NCT05249335

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Pharmbio Korea Co., Ltd. · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colonic Disease
• Intestinal Disease

Interventions

Type	Name	Description
DRUG	OST	The subject will receive Orafang for colonoscopy
DRUG	2L-PEG/Asc	The subject will receive 2L-PEG/Asc for colonoscopy

Timeline

• Start date: 2022-02-01
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2022-02-21
• Last updated: 2022-02-21