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Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly

Primary Purpose

Colonic Disease, Intestinal Disease

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

OST

2L-PEG/Asc

About this trial

This is an interventional diagnostic trial for Colonic Disease focused on measuring colonoscopy, orafang, bowel cleaning

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

age over 70
Patients who is scheduled a colonoscopy
Patients who is informed and give a consent in voluntary

Exclusion Criteria:

History of colectomy
Patients over American Society of Anesthesiology class III
Patients who has difficulty swallowing
In the case of abnormal findings requiring treatment in the basic blood test
Patients with uncontrollable chronic diseases
Patients suspected of having Paralytic ileus or intestinal obstruction.
Patients who complains of alarm sign (severe abdominal pain, weight loss, anemia, gastrointestinal bleeding, etc.)
Patients who has a history of drug abuse and addiction
Patients who for any reason, are deemed by the Investigator to be inappropriate for this study

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OST

2L-PEG/Asc

Arm Description

2 days split dosing regimen

Outcomes

Primary Outcome Measures

Successful cleaning rate1

%Patient with Boston Bowel Preparation Scale (BBPS) scored over 2 in all segment

Successful cleaning rate2

%Patient with HCS-graded A or B

Secondary Outcome Measures

Treatment compliance

%Patient who have completed taking the investigational products

Full Information

NCT ID

NCT05249335

First Posted

January 3, 2022

Last Updated

February 9, 2022

Sponsor

Pharmbio Korea Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05249335

Brief Title

Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly

Official Title

Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly: Multicenter, Prospective, Investigator Single-blinded, Randomized Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 2022 (Anticipated)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharmbio Korea Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study compares the effectiveness and stability of intestinal tablet (OST), an oral sulfate table (OST), developed in the form of pills, with 2L-PEG/Asc for examinees aged 70 or older who are scheduled for colonoscopy.

Detailed Description

This study is comparison for efficacy and safety of bowel preparation between oral sulfate table and 2L-polyethylene glycol/ascorbate in elderly: multicenter, prospective, investigator single-blinded, randomized study. A total of 256 subjects will participate to this study and be assigned to the test group or the control group. The subject will administer the first dose of assigned investigational product in the evening prior to the scheduled colonoscopy. Subject will take the second dose early in the morning of the colonoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colonic Disease, Intestinal Disease

Keywords

colonoscopy, orafang, bowel cleaning

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

multicenter, prospective, investigator single-blinded, randomized study

Masking

Investigator

Allocation

Randomized

Enrollment

256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OST

Arm Type

Experimental

Arm Description

2 days split dosing regimen

Arm Title

2L-PEG/Asc

Arm Type

Active Comparator

Arm Description

2 days split dosing regimen

Intervention Type

Drug

Intervention Name(s)

OST

Intervention Description

The subject will receive Orafang for colonoscopy

Intervention Type

Drug

Intervention Name(s)

2L-PEG/Asc

Intervention Description

The subject will receive 2L-PEG/Asc for colonoscopy

Primary Outcome Measure Information:

Title

Successful cleaning rate1

Description

%Patient with Boston Bowel Preparation Scale (BBPS) scored over 2 in all segment

Time Frame

Two days (from day of first dosing to day of colonoscopy)

Title

Successful cleaning rate2

Description

%Patient with HCS-graded A or B

Time Frame

Two days (from day of first dosing to day of colonoscopy)

Secondary Outcome Measure Information:

Title

Treatment compliance

Description

%Patient who have completed taking the investigational products

Time Frame

Two days (from day of first dosing to day of colonoscopy)

Other Pre-specified Outcome Measures:

Title

Patient satisfaction assessed by questionnaire

Description

maximum score 10, minimum score0 , higher scores mean a better satisfaction

Time Frame

Two days (from day of first dosing to day of colonoscopy)

Title

Adenoma/Polyp detection rate, ADR /PDR

Description

Adenoma/Polyp detection rate over 25%

Time Frame

Two days (from day of first dosing to day of colonoscopy)

Title

clean cecal intubation time, colonoscopy time

Description

clean cecal intubation time, colonoscopy time

Time Frame

Two days (from day of first dosing to day of colonoscopy)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age over 70 Patients who is scheduled a colonoscopy Patients who is informed and give a consent in voluntary Exclusion Criteria: History of colectomy Patients over American Society of Anesthesiology class III Patients who has difficulty swallowing In the case of abnormal findings requiring treatment in the basic blood test Patients with uncontrollable chronic diseases Patients suspected of having Paralytic ileus or intestinal obstruction. Patients who complains of alarm sign (severe abdominal pain, weight loss, anemia, gastrointestinal bleeding, etc.) Patients who has a history of drug abuse and addiction Patients who for any reason, are deemed by the Investigator to be inappropriate for this study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cha Jaemyeong, M.D, Ph.D

Phone

+82-2-440-6113

clicknox@hanmail.net

First Name & Middle Initial & Last Name or Official Title & Degree

Yoon Jinyeong

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cha Jaemyeong, M.D, Ph.D

Organizational Affiliation

Kyung Hee University Hospital at Gangdong

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Gang Hoseok, M.D, Ph.D

Organizational Affiliation

HALLYM UNIV. MEDICAL CENTER

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Seo Geomseok, M.D, Ph.D

Organizational Affiliation

Wonkwang University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jeong Yunho, M.D, Ph.D

Organizational Affiliation

Soon Chun Hanyang University College of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Na Suyeong, M.D, Ph.D

Organizational Affiliation

Incheon St.Mary's Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly

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