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
Sponsored by
About this trial
This is an interventional diagnostic trial for Colonic Disease focused on measuring colonoscopy, orafang, bowel cleaning
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
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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
Email
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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