Bowel Preparation, Colonoscopy
Conditions
Keywords
colonoscopy, Bowel preparation
Brief summary
This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial.
Interventions
DRUGGNS-212-E1
Subjects who are randomized into this group will take GNS-212-E1 from the evening before colonoscopy to the morning of colonoscopy.
DRUGGNS-212-E2
Subjects who are randomized into this group will take GNS-212-E2 from the evening before colonoscopy to the morning of colonoscopy.
DRUGGNS-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.
Sponsors
Gunkang Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall rate of bowel preparation | On the day of colonoscopy | Percentage of test subjects for respective HCS grades |
| Overall patient satisfaction and compliance | before and on the day of colonoscopy | Subject questionnaire evaluation total volume, taste etc. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORByeong Gwan Kim
Seoul National University Hospital
Outcome results
None listed