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

Intestinal Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05249335
• Other study ID #: unconfirmed yet
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 2022
• Est. completion date: February 2024

Study information

• Verified date: December 2021
• Source: Pharmbio Korea Co., Ltd.
• Contact: Cha Jaemyeong, M.D, Ph.D
• Phone: +82-2-440-6113
• Email: clicknox[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Disease
• Colonic Diseases
• Intestinal Disease
• Intestinal Diseases

Intervention

Drug:
• OST
The subject will receive Orafang for colonoscopy
• 2L-PEG/Asc
The subject will receive 2L-PEG/Asc for colonoscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pharmbio Korea Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Adenoma/Polyp detection rate, ADR /PDR	Adenoma/Polyp detection rate over 25%	Two days (from day of first dosing to day of colonoscopy)
Other	clean cecal intubation time, colonoscopy time	clean cecal intubation time, colonoscopy time	Two days (from day of first dosing to day of colonoscopy)
Primary	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)
Primary	Successful cleaning rate2	%Patient with HCS-graded A or B	Two days (from day of first dosing to day of colonoscopy)
Secondary	Treatment compliance	%Patient who have completed taking the investigational products	Two days (from day of first dosing to day of colonoscopy)