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

Pharmbio Korea

Status and phase: Unknown; Phase 4

Conditions: Intestinal Disease; Colonic Disease

Treatments: Drug: 2L-PEG/Asc; Drug: OST

Study type: Interventional

Funder types: Industry

Identifiers

NCT05249335

unconfirmed yet

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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256 participants in 2 patient groups

OST

Experimental group

Description:

2 days split dosing regimen

Treatment:

Drug: OST

2L-PEG/Asc

Active Comparator group

Description:

2 days split dosing regimen

Treatment:

Drug: 2L-PEG/Asc