Phase of Development : III Sponsor : DAEWOONG PHARMACEUTICAL Study Sites and Principal Investigator : Dong ll Park M.D. Ph.D , Gastroenterology Kangbuk Samsung Hospital and other 6 study sites Study Period : From the protocol approval date (institutional review board, IRB) 24 Months Investigational product : Investigational Products DWJ1609 (sodium sulfate potassium sulfate, Magnesium Sulfate Anhydrous , simethicone, sodium picosulphate) Control Products DWC202304 (sodium sulfate potassium sulfate, Magnesium Sulfate Anhydrous , simethicone) Target Diseases : A person who needs treatment before colonoscopy (X-ray, endoscopy) Number of Subjects : 214 Subjects in total (85 subjects per group, 2 groups in total, considering a 20% dropout rate)
Study Methodology : Test subjects evaluated as suitable for participation in clinical trials are randomly assigned at a 1:1 ratio to the test group (DWJ1609) and the control group (DWC202304), and clinical trial drugs are distributed for each administration group. Subjects take the distributed clinical trial drugs as split-dose in the early evening of the day before colonoscopy (Day 1) and in the morning of the day of examination (Day 2) Test subjects visit the clinical trial institution after completing all clinical trial drugs at least 2 hours before colonoscopy (Visit 2). All test subjects undergo colonoscopy in the morning, and the tester takes an image of all colonoscopy processes according to a separate manual. For safety evaluation, subjects will conduct a phone visit 2 days after colonoscopy (±1 day) (Visit 3) and a regular visit 7 days after (±1 day) (Visit 4). If additional confirmation is required in the electrocardiogram or laboratory test results at the discretion of the tester, a follow-up visit can be conducted after 28 days (±2 days) (Visit 5). I
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
215
Kangbuk Samsung Hospital
Seoul, Korea, South Korea
The successful cleaning rate of the Harefield Cleansing Scale (HCS) phase rated as 'success'
Evaluate the overall cleanliness in four steps according to the results of each of the five colon sections Grade A: 3 or 4 points for all colon sections Grade B: One or more sections with a score of 2 Grade C: One or more sections with a score of 1 Grade D: One or more sections with a score of 0 ※ If the overall colon cleanliness evaluation result is A grade, it is evaluated as successful 'failure (sealing success)' and C grade or D 'failure (sealing failure).
Time frame: from the beginning to the end of colonoscopy (Baseline)
Percentage of test subjects whose HCS cleanliness was evaluated as 'success'
Evaluate the overall cleanliness in four steps according to the results of each of the five colon sections. Grade A: 3 or 4 points for all colon sections Grade B: One or more sections with a score of 2 Grade C: One or more sections with a score of 1 Grade D: One or more sections with a score of 0 ※ If the overall colon cleanliness evaluation result is A grade, it is evaluated as successful 'failure (sealing success)' and C grade or D 'failure (sealing failure).
Time frame: from the beginning to the end of colonoscopy(Baseline)
Overall cleanliness ratio on HCS (overall cleansing rate)
Percentage of test subjects rated as grade A, B, C, and D on the HCS
Time frame: from the beginning to the end of colonoscopy(Baseline)
Average score for each 5 compartments on the HCS (mean HCS score)
Assessment of crystallinity by five colon sections (rector, sigmoid colon, descending colon, lateral colon, ascending colon)
Time frame: from the beginning to the end of colonoscopy(Baseline)
Percentage of test subjects with residual air bubbles on the bubble score
Assess the degree of gas removal (bubble degree) by five colon sections (rector, sigmoid colon, descending colon, lateral colon, ascending colon) Grade 0 No or minimal scattered bubbbles Grade 1 Bubbles covering at least half the luminal diameter Grade 2 Bubbles covering the circumference of the lumen Grade 3 Bubbles filling the entire lumen
Time frame: from the beginning to the end of colonoscopy(Baseline)
Percentage of test subjects found to have polyps or adenoma (detection of polyp or adenoma)
The examiner checks whether polyps or adenomas are found through colonoscopy, and the test subjects with one or more polyps/adenomas are defined as "detection."
Time frame: from the beginning to the end of colonoscopy(Baseline)
Percentage of test subjects whose endoscopy has reached the appendix (cecal intubation rate)
The cecal intubation is defined as passing the tip of a colonoscopy to the proximal part of the ileocecal valve so that the entire cecal caput is visible, including the inner wall of the cecal valve between the ileocecal valve and the cecal entrance
Time frame: from the beginning to the end of colonoscopy(Baseline)
Total colonoscopy time
The total colonoscopy time is the sum of colonoscopy insertion time and recovery time
Time frame: from the beginning to the end of colonoscopy(Baseline)
Percentage of test subjects in taste category
Subsequently, the intention to use the same colon cleaner during colonoscopy is evaluated as "yes" and "no."
Time frame: End of colonoscopy(Baseline)
Percentage of subjects tested by compliance with administration of clinical trial drugs
1. Percentage of test subjects administered 100% 2. Percentage of test subjects administered 75% or more and less than 100% 3. Percentage of test subjects administered less than 75%
Time frame: End of colonoscopy(Baseline)
IP medication satisfaction
(1) Average score of difficulty when taken
Time frame: from the beginning to the end of colonoscopy(Baseline)
IP medication satisfaction
(2) Percentage of test subjects in category of difficulty in taking
Time frame: from the beginning to the end of colonoscopy(Baseline)
IP medication satisfaction
(3) an average score of taste
Time frame: from the beginning to the end of colonoscopy(Baseline)
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