BPG is committed to discovery and dissemination of knowledge
Clinical Trials Study
Copyright ©The Author(s) 2026. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 14, 2026; 32(6): 113880
Published online Feb 14, 2026. doi: 10.3748/wjg.v32.i6.113880
Efficacy and safety of a novel sodium picosulfate oral tablet in a randomized controlled trial for bowel preparation
Su Bum Park, Sang Bum Kang, Geom Seog Seo, Chang Soo Eun, Chang Hwan Choi, Dong-Hoon Yang, Jae Jun Park, Chang Mo Moon, Sung Hoon Jung, Hyung Park, Mi Hee Park, Ho Kyun Yoo, Jiwon Kim, Jung A Heo, Dong Il Park
Su Bum Park, Department of Internal Medicine, Pusan National University School of Medicine and Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan 50612, South Korea
Sang Bum Kang, Department of Internal Medicine, Daejeon St. Mary’s Hospital, The Catholic University of Korea College of Medicine, Daejeon 34943, South Korea
Geom Seog Seo, Department of Internal Medicine, Wonkwang University School of Medicine, Iksan 54538, South Korea
Chang Soo Eun, Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri 11923, South Korea
Chang Hwan Choi, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul 06973, South Korea
Dong-Hoon Yang, Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, South Korea
Jae Jun Park, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, South Korea
Chang Mo Moon, Department of Internal Medicine, College of Medicine, Ewha Womans University, Seoul 07985, South Korea
Sung Hoon Jung, Department of Internal Medicine, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul 02559, South Korea
Hyung Park, Mi Hee Park, Ho Kyun Yoo, Jiwon Kim, Jung A Heo, Clinical Development Center, Daewoong Pharmaceutical Co., Ltd., Seoul 06170, South Korea
Dong Il Park, Department of Internal Medicine and Gastrointestinal Cancer Center, Samsung Kangbuk Hospital, Sungkyunkwan University School of Medicine, Seoul 03181, South Korea
Author contributions: Park SB drafted the original manuscript; Kang SB, Seo GS, and Eun CS supervised the study; Choi CH and Jung SH validated the results; Yang DH, Park JJ, and Moon CM analyzed and interpreted the data; Park H, Park MH, Yoo HK, Kim J, and Heo JA critically reviewed the manuscript; Park DI contributed to the study design; all authors contributed to editing, read, and approved the final version, and agree to be held accountable for all aspects of the work.
Institutional review board statement: This study was reviewed and approved by the Institutional Review Boards of all participating centers involved in this multicenter clinical trial. All procedures were conducted in accordance with the Declaration of Helsinki and applicable institutional ethical guidelines. Institutional Review Board approval numbers for each center are provided in Supplementary Table 1.
Clinical trial registration statement: This study is registered at ClinicalTrials.gov. The registration identification number is NCT06062030.
Informed consent statement: All participants provided informed consent.
Conflict-of-interest statement: Five authors (Hyung Park, Mi Hee Park, Ho Kyun Yoo, Jiwon Kim, Jung A Heo) are employees of Daewoong Pharmaceutical Co., Ltd. All other authors have no conflicts of interest to declare.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: Data are available on reasonable request.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Dong Il Park, MD, PhD, Professor, Department of Internal Medicine and Gastrointestinal Cancer Center, Samsung Kangbuk Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-Ro, Jongno-Gu, Seoul 03181, South Korea. diksmc.park@samsung.com
Received: September 7, 2025
Revised: November 21, 2025
Accepted: December 29, 2025
Published online: February 14, 2026
Processing time: 150 Days and 4.4 Hours
Core Tip

Core Tip: This multicenter randomized trial evaluated DWJ1609, a newly formulated oral sulfate tablet that incorporates sodium picosulfate with reduced sulfate content. DWJ1609 demonstrated non-inferior bowel cleansing efficacy compared with conventional oral sulfate tablets, while requiring fewer tablets and showing improved tolerability. These findings highlight DWJ1609 as a clinically meaningful alternative that may enhance patient acceptance and optimize colonoscopy preparation. This study provides evidence supporting its effectiveness and safety in routine practice, while noting the need for future research in older adults and patients with comorbidities.