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NOT YET RECRUITING
NCT07181148
PHASE3

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

Sponsor: Mather's Pharm. Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Kangbuk Samsung Hospital

Seoul, South Korea