Efficacy & Safety of DWJ1609 for Bowel Cleansing Before Colonoscopy;

Status Not yet recruiting

Clinical Trial 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)

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Colonoscopy

Clinical Trial Details

NCT number	NCT06062030
Study type	Interventional
Source	Daewoong Pharmaceutical Co. LTD.
Contact	SEUNGEUN LEE
Phone	+82 1067696368
Email	2230389@daewoong.co.kr
Status	Not yet recruiting
Phase	Phase 3
Start date	November 2023
Completion date	October 2024

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy and Safety of DWJ1609 for Bowel Cleansing Before Colonoscopy;

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms