Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07114406

A Study to Evaluate Safety and Efficacy of PBK_M2502

This clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kyung Hee University Hospital at Gangdong

Seoul, Gangdong-gu, South Korea

Location contact

Cha Jaemyung, Principal Investigator

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PBK_M2502 1-Day

Drug

Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.

PBK_M2502 2-Day

Drug

Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.

Primary outcomes

  1. Successful cleansing rate

    Time frame: Day 1 (day of colonoscopy)

    %Patient with HCS-graded A or B

Secondary outcomes

  1. Overall cleansing rate

    Time frame: Day 1 (day of colonoscopy)

    %Patient with each HCS-grade (A, B, C, D)

  2. Mean segmental cleansing score

    Time frame: Day 1 (day of colonoscopy)

    5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.

  3. Mean cecal intubation time

    Time frame: Day 1 (day of colonoscopy)

  4. Mean colonoscopy withdrawal time

    Time frame: Day 1 (day of colonoscopy)

  5. Treatment compliance

    Time frame: Day 1 (day of colonoscopy)

    Dosage taken/Dosage scheduled

  6. Patient satisfaction

    Time frame: Day 1 (day of colonoscopy)

    Subject questionnaire (Taste, Difficulty, Ease of taking)

  7. Polyp detection rate

    Time frame: Day 1 (day of colonoscopy)

Study contacts

Contact information is provided by the study sponsor or research team.

Manager Clinical Trial team, Pharmbio Korea

CONTACT

[email protected]

+82-2-587-2551

Sponsors and collaborators

Lead sponsor

Pharmbio Korea Co., Ltd.

Industry

Registry information

Official study title

A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2502

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.