A Study to Evaluate Safety and Efficacy of PBK_M2101

Phase 3

Recruiting

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

• Registration Number: NCT05923918
• 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

• Study First Submitted: 2023-05-18
• Status Verified: 2023-06
• Study Start: 2023-06
• Study First Submitted QC: 2023-06-20
• Last Update Submitted: 2023-06-20
• Study First Posted: 2023-06-28
• Last Update Posted: 2023-06-28
• Primary Completion: 2024-05
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 246

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
active Comparator	Oral Sulfate Tablet 2-Day	active Comparator, 2-Day Regimen
test 2	PBK_M2101 1-Day	PBK_M2101, 1-Day Regimen
test 1	PBK_M2101 2-Day	PBK_M2101, 2-Day Regimen

Primary Outcome Measures

Name	Time	Method
Successful cleansing rate	From day of first dosing to day of colonoscopy	%Patient with HCS-graded A or B

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of