NCT07181148

A Study to Evaluate the Safety and Effectiveness of MSP01-T for Bowel Cleansing Before a Colonoscopy

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Mather's Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Detailed description

Colonoscopy is a widely used diagnostic and screening procedure for colorectal diseases. Adequate bowel cleansing is essential for the accuracy and safety of the procedure. MSP01-T is a new bowel cleansing agent developed to improve patient compliance and cleansing quality while minimizing side effects. This phase 3, randomized, single-blind, multicenter, active-controlled, non-inferiority clinical trial is designed to evaluate the efficacy and safety of MSP01-T compared to an existing standard bowel preparation. Participants will be randomly assigned to receive MSP01-T or a comparator product before undergoing a colonoscopy. The primary objective of this study is to assess the quality of bowel preparation as evaluated by endoscopists using a standardized scoring system. Secondary objectives include patient-reported tolerability, safety assessments including adverse events, and overall satisfaction. Adults aged 19 years and older who are scheduled for a colonoscopy may be eligible to participate in this study.

Conditions

• Colonoscopy
• Bowel Preparation

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2025-09-18
• Last updated: 2025-09-25

Locations

1 site across 1 country: South Korea