Clinical trial

A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2101

Name

PBK_M2101_301

Description

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 arms

Trial start

2023-06-01

Estimated PCD

2024-05-01

Trial end

2024-06-01

Status

Recruiting

Phase

Early phase I

Treatment

PBK_M2101 2-Day

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

Arms:

test 1

PBK_M2101 1-Day

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

Arms:

test 2

Oral Sulfate Tablet 2-Day

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

Arms:

active Comparator

Size

246

Primary endpoint

Successful cleansing rate

From day of first dosing to 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 246, 'type': 'ESTIMATED'}}

Updated at

2023-06-28

1 organization

2 products

4 indications

Organization

Product

Indication

Indication

Indication

Gastrointestinal Disease

Indication

Digestive System Disease

Product

Oral Sulfate Tablet