CompletedPhase 3

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

South Korea318 participantsStarted 2024-03-11

Plain-language summary

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

Age range19 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult men and women between 19 years and 79 age or older as of the date of consent in writing
✓. 19 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
✓. 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

✕. 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

To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale)

Timeframe: on the day of scheduled colonoscopy

NCT IDNCT06317350

SponsorGunkang Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-16

Who can participate

Age range19 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult men and women between 19 years and 79 age or older as of the date of consent in writing
✓. 19 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
✓. 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

✕. 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