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

Phase 4

• Conditions: Intestinal Disease; Colonic Disease
• Interventions: Drug: OST; Drug: 2L-PEG/Asc

• Registration Number: NCT05249335
• Lead Sponsor: Pharmbio Korea Co., Ltd.

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.

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2022-01-03
• Study Start: 2022-02
• Study First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Study First Posted: 2022-02-21
• Last Update Posted: 2022-02-21
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 256

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OST	OST	2 days split dosing regimen
2L-PEG/Asc	2L-PEG/Asc	2 days split dosing regimen

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Treatment compliance	Two days (from day of first dosing to day of colonoscopy)	%Patient who have completed taking the investigational products