NCT06062030

Efficacy and Safety of DWJ1609 for Bowel Cleansing Before Colonoscopy;

Efficacy and Safety of DWJ1609 for Bowel Cleansing Before Colonoscopy; a Prospective, Randomized, Single-blinded (Investigator), Parallel, Multi-center, Active-control, Non-inferiority, Phase 3 Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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)

Detailed description

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

Conditions

• Colonoscopy

Interventions

Type	Name	Description
DRUG	DWJ1609	Drug of test group
DRUG	DWC202304	Drug of control group

Timeline

• Start date: 2024-03-08
• Primary completion: 2024-06-03
• Completion: 2024-06-28
• First posted: 2023-10-02
• Last updated: 2024-12-20

Locations

1 site across 1 country: South Korea