Status:
UNKNOWN
A Study of Lubiprostone to Treat Constipation
Lead Sponsor:
Jeil Pharmaceutical Co., Ltd.
Conditions:
Constipation
Eligibility:
All Genders
18+ years
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 app...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT04861233
Start Date
September 1 2021
End Date
November 30 2024
Last Update
November 17 2022
Active Locations (1)
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1
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea, 10326