A Study to Evaluate Safety and Efficacy of PBK_M2502

Not Applicable

Not yet recruiting

• Conditions: Intestinal Disease; Colonic Diseases; Gastrointestinal Disease; Digestive System Disease
• Interventions: Drug: PBK_M2502 1-Day; Drug: PBK_M2502 2-Day

• Registration Number: NCT07114406
• Lead Sponsor: Pharmbio Korea Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-21
• Study Start: 2025-08-01
• Study First Submitted QC: 2025-08-03
• Last Update Submitted: 2025-08-03
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2026-08
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	PBK_M2502 1-Day	PBK_M2502, 1-Day Regimen
active Comparator	PBK_M2502 2-Day	PBK_M2502, 2-Day Regimen

Primary Outcome Measures

Name	Time	Method
Successful cleansing rate	Day 1 (day of colonoscopy)	%Patient with HCS-graded A or B

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Gangdong-gu, Korea, Republic of