A Prospective, Randomized, Single-blinded (Evaluator), Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy

Taejoon Pharmaceutical Co., Ltd.297 enrolled

Overview

This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

297

Conditions

Bowel Preparation

Interventions

TJP-008-1DRUG

Subjects who are randomized into group TJP-008-1 will receive bowel preparation on the same-day.

TJP-008-2DRUG

Subjects who are randomized into group TJP-008-2 will receive bowel preparation from evening to next morning.

Coolprep powderDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must provide written informed consent. * Male and female outpatients and inpatients aged: ≥19 * Patients BMI shoule be ≤ 30 Exclusion Criteria: * Patients with past history within last 12 months or current episode of severe constipation * Known glucose-6-phosphate dehydrogenase (G6PD) deficiency. * Known phenylketonuria. * Clinically relevant findings on physical examination based on the Investigator's judgment.

Locations (1)

Taejoon Pharmaceutical Co., Ltd.

Seoul, South Korea

Outcomes

Primary Outcomes

Ratio of subjects With successful Bowel Cleansing

Time frame: 1 day of scheduled colonoscopy

Secondary Outcomes

Easch segments ratio of subject with successful Bowel Cleansing

Time frame: 1 day of scheduled colonoscopy

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.