A Study to Evaluate Safety and Efficacy of PBK_M2101

A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2101

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: Recruiting
• Conditions: Colonic Diseases; Digestive System Disease; Gastrointestinal Disease; Intestinal Disease
• Intervention / Treatment: Drug: PBK_M2101 2-Day; Drug: PBK_M2101 1-Day; Drug: Oral Sulfate Tablet 2-Day

• Study Type: Interventional
• Enrollment (Estimated): 246
• Phase: Phase 3

Contacts and Locations

• 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
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul Asan Medical Center
    • Principal Investigator: Byeon

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test 1; PBK_M2101, 2-Day Regimen	Drug: PBK_M2101 2-Day; Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.
Experimental: test 2; PBK_M2101, 1-Day Regimen	Drug: PBK_M2101 1-Day; Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.
Active Comparator: active Comparator; active Comparator, 2-Day Regimen	Drug: Oral Sulfate Tablet 2-Day; Subjects who are randomized into group active comparative 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	%Patient with HCS-graded A or B	From day of first dosing to day of colonoscopy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pharmbio Korea Co., Ltd.
• Investigators: Principal Investigator: Byeon, M.D., Seoul Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases
• Other Study ID Numbers: PBK_M2101_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