A Study to Evaluate Safety and Efficacy of PBK_M2101

Sponsor

Pharmbio Korea Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05923918

Collaborator

(none)

246

Enrollment

Location

Arms

Anticipated Duration (Months)

20.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intestinal Disease Colonic Diseases Gastrointestinal Disease Digestive System Disease	Drug: PBK_M2101 2-Day Drug: PBK_M2101 1-Day Drug: Oral Sulfate Tablet 2-Day	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

246 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Successful cleansing rate [From day of first dosing to day of colonoscopy]
%Patient with HCS-graded A or B

Secondary Outcome Measures

Overall cleansing rate [From day of first dosing to day of colonoscopy]
%Patient with each HCS-grade (A, B, C, D)
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.
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 [From day of first dosing to day of colonoscopy]
Dosage taken/Dosage scheduled
Patient satisfaction [From day of first dosing to day of colonoscopy]
Subject questionnaire (Taste, Difficulty, Ease of taking)
Polyp detection rate [From day of first dosing to day of colonoscopy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Pharmbio Korea Co., Ltd.

Investigators

Principal Investigator: Byeon, M.D., Seoul Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pharmbio Korea Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05923918

Other Study ID Numbers:

PBK_M2101_301

First Posted:

Jun 28, 2023

Last Update Posted:

Jun 28, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gastrointestinal Diseases

Digestive System Diseases

Colonic Diseases

Intestinal Diseases

Study Results

No Results Posted as of Jun 28, 2023