A Prospective, Randomized, Single-blinded (Evaluator), Pa... | NCT03544944

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

NCT03544944

Sponsor

Taejoon Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Sep 4, 2019Actual

Enrollment

297Actual

Phase

Phase 3

Conditions

Bowel Preparation

Interventions

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

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2018Actual

Primary Completion Date

May 30, 2018Actual

Completion Date

Jul 30, 2018Actual

First Submitted Date

May 22, 2018

First Submission Date that Met QC Criteria

Jun 1, 2018

First Posted Date

Jun 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2019

Last Update Posted Date

Sep 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

297Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
TJP-008-1	Experimental	Drug: TJP-008-1
TJP-008-2	Experimental	Drug: TJP-008-2
Coolprep powder	Active Comparator	Drug: Coolprep powder

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TJP-008-1	Drug	Subjects who are randomized into group TJP-008-1 will receive bowel preparation on the same-day.	TJP-008-1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taejoon Pharmaceutical Co., Ltd.		Seoul			South Korea