A Study to Evaluate Safety and Efficacy of PBK_M2101

Gastrointestinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05923918
• Other study ID #: PBK_M2101_301
• Status: Recruiting
• Phase: Phase 3
• Start date: June 2023
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: Pharmbio Korea Co., Ltd.
• Contact: Manager Clinical Trial team, Pharmbio Korea
• Phone: +82-2-587-2551
• Email: cr[@]pharmbio.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Diseases
• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Intestinal Disease
• Intestinal Diseases

Intervention

Drug:
• PBK_M2101 2-Day
Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.
• PBK_M2101 1-Day
Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.
• Oral Sulfate Tablet 2-Day
Subjects who are randomized into group active comparative will receive bowel preparation from evening to next morning.

Locations

Country	Name	City	State
Korea, Republic of	Seoul Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pharmbio Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful cleansing rate	%Patient with HCS-graded A or B	From day of first dosing to day of colonoscopy
Secondary	Overall cleansing rate	%Patient with each HCS-grade (A, B, C, D)	From day of first dosing to day of colonoscopy
Secondary	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
Secondary	Mean cecal intubation time		From day of first dosing to day of colonoscopy
Secondary	Mean colonoscopy withdrawal time		From day of first dosing to day of colonoscopy
Secondary	Treatment compliance	Dosage taken/Dosage scheduled	From day of first dosing to day of colonoscopy
Secondary	Patient satisfaction	Subject questionnaire (Taste, Difficulty, Ease of taking)	From day of first dosing to day of colonoscopy
Secondary	Polyp detection rate		From day of first dosing to day of colonoscopy