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CompletedNCT06317350GNS-212-EUpdated Sep 10, 2026

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

A Phase 3 interventional study of GNS-212-E1 and GNS-212-E2 in Colonoscopy and Bowel Preparation, sponsored by Gunkang Pharmaceuticals, Inc. Completed at 1 site in South Korea. Open to participants aged 19 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Gunkang Pharmaceuticals, Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
318
Allocation
Randomized
Ages
19 Years to 79 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Colonoscopy
  • Bowel Preparation

Keywords

  • colonoscopy
  • Bowel preparation
03

In context

Lead sponsor

This is the only study on the registry with Gunkang Pharmaceuticals, Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 79 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
318 participants (actual)

Study arms

  • Experimental
    GNS-212-E1

    Drug: GNS-212-E1

  • Experimental
    GNS-212-E2

    Drug: GNS-212-E2

  • Active comparator
    GNS-212-ER

    Drug: GNS-212-ER

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.

06

What researchers measure

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

    Time frame: on the day of scheduled colonoscopy

Secondary outcomes

  1. Overall rate of bowel preparation

    Percentage of test subjects for respective HCS grades

    Time frame: On the day of colonoscopy

  2. Overall patient satisfaction and compliance

    Subject questionnaire evaluation total volume, taste etc.

    Time frame: before and on the day of colonoscopy

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06317350
Lead sponsor
Gunkang Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Mar 19, 2024
Start date
Mar 11, 2024
Primary completion
Oct 16, 2024
Completion
Oct 16, 2024
Last update
Sep 10, 2026

Study contacts

Byeong Gwan Kim
principal investigator · Seoul National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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