Efficacy and Safety of DWJ1609 for Bowel Cleansing Before Colonoscopy;
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 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)
Timeline
- Start
- 2024-03-08
- Primary completion
- 2024-06-03
- Completion
- 2024-06-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | DWC202304 | Unknown | 14 unknown | — |
| Subject | DWJ1609 | Unknown | 10 unknown | — |
Indications
No indication recorded.