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

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.