A Study to Evaluate Safety and Efficacy of PBK_M2502
A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2502
1 other identifier
interventional
110
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 P25-P50 for phase_3
Started Aug 2025
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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedFirst Posted
Study publicly available on registry
August 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
August 11, 2025
May 1, 2025
1 year
May 21, 2025
August 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Successful cleansing rate
%Patient with HCS-graded A or B
Day 1 (day of colonoscopy)
Secondary Outcomes (7)
Overall cleansing rate
Day 1 (day of colonoscopy)
Mean segmental cleansing score
Day 1 (day of colonoscopy)
Mean cecal intubation time
Day 1 (day of colonoscopy)
Mean colonoscopy withdrawal time
Day 1 (day of colonoscopy)
Treatment compliance
Day 1 (day of colonoscopy)
- +2 more secondary outcomes
Study Arms (2)
Experimental
EXPERIMENTALPBK\_M2502, 1-Day Regimen
active Comparator
ACTIVE COMPARATORPBK\_M2502, 2-Day Regimen
Interventions
Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.
Subjects who are randomized into group test 1 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)
Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, South Korea
MeSH Terms
Conditions
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 21, 2025
First Posted
August 11, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
August 11, 2025
Record last verified: 2025-05