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

NCT ID: NCT06317350

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-11
• Study Completion Date: 2024-10-16

Brief Summary

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

Conditions

Colonoscopy; Bowel Preparation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GNS-212-E1

Group Type: EXPERIMENTAL

GNS-212-E1

Intervention Type: DRUG

Subjects who are randomized into this group will take GNS-212-E1 from the evening before colonoscopy to the morning of colonoscopy.

GNS-212-E2

Group Type: EXPERIMENTAL

GNS-212-E2

Intervention Type: DRUG

Subjects who are randomized into this group will take GNS-212-E2 from the evening before colonoscopy to the morning of colonoscopy.

GNS-212-ER

Group Type: ACTIVE_COMPARATOR

GNS-212-ER

Intervention Type: DRUG

Subjects who are randomized into this group will take active control drug (PEG3350) from the evening before colonoscopy to the morning of colonoscopy.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gunkang Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Byeong Gwan Kim

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

101772

Identifier Type: OTHER

Identifier Source: secondary_id

GNS-212-E

Identifier Type: -

Identifier Source: org_study_id