NCT03544944

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

September 4, 2019

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

May 22, 2018

Last Update Submit

September 2, 2019

Conditions

Bowel Preparation

Keywords

bowel preparation

Outcome Measures

Primary Outcomes (1)

  • Ratio of subjects With successful Bowel Cleansing

    1 day of scheduled colonoscopy

Secondary Outcomes (1)

  • Easch segments ratio of subject with successful Bowel Cleansing

    1 day of scheduled colonoscopy

Study Arms (3)

TJP-008-1

EXPERIMENTAL
Drug: TJP-008-1

TJP-008-2

EXPERIMENTAL
Drug: TJP-008-2

Coolprep powder

ACTIVE COMPARATOR
Drug: Coolprep powder

Interventions

TJP-008-1DRUG

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

TJP-008-1
TJP-008-2DRUG

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

TJP-008-2
Coolprep powderDRUG

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

Coolprep powder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must provide written informed consent.
  • Male and female outpatients and inpatients aged: ≥19
  • Patients BMI shoule be ≤ 30

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taejoon Pharmaceutical Co., Ltd.

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 4, 2018

Study Start

January 2, 2018

Primary Completion

May 30, 2018

Study Completion

July 30, 2018

Last Updated

September 4, 2019

Record last verified: 2018-04

Locations

KR(1)