A Study to Evaluate Safety and Efficacy of PBK_M2101 | NCT05923918

Studies
A Study to Evaluate Safety and Efficacy of PBK_M2101

NCT05923918

Sponsor

Pharmbio Korea Co., Ltd.

Status

Unknown status

Last Update Posted

Jun 28, 2023Actual

Enrollment

246Estimated

Phase

Phase 3

Conditions

Intestinal Disease
Colonic Diseases
Gastrointestinal Disease
Digestive System Disease

Interventions

PBK_M2101 2-Day
PBK_M2101 1-Day
Oral Sulfate Tablet 2-Day

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

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2023Estimated

Primary Completion Date

May 2024Estimated

Completion Date

Jun 2024Estimated

First Submitted Date

May 18, 2023

First Submission Date that Met QC Criteria

Jun 20, 2023

First Posted Date

Jun 28, 2023Actual

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

Jun 20, 2023

Last Update Posted Date

Jun 28, 2023Actual

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 clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.

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

246Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
test 1	Experimental	PBK_M2101, 2-Day Regimen	Drug: PBK_M2101 2-Day
test 2	Experimental	PBK_M2101, 1-Day Regimen	Drug: PBK_M2101 1-Day
active Comparator	Active Comparator	active Comparator, 2-Day Regimen	Drug: Oral Sulfate Tablet 2-Day

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PBK_M2101 2-Day	Drug	Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.	test 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful cleansing rate	%Patient with HCS-graded A or B	From day of first dosing to day of colonoscopy

Secondary Outcomes

Measure	Description	Time Frame
Overall cleansing rate	%Patient with each HCS-grade (A, B, C, D)	From day of first dosing to day of colonoscopy
Mean segmental cleansing score	5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who is informed and give a consent in voluntary
Patients who is scheduled a esophagogastroduodenoscopy and colonoscopy
BMI 19≤and<30

Exclusion Criteria:

Patients who participate in other interventional study or had participated within 30 days before screening
Pregnant or breast-feeding women who do not want to stop breast-feeding
Uncontrolled hypertension
Uncontrolled diabetes
Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance
HIV infection and/or chronic hepatitis B or C
Patients who has a difficulty to participate because of severe nausea or vomiting
History of colon surgery and abdominal surgery within 6 month; need an emergency surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Manager Clinical Trial team, Pharmbio Korea	Contact	+82-2-587-2551		cr@pharmbio.co.kr

Overall Officials

Name	Affiliation	Role
Byeon, M.D.	Seoul Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul Asan Medical Center	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D007410	Intestinal Diseases
D003108	Colonic Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013431	Sulfates

Ancestor Terms

ID	Term
D000838	Anions
D007477	Ions
D004573	Electrolytes
D007287	Inorganic Chemicals
D013464

Browse Leaves

Not provided

Browse Branches

Not provided