A prospective, randomized, parallel, multi-center, active controlled, single blind (Assessor), phase 3 clinical trial in bowel preparation for colonoscopy
NCT ID NCT06317350
First seen Sep 10, 2026 · Last updated Sep 10, 2026
Summary
This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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318 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Oct 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Seoul National University Hospital
Seoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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