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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intestinal Disease; Colonic Disease
• Intervention / Treatment: Drug: OST; Drug: 2L-PEG/Asc

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.

• Study Type: Interventional
• Enrollment (Anticipated): 256
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Cha Jaemyeong, M.D, Ph.D; Phone Number: +82-2-440-6113; Email: clicknox@hanmail.net
• Study Contact Backup: Name: Yoon Jinyeong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OST; 2 days split dosing regimen	Drug: OST; The subject will receive Orafang for colonoscopy
Active Comparator: 2L-PEG/Asc; 2 days split dosing regimen	Drug: 2L-PEG/Asc; The subject will receive 2L-PEG/Asc for colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful cleaning rate1	%Patient with Boston Bowel Preparation Scale (BBPS) scored over 2 in all segment	Two days (from day of first dosing to day of colonoscopy)
Successful cleaning rate2	%Patient with HCS-graded A or B	Two days (from day of first dosing to day of colonoscopy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment compliance	%Patient who have completed taking the investigational products	Two days (from day of first dosing to day of colonoscopy)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction assessed by questionnaire	maximum score 10, minimum score0 , higher scores mean a better satisfaction	Two days (from day of first dosing to day of colonoscopy)
Adenoma/Polyp detection rate, ADR /PDR	Adenoma/Polyp detection rate over 25%	Two days (from day of first dosing to day of colonoscopy)
clean cecal intubation time, colonoscopy time	clean cecal intubation time, colonoscopy time	Two days (from day of first dosing to day of colonoscopy)

Collaborators and Investigators

• Sponsor: Pharmbio Korea Co., Ltd.
• Investigators: Study Chair: Cha Jaemyeong, M.D, Ph.D, Kyung Hee University Hospital at Gangdong; Principal Investigator: Gang Hoseok, M.D, Ph.D, Hallym Univ. Medical Center; Principal Investigator: Seo Geomseok, M.D, Ph.D, Wonkwang University Hospital; Principal Investigator: Jeong Yunho, M.D, Ph.D, Soon Chun Hanyang University College of Medicine; Principal Investigator: Na Suyeong, M.D, Ph.D, Incheon St.Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: colonoscopy; orafang; bowel cleaning
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases
• Other Study ID Numbers: unconfirmed yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No