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

Phase 3

Completed

• Conditions: Colonoscopy; Bowel Preparation
• Interventions: Drug: GNS-212-E1; Drug: GNS-212-E2; Drug: GNS-212-ER

• Registration Number: NCT06317350
• Lead Sponsor: Gunkang Pharmaceuticals, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-11
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-19
• Primary Completion: 2024-10-16
• Study Completion: 2024-10-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GNS-212-E1	GNS-212-E1	-
GNS-212-E2	GNS-212-E2	-
GNS-212-ER	GNS-212-ER	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of