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

NCT06317350 | Completed Phase 3

• 2 other identifiers: GNS-212-E101772
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colonoscopy; Bowel Preparation

Keywords

colonoscopy; Bowel preparation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall rate of bowel preparation

  On the day of colonoscopy

• Overall patient satisfaction and compliance

  before and on the day of colonoscopy

Study Arms (3)

GNS-212-E1

EXPERIMENTAL

Drug: GNS-212-E1

GNS-212-E2

EXPERIMENTAL

Drug: GNS-212-E2

GNS-212-ER

ACTIVE COMPARATOR

Drug: GNS-212-ER

Interventions

GNS-212-E1 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-E1

GNS-212-E2 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-E2

GNS-212-ER DRUG

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

GNS-212-ER

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men and women between 19 years and 79 age or older as of the date of consent in writing
• kg/㎡ ≤ BMI \< 30 kg/㎡
• a prospective colonoscopy patient
• 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)
• A person who voluntarily agrees to participate in this clinical trial and signs a written agreement Abbreviation
• Women of childbearing potential must have a negative serum or urine pregnancy test before Investigational Product administration

You may not qualify if:

• A person having constipation who is regularly administered laxatives or gastrointestinal motility promoters
• A person with a history of significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection
• A person diagnosed with acute coronary disease, arrhythmia, cardiomyopathy, cardiac valvular disease, aortic and peripheral vascular disease
• Active infection or high fever above 38°C
• Uncontrolled chronic medical illnesses or suspected symptoms that hinder participation such as major cardiac, renal, and metabolic (ex, Subjects with severe renal disease).
• Clinically significant abnormal laboratory values of screening.(Creatinine, AST or ALT )
• Active hepatitis B or hepatitis C with positive HBsAg and HCV Ab tests at screening
• Positive for Human Immuno-deficiency Virus (HIV) at the time of screening
• Severe nausea or vomiting
• Severe abdominal distension or abdominal pain
• A person prone to aspiration or reflux
• 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
• A person who is hypersensitive to the ingredients of a clinical trial drug
• Pregnant woman or a lactating woman
• A person who has serious mental disabilities

Sponsors & Collaborators

• Gunkang Pharmaceuticals, Inc: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• Byeong Gwan Kim

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: March 11, 2024
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

KR (1)