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Efficacy and Safety of DWJ1609 for Bowel Cleansing Before Colonoscopy;

NCT06062030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2024-12-20

No results posted yet for this study

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)

Conditions

  • Colonoscopy

Interventions

DRUG

DWJ1609

Drug of test group

DRUG

DWC202304

Drug of control group

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-08
Primary Completion
2024-06-03
Completion
2024-06-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06062030 on ClinicalTrials.gov