Clinical trial NCT06317350: Clinical Study to Evaluate the Efficacy and Safety of GNS-212-E in Bowel Preparation for Colonoscopy
Official title: A Prospective, Randomized, Parallel, Multi-center, Active Controlled, Single Blind (Assessor), Phase 3 Clinical Trial in Bowel Preparation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Bowel Preparation
Keywords: colonoscopy
Bowel preparation
Lead sponsor: Gunkang Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2024-03-19
Enrollment: 318
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale)
timeFrame: on the day of scheduled colonoscopy
Secondary outcomes:
measure: Overall rate of bowel preparation
timeFrame: On the day of colonoscopy
measure: Overall patient satisfaction and compliance
timeFrame: before and on the day of colonoscopy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Byeong Gwan Kim
role: PRINCIPAL_INVESTIGATOR
References: