NCT06317350

Clinical Study to Evaluate the Efficacy and Safety of GNS-212-E in Bowel Preparation for Colonoscopy

A Prospective, Randomized, Parallel, Multi-center, Active Controlled, Single Blind (Assessor), Phase 3 Clinical Trial in Bowel Preparation for Colonoscopy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Gunkang Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial.

Conditions

• Colonoscopy
• Bowel Preparation

Interventions

Type	Name	Description
DRUG	GNS-212-E1	Subjects who are randomized into this group will take GNS-212-E1 from the evening before colonoscopy to the morning of colonoscopy.
DRUG	GNS-212-E2	Subjects who are randomized into this group will take GNS-212-E2 from the evening before colonoscopy to the morning of colonoscopy.
DRUG	GNS-212-ER	Subjects who are randomized into this group will take active control drug (PEG3350) from the evening before colonoscopy to the morning of colonoscopy.

Timeline

• Start date: 2024-03-11
• Primary completion: 2024-10-16
• Completion: 2024-10-16
• First posted: 2024-03-19
• Last updated: 2025-02-19

Locations

1 site across 1 country: South Korea