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

Phase 3

Completed

• Conditions: Bowel Preparation
• Interventions: Drug: TJP-008-2; Drug: TJP-008-1; Drug: Coolprep powder

• Registration Number: NCT03544944
• Lead Sponsor: Taejoon Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Status Verified: 2018-04
• Study First Submitted: 2018-05-22
• Primary Completion: 2018-05-30
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-04
• Study Completion: 2018-07-30
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 297

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TJP-008-2	TJP-008-2	-
TJP-008-1	TJP-008-1	-
Coolprep powder	Coolprep powder	-

Primary Outcome Measures

Name	Time	Method
Ratio of subjects With successful Bowel Cleansing	1 day of scheduled colonoscopy

Secondary Outcome Measures

Name	Time	Method
Easch segments ratio of subject with successful Bowel Cleansing	1 day of scheduled colonoscopy

Trial Locations

Locations (1)

Taejoon Pharmaceutical Co., Ltd.; 🇰🇷 Seoul, Korea, Republic of