Back to resultsA Study to Evaluate Safety and Efficacy of PBK_M2101
Primary Purpose
Intestinal Disease, Colonic Diseases, Gastrointestinal Disease
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PBK_M2101 2-Day
PBK_M2101 1-Day
Oral Sulfate Tablet 2-Day
Sponsored by
About this trial
This is an interventional diagnostic trial for Intestinal Disease
Eligibility Criteria
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
Sites / Locations
- Seoul Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
test 1
test 2
active Comparator
Arm Description
PBK_M2101, 2-Day Regimen
PBK_M2101, 1-Day Regimen
active Comparator, 2-Day Regimen
Outcomes
Primary Outcome Measures
Successful cleansing rate
%Patient with HCS-graded A or B
Secondary Outcome Measures
Overall cleansing rate
%Patient with each HCS-grade (A, B, C, D)
Mean segmental cleansing score
5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.
Mean cecal intubation time
Mean colonoscopy withdrawal time
Treatment compliance
Dosage taken/Dosage scheduled
Patient satisfaction
Subject questionnaire (Taste, Difficulty, Ease of taking)
Polyp detection rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05923918
Brief Title
A Study to Evaluate Safety and Efficacy of PBK_M2101
Official Title
A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2101
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmbio Korea Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Disease, Colonic Diseases, Gastrointestinal Disease, Digestive System Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
246 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
test 1
Arm Type
Experimental
Arm Description
PBK_M2101, 2-Day Regimen
Arm Title
test 2
Arm Type
Experimental
Arm Description
PBK_M2101, 1-Day Regimen
Arm Title
active Comparator
Arm Type
Active Comparator
Arm Description
active Comparator, 2-Day Regimen
Intervention Type
Drug
Intervention Name(s)
PBK_M2101 2-Day
Intervention Description
Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.
Intervention Type
Drug
Intervention Name(s)
PBK_M2101 1-Day
Intervention Description
Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.
Intervention Type
Drug
Intervention Name(s)
Oral Sulfate Tablet 2-Day
Intervention Description
Subjects who are randomized into group active comparative will receive bowel preparation from evening to next morning.
Primary Outcome Measure Information:
Title
Successful cleansing rate
Description
%Patient with HCS-graded A or B
Time Frame
From day of first dosing to day of colonoscopy
Secondary Outcome Measure Information:
Title
Overall cleansing rate
Description
%Patient with each HCS-grade (A, B, C, D)
Time Frame
From day of first dosing to day of colonoscopy
Title
Mean segmental cleansing score
Description
5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.
Time Frame
From day of first dosing to day of colonoscopy
Title
Mean cecal intubation time
Time Frame
From day of first dosing to day of colonoscopy
Title
Mean colonoscopy withdrawal time
Time Frame
From day of first dosing to day of colonoscopy
Title
Treatment compliance
Description
Dosage taken/Dosage scheduled
Time Frame
From day of first dosing to day of colonoscopy
Title
Patient satisfaction
Description
Subject questionnaire (Taste, Difficulty, Ease of taking)
Time Frame
From day of first dosing to day of colonoscopy
Title
Polyp detection rate
Time Frame
From day of first dosing to day of colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manager Clinical Trial team, Pharmbio Korea
Phone
+82-2-587-2551
Email
cr@pharmbio.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byeon, M.D.
Organizational Affiliation
Seoul Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byeon
12. IPD Sharing Statement
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A Study to Evaluate Safety and Efficacy of PBK_M2101
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