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

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

Study Overview

• Status: Completed
• Conditions: Bowel Preparation
• Intervention / Treatment: Drug: TJP-008-1; Drug: TJP-008-2; Drug: Coolprep powder

• Study Type: Interventional
• Enrollment (Actual): 297
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Taejoon Pharmaceutical Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TJP-008-1	Drug: TJP-008-1; Subjects who are randomized into group TJP-008-1 will receive bowel preparation on the same-day.
Experimental: TJP-008-2	Drug: TJP-008-2; Subjects who are randomized into group TJP-008-2 will receive bowel preparation from evening to next morning.
Active Comparator: Coolprep powder	Drug: Coolprep powder; Subjects who are randomized into group Coolprep will receive bowel preparation from evening to next morning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ratio of subjects With successful Bowel Cleansing	1 day of scheduled colonoscopy

Secondary Outcome Measures

Outcome Measure	Time Frame
Easch segments ratio of subject with successful Bowel Cleansing	1 day of scheduled colonoscopy

Collaborators and Investigators

• Sponsor: Taejoon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 2, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: bowel preparation
• Other Study ID Numbers: TJP-008-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No