A Study to Evaluate Safety and Efficacy of PBK_M2502

August 3, 2025 updated by: Pharmbio Korea Co., Ltd.

A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2502

This clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Manager Clinical Trial team, Pharmbio Korea
  • Phone Number: +82-2-587-2551
  • Email: cr@pharmbio.co.kr

Study Locations

  • Korea, Republic of
    • Gangdong-gu
      • Seoul, Gangdong-gu, Korea, Republic of
        • Kyung Hee University Hospital at Gangdong
        • Principal Investigator:
          • Cha Jaemyung, Principal Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients who is informed and give a consent in voluntary
  • Patients who is scheduled a esophagogastroduodenoscopy and colonoscopy
  • BMI 19≤and<30

Exclusion Criteria:

  • Patients who participate in other interventional study or had participated within 30 days before screening
  • Pregnant or breast-feeding women who do not want to stop breast-feeding
  • Uncontrolled hypertension
  • Uncontrolled diabetes
  • Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance
  • HIV infection and/or chronic hepatitis B or C
  • Patients who has a difficulty to participate because of severe nausea or vomiting
  • History of colon surgery and abdominal surgery within 6 month; need an emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
PBK_M2502, 1-Day Regimen
Drug: PBK_M2502 1-Day
Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.
Active Comparator: active Comparator
PBK_M2502, 2-Day Regimen
Drug: PBK_M2502 2-Day
Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful cleansing rate
Time Frame: Day 1 (day of colonoscopy)
%Patient with HCS-graded A or B
Day 1 (day of colonoscopy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall cleansing rate
Time Frame: Day 1 (day of colonoscopy)
%Patient with each HCS-grade (A, B, C, D)
Day 1 (day of colonoscopy)
Mean segmental cleansing score
Time Frame: Day 1 (day of colonoscopy)
5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.
Day 1 (day of colonoscopy)
Mean cecal intubation time
Time Frame: Day 1 (day of colonoscopy)
Day 1 (day of colonoscopy)
Mean colonoscopy withdrawal time
Time Frame: Day 1 (day of colonoscopy)
Day 1 (day of colonoscopy)
Treatment compliance
Time Frame: Day 1 (day of colonoscopy)
Dosage taken/Dosage scheduled
Day 1 (day of colonoscopy)
Patient satisfaction
Time Frame: Day 1 (day of colonoscopy)
Subject questionnaire (Taste, Difficulty, Ease of taking)
Day 1 (day of colonoscopy)
Polyp detection rate
Time Frame: Day 1 (day of colonoscopy)
Day 1 (day of colonoscopy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmbio Korea Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

May 21, 2025

First Submitted That Met QC Criteria

August 3, 2025

First Posted (Actual)

August 11, 2025

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 3, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBK_M2502_301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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