A Study to Evaluate Safety and Efficacy of PBK_M2101
A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2101
1 other identifier
interventional
246
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2023
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedJune 28, 2023
June 1, 2023
11 months
May 18, 2023
June 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Successful cleansing rate
%Patient with HCS-graded A or B
From day of first dosing to day of colonoscopy
Secondary Outcomes (7)
Overall cleansing rate
From day of first dosing to day of colonoscopy
Mean segmental cleansing score
From day of first dosing to day of colonoscopy
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
- +2 more secondary outcomes
Study Arms (3)
test 1
EXPERIMENTALPBK\_M2101, 2-Day Regimen
test 2
EXPERIMENTALPBK\_M2101, 1-Day Regimen
active Comparator
ACTIVE COMPARATORactive Comparator, 2-Day Regimen
Interventions
Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.
Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.
Subjects who are randomized into group active comparative will receive bowel preparation from evening to next morning.
Eligibility Criteria
You may qualify if:
- Patients who is informed and give a consent in voluntary
- Patients who is scheduled a esophagogastroduodenoscopy and colonoscopy
- BMI 19≤and\<30
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul Asan Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Byeon, M.D.
Seoul Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2023
First Posted
June 28, 2023
Study Start
June 1, 2023
Primary Completion
May 1, 2024
Study Completion
June 1, 2024
Last Updated
June 28, 2023
Record last verified: 2023-06