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

NCT07181148 | Not Yet Recruiting Phase 3

• 1 other identifier: MTS-P01-2401
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colonoscopy; Bowel Preparation

Keywords

MSP01-T; Colonoscopy; Colon Cleanse; Oral Bowel Cleanser; Oral Tablet; Randomized Trial; Phase 3 Study

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with "successful" bowel cleansing based on HCS [by independent central reader]

  Percentage of participants assessed as having "successful" bowel preparation by independent central reader based on Harefield Cleansing Scale (HCS). "Successful" = HCS grade A or B.

  During colonoscopy

Secondary Outcomes (16)

• Proportion of participants with "successful" bowel cleansing based on HCS [by investigator]

  During colonoscopy

• Overall bowel cleansing score based on HCS [by independent central reader]

  During colonoscopy

• Overall bowel cleansing score based on HCS [by investigator]

  During colonoscopy

• Segmental bowel cleansing scores (5 colonic segments) based on HCS [by independent central reader]

  During colonoscopy

• Segmental bowel cleansing scores (5 colonic segments) based on HCS [by investigator]

  During colonoscopy

Study Arms (2)

Test Drug Group

EXPERIMENTAL

2-day split-dose

Drug: MSP01-T

Control Drug Group

ACTIVE COMPARATOR

2-day split-dose

Drug: MSP01-R

Interventions

MSP01-R DRUG

Total 20 tablets, split-dose administration over 2 days: 14 tablets the day before colonoscopy, 14 tablets on the morning of colonoscopy, oral intake.

Also known as: Orafang Tab

Control Drug Group

MSP01-T DRUG

Total 20 tablets, split-dose administration over 2 days: 10 tablets the day before colonoscopy, 10 tablets on the morning of colonoscopy, oral intake.

Test Drug Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged 19 years or older at the time of providing written informed consent.
• Individuals scheduled to undergo a screening colonoscopy.
• kg/㎡ ≤ BMI \< 30 kg/㎡
• Participants who have voluntarily agreed to participate in the clinical trial and have provided written informed consent.

You may not qualify if:

• Participants who meet any of the following will NOT be eligible to participate in this clinical trial:
• Colonoscopy for therapeutic purposes, including:
• Hemostatic treatment after vascular malformation, ulcer, tumor, or polypectomy
• Decompression for non-toxic megacolon or sigmoid volvulus
• Foreign body removal
• Balloon dilation of strictures
• Palliative treatment for bleeding due to strictures or tumors
• Medical history at screening, including:
• Epilepsy or seizure within 2 years
• Severe cardiac disease within 24 weeks (e.g., unstable angina, acute myocardial infarction)
• Clinically significant gastrointestinal or abdominal surgery within 24 weeks (except appendectomy, hemorrhoidectomy)
• Active infection or fever ≥ 38°C within 1 week (except mild upper respiratory infection or localized skin infection)
• Hypersensitivity to investigational product components
• Concomitant diseases at screening, including:
• Active gastrointestinal bleeding

Sponsors & Collaborators

• Mather's Pharm. Co., Ltd.: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 18, 2025
• Study Start: October 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)