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

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

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

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Bowel Preparation
• Intervention / Treatment: Drug: GNS-212-E1; Drug: GNS-212-E2; Drug: GNS-212-ER

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult men and women between 19 years and 79 age or older as of the date of consent in writing
2. 19 kg/㎡ ≤ BMI < 30 kg/㎡
3. a prospective colonoscopy patient

4. For women of childbearing potential, those who agree to use a medically acceptable contraceptive method* during the clinical trial period

   *hormonal contraceptive, implantation of intrauterine device or intrauterine system, Infertility procedures/surgery (e.g., bilateral ovarian ligation, vasectomy)

5. A person who voluntarily agrees to participate in this clinical trial and signs a written agreement Abbreviation
6. Women of childbearing potential must have a negative serum or urine pregnancy test before Investigational Product administration

Exclusion Criteria:

1. A person having constipation who is regularly administered laxatives or gastrointestinal motility promoters
2. A person with a history of significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection
3. A person diagnosed with acute coronary disease, arrhythmia, cardiomyopathy, cardiac valvular disease, aortic and peripheral vascular disease
4. Active infection or high fever above 38°C
5. Uncontrolled chronic medical illnesses or suspected symptoms that hinder participation such as major cardiac, renal, and metabolic (ex, Subjects with severe renal disease).
6. Clinically significant abnormal laboratory values of screening.(Creatinine, AST or ALT )
7. Active hepatitis B or hepatitis C with positive HBsAg and HCV Ab tests at screening
8. Positive for Human Immuno-deficiency Virus (HIV) at the time of screening
9. Severe nausea or vomiting
10. Severe abdominal distension or abdominal pain
11. A person prone to aspiration or reflux
12. A person who undergoes colonoscopy for the following therapeutic purpose (1) balloon dilatation of the stenosis area (2) non-toxic giant colon or decompression of the S-phase colitis (sigmoid volvulus) (3) Removal of foreign substances (4) Vascular dysplasia, ulcer, tumor and treatment of bleeding after polypectomy
13. A person who is hypersensitive to the ingredients of a clinical trial drug
14. Pregnant woman or a lactating woman
15. A person who has serious mental disabilities
16. A person who requires the administration of drugs prohibited from concomitant use
17. A person who is administered another investigational drug or has been provided with a clinical trial medical device within 6 months prior to participating in a clinical trial
18. The person whom the investigator determines to be unsuitable for this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GNS-212-E1	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.
Experimental: GNS-212-E2	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.
Active Comparator: GNS-212-ER	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale)	HCS grading of A and B would be classified as successful while C and D would be classified as not successful	on the day of scheduled colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall rate of bowel preparation	Percentage of test subjects for respective HCS grades	On the day of colonoscopy
Overall patient satisfaction and compliance	Subject questionnaire evaluation total volume, taste etc.	before and on the day of colonoscopy

Collaborators and Investigators

• Sponsor: Gunkang Pharmaceuticals, Inc
• Investigators: Principal Investigator: Byeong Gwan Kim, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Actual): October 16, 2024
• Study Completion (Actual): October 16, 2024

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: colonoscopy; Bowel preparation
• Other Study ID Numbers: GNS-212-E; 101772 (Other Identifier: MFDS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No