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A Study to Evaluate the Safety and Effectiveness of MSP01-T for Bowel Cleansing Before a Colonoscopy
Sponsor: Mather's Pharm. Co., Ltd.
Summary
This study is being conducted to evaluate the safety and effectiveness of MSP01-T, a new bowel cleansing agent, in adults who are scheduled to undergo a colonoscopy. Participants will be randomly assigned to receive either MSP01-T or a comparator product. The study will assess how effectively MSP01-T cleans the bowel before the procedure and monitor any potential side effects. Adults aged 19 years and older who are planning to have a colonoscopy may be eligible to take part.
Official title: A Prospective, Randomized, Single-blinded (Investigator), Parallel, Multi-center, Active-control, Non-inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of MSP01-T for Bowel Cleansing Before Colonoscopy
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
214
Start Date
2025-10
Completion Date
2026-05
Last Updated
2025-09-25
Healthy Volunteers
Yes
Conditions
Interventions
MSP01-R
Total 20 tablets, split-dose administration over 2 days: 14 tablets the day before colonoscopy, 14 tablets on the morning of colonoscopy, oral intake.
MSP01-T
Total 20 tablets, split-dose administration over 2 days: 10 tablets the day before colonoscopy, 10 tablets on the morning of colonoscopy, oral intake.
Locations (1)
Kangbuk Samsung Hospital
Seoul, South Korea