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

Taejoon Pharmaceutical Co., Ltd.1 site in 1 country297 target enrollmentJanuary 2, 2018

ConditionsBowel Preparation

InterventionsTJP-008-1 TJP-008-2 Coolprep powder

DrugsTJP-008-1 TJP-008-2 Coolprep powder

Overview

Phase: Phase 3
Intervention: TJP-008-1
Conditions: Bowel Preparation
Sponsor: Taejoon Pharmaceutical Co., Ltd.
Enrollment: 297
Locations: 1
Primary Endpoint: Ratio of subjects With successful Bowel Cleansing
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 2, 2018

End Date

July 30, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Taejoon Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.