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Not yet recruiting NCT07114406

A Study to Evaluate Safety and Efficacy of PBK_M2502

Phase III Interventional Intestinal Disease Colonic Diseases Gastrointestinal Disease Digestive System Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PBK_M2502 1-Day, PBK_M2502 2-Day.
Who it may be relevant to
Registry conditions: Intestinal Disease, Colonic Diseases, Gastrointestinal Disease, Digestive System Disease. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug PBK_M2502 1-Day
    Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.
  • Drug PBK_M2502 2-Day
    Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.

Primary outcome measures

  • Successful cleansing rate [Time frame: Day 1 (day of colonoscopy)]
Secondary outcome measures (7)
  • Overall cleansing rate [Time frame: Day 1 (day of colonoscopy)]
  • Mean segmental cleansing score [Time frame: Day 1 (day of colonoscopy)]
  • Mean cecal intubation time [Time frame: Day 1 (day of colonoscopy)]
  • Mean colonoscopy withdrawal time [Time frame: Day 1 (day of colonoscopy)]
  • Treatment compliance [Time frame: Day 1 (day of colonoscopy)]
  • Patient satisfaction [Time frame: Day 1 (day of colonoscopy)]
  • Polyp detection rate [Time frame: Day 1 (day of colonoscopy)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

South Korea · 1 center
  • Kyung Hee University Hospital at Gangdong — Seoul

Identifiers

NCT: NCT07114406 · PBK_M2502_301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗