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

Colonoscopy Clinical Trial

— GNS-212-E  

Official title:

A Prospective, Randomized, Parallel, Multi-center, Active Controlled, Single Blind (Assessor), Phase 3 Clinical Trial in Bowel Preparation for Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06317350
• Other study ID #: GNS-212-E
• Secondary ID: 101772
• Status: Recruiting
• Phase: Phase 3
• Start date: March 11, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Gunkang Pharmaceuticals, Inc
• Contact: Hosup Song
• Phone: +82-2-1588-1380
• Email: contact[@]gkpharm.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 318
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gunkang Pharmaceuticals, Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall rate of bowel preparation	Percentage of test subjects for respective HCS grades	On the day of colonoscopy
Secondary	Overall patient satisfaction and compliance	Subject questionnaire evaluation total volume, taste etc.	before and on the day of colonoscopy