NCT03509220

Safety and Efficacy of PBK-1701TC for Bowel Cleansing Before Colonoscopy

A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK-1701TC

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Pharmbio Korea Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the efficacy, safety and tolerability of PBK-1701TC for bowel cleansing before colonoscopy. Half the participants will receive PBK-1701TC and while the other will receive standard oral preparation.

Detailed description

This study is a prospective, randomized, single-blinded, parallel, 2-treatment, multi-center clinical trial. A total of 224 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 Diseases
• Intestinal Disease
• Gastrointestinal Disease
• Digestive System Disease

Interventions

Type	Name	Description
DRUG	PBK-1701TC	The subject will receive PBK-1701TC for colonoscopy.
DRUG	Standard oral preparation	The subject will receive the standard oral preparation for colonoscopy

Timeline

• Start date: 2018-04-11
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2018-04-26
• Last updated: 2018-11-26

Locations

5 sites across 1 country: South Korea