Efficacy and Safety of DWJ1609 for Bowel Cleansing Before Colonoscopy;
Status:
Not yet recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
Summary
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 5 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)