Gyeonggi-do
Study officials:
affiliation: Jeil Pharmaceutical Co., Ltd.
name: Site Contact
role: STUDY_DIRECTOR
References: