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

Last updated: February 17, 2025
Sponsor: Gunkang Pharmaceuticals, Inc
Overall Status: Completed

Phase

3

Condition

Colon Cancer Screening

Treatment

GNS-212-E1

GNS-212-ER

GNS-212-E2

Clinical Study ID

NCT06317350
GNS-212-E
101772
  • Ages 19-79
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult men and women between 19 years and 79 age or older as of the date of consentin 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 acceptablecontraceptive method* during the clinical trial period

*hormonal contraceptive, implantation of intrauterine device or intrauterine system,Infertility procedures/surgery (e.g., bilateral ovarian ligation, vasectomy)

  1. A person who voluntarily agrees to participate in this clinical trial and signs awritten agreement Abbreviation

  2. Women of childbearing potential must have a negative serum or urine pregnancy testbefore Investigational Product administration

Exclusion

Exclusion Criteria:

  1. A person having constipation who is regularly administered laxatives orgastrointestinal motility promoters

  2. A person with a history of significant gastrointestinal surgeries, including colonicresection, subtotal colectomy, abdominoperineal resection

  3. A person diagnosed with acute coronary disease, arrhythmia, cardiomyopathy, cardiacvalvular disease, aortic and peripheral vascular disease

  4. Active infection or high fever above 38°C

  5. Uncontrolled chronic medical illnesses or suspected symptoms that hinderparticipation such as major cardiac, renal, and metabolic (ex, Subjects with severerenal disease).

  6. Clinically significant abnormal laboratory values of screening.(Creatinine, AST orALT )

  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) balloondilatation of the stenosis area (2) non-toxic giant colon or decompression of theS-phase colitis (sigmoid volvulus) (3) Removal of foreign substances (4) Vasculardysplasia, 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 witha clinical trial medical device within 6 months prior to participating in a clinicaltrial

  18. The person whom the investigator determines to be unsuitable for this study

Study Design

Total Participants: 318
Treatment Group(s): 3
Primary Treatment: GNS-212-E1
Phase: 3
Study Start date:
March 11, 2024
Estimated Completion Date:
October 16, 2024

Connect with a study center

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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