Efficacy and safety of a novel sodium picosulfate oral tablet in a randomized controlled trial for bowel preparation

doi:10.3748/wjg.v32.i6.113880

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Feb 14, 2026 (publication date) through Feb 2, 2026

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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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 Hours

Abstract

BACKGROUND

Oral sulfate tablets (OSTs) are commonly used in South Korea, but the requirement to ingest 28 tablets and concerns regarding renal and gastrointestinal safety may reduce patient compliance. DWJ1609 is a novel OST formulation that contains sodium picosulfate and 25% less sulfate, requiring only 20 tablets. This modification is expected to improve tolerability while maintaining cleansing efficacy.

AIM

To evaluate the bowel cleansing efficacy and safety of DWJ1609 compared with conventional OSTs and to assess adverse events.

METHODS

This prospective, randomized, single-blinded (investigator), multicenter, phase III clinical trial was conducted at seven university hospitals in South Korea. The primary endpoint was the non-inferiority of DWJ1609 based on the proportion of participants achieving a “successful” grade A or B on the Harefield Cleansing Scale, as assessed by independent central readers. Safety was monitored through adverse events and laboratory evaluations.

RESULTS

Overall, 215 participants were randomized, and 200 were included in the per-protocol analysis (DWJ1609: 99; OST: 101). Successful bowel cleansing was achieved in 96.97% of the DWJ1609 group, which was non-inferior to the OST group (100.00%), with a difference of 3.03%. DWJ1609 showed significantly higher tolerability, with lower incidence of nausea, headache, and dizziness, although vomiting occurred slightly more frequently.

CONCLUSION

DWJ1609 demonstrated non-inferior bowel cleansing efficacy, improved tolerability, and a favorable safety profile compared with conventional. DWJ1609 has the potential to improve compliance and overall quality of colonoscopy.

Keywords: DWJ1609; Sodium picosulfate; Oral sulfate tablets; Bowel preparation; Colon cleansing

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.