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

2026-02-14
World journal of gastroenterology 32(6)
- 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

PubMed: 41695285
DOI: 10.3748/wjg.v32.i6.113880

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 215
Population: 215 participants
Methods: prospective, randomized, single-blinded (investigator), multicenter, phase III clinical trial
Blinding: Single-blind
Funding: Unclear

Large Human Trial

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.