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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
Sponsored by
Pharmbio Korea Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

    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

    First Posted
    January 3, 2022
    Last Updated
    February 9, 2022
    Sponsor
    Pharmbio Korea Co., Ltd.
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    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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