ColonoscopyPhase 3GNS-212-ENCT06317350
Clinical Study to Evaluate the Efficacy and Safety of GNS-212-E in Bowel Preparation for Colonoscopy
A Phase 3 study testing GNS-212-E1, GNS-212-E2 and GNS-212-ER in people with Colonoscopy and Bowel Preparation, run by Gunkang Pharmaceuticals, Inc at 4 sites in South Korea.
Trial summary
This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Colonoscopy, Bowel Preparation
- What is being tested?
- GNS-212-E1, GNS-212-E2 and GNS-212-ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 11 Mar 2024to 16 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women between 19 years and 79 age or older as of the date of consent in writing
- 19 kg/㎡ ≤ BMI < 30 kg/㎡
- a prospective colonoscopy patient
- 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)
- A person who voluntarily agrees to participate in this clinical trial and signs a written agreement Abbreviation
- Women of childbearing potential must have a negative serum or urine pregnancy test before Investigational Product administration
Who cannot join
- A person having constipation who is regularly administered laxatives or gastrointestinal motility promoters
- A person with a history of significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection
- A person diagnosed with acute coronary disease, arrhythmia, cardiomyopathy, cardiac valvular disease, aortic and peripheral vascular disease
- Active infection or high fever above 38°C
- Uncontrolled chronic medical illnesses or suspected symptoms that hinder participation such as major cardiac, renal, and metabolic (ex, Subjects with severe renal disease).
- Clinically significant abnormal laboratory values of screening.(Creatinine, AST or ALT )
Show all 18Show fewer
- Active hepatitis B or hepatitis C with positive HBsAg and HCV Ab tests at screening
- Positive for Human Immuno-deficiency Virus (HIV) at the time of screening
- Severe nausea or vomiting
- Severe abdominal distension or abdominal pain
- A person prone to aspiration or reflux
- 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
- A person who is hypersensitive to the ingredients of a clinical trial drug
- Pregnant woman or a lactating woman
- A person who has serious mental disabilities
- A person who requires the administration of drugs prohibited from concomitant use
- 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
- The person whom the investigator determines to be unsuitable for this study
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Seoul National University Bundang Hospital
Gyeonggi-do
Asan Medical Center.
Seoul
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: A Prospective, Randomized, Parallel, Multi-center, Active Controlled, Single Blind (Assessor), Phase 3 Clinical Trial in Bowel Preparation for Colonoscopy
This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial.
- Conditions
- Colonoscopy, Bowel Preparation
- Being tested
- GNS-212-E1, GNS-212-E2, GNS-212-ER
- Keywords
- colonoscopy, Bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNS-212-E1Drug
Subjects who are randomized into this group will take GNS-212-E1 from the evening before colonoscopy to the morning of colonoscopy.
GNS-212-E2Drug
Subjects who are randomized into this group will take GNS-212-E2 from the evening before colonoscopy to the morning of colonoscopy.
GNS-212-ERDrug
Subjects who are randomized into this group will take active control drug (PEG3350) from the evening before colonoscopy to the morning of colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| GNS-212-E1 | Experimental | Not described Receives: Drug: GNS-212-E1 |
| GNS-212-E2 | Experimental | Not described Receives: Drug: GNS-212-E2 |
| GNS-212-ER | Active comparator | Not described Receives: Drug: GNS-212-ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: on the day of scheduled colonoscopy
Secondary outcomes (2)
Overall rate of bowel preparation
Percentage of test subjects for respective HCS grades
Measured: On the day of colonoscopy
Overall patient satisfaction and compliance
Subject questionnaire evaluation total volume, taste etc.
Measured: before and on the day of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start11 Mar 2024
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gunkang Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byeong Gwan Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317350
- Sponsor's protocol ID
- GNS-212-E
- Acronym
- GNS-212-E
- Status last verified
- Nov 2026
- First submitted
- 12 Mar 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Parallel, Multi-center, Active Controlled, Single Blind (Assessor), Phase 3 Clinical Trial in Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT06317350
- Acronym / sponsor ID
- GNS-212-E / GNS-212-E
- Conditions
- Colonoscopy, Bowel Preparation
- Keywords
- colonoscopy, Bowel preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Gunkang Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GNS-212-E1 | Experimental | Drug: GNS-212-E1 |
| GNS-212-E2 | Experimental | Drug: GNS-212-E2 |
| GNS-212-ER | Active comparator | Drug: GNS-212-ER |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult men and women between 19 years and 79 age or older as of the date of consent in writing
- 19 kg/㎡ ≤ BMI < 30 kg/㎡
- a prospective colonoscopy patient
- 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)
Key exclusion criteria (18 listed)
- A person having constipation who is regularly administered laxatives or gastrointestinal motility promoters
- A person with a history of significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection
- A person diagnosed with acute coronary disease, arrhythmia, cardiomyopathy, cardiac valvular disease, aortic and peripheral vascular disease
- Active infection or high fever above 38°C
- Uncontrolled chronic medical illnesses or suspected symptoms that hinder participation such as major cardiac, renal, and metabolic (ex, Subjects with severe renal disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNS-212-E1Subjects who are randomized into this group will take GNS-212-E1 from the evening before colonoscopy to the morning of colonoscopy. | Drug | GNS-212-E1 |
| GNS-212-E2Subjects who are randomized into this group will take GNS-212-E2 from the evening before colonoscopy to the morning of colonoscopy. | Drug | GNS-212-E2 |
| GNS-212-ERSubjects who are randomized into this group will take active control drug (PEG3350) from the evening before colonoscopy to the morning of colonoscopy. | Drug | GNS-212-ER |
Primary outcome
To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale)
Time frame: 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
2 secondary outcomes
Overall rate of bowel preparation
Time frame: On the day of colonoscopy
Overall patient satisfaction and compliance
Time frame: before and on the day of colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byeong Gwan Kim principal investigator
Seoul National University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GNS-212-E1, GNS-212-E2 and GNS-212-ER in people with Colonoscopy and Bowel Preparation, run by Gunkang Pharmaceuticals, Inc at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale) (time frame: on the day of scheduled colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.