Tokyo, July 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062237) titled 'A Randomized Controlled Trial of a New Oral Sulfate Solution for Bowel Preparation' on July 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Keio University

Condition: Condition - Cases who are deemed necessary for a colonoscopy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate whether the administration of a new oral sulphate solution in plastic bottles (NOSS-P) using a split-dose method for bowel preparation (BP) increases the rate of morning colonoscopy (MC: colonoscopy performed in the morning). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Bowel preparation regimen (same-day NOSS-P administration) Interventions/Control_2 - Bowel preparation regimen (split-dose NOSS-P administration)

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 20 or over undergoing MC at Keio University Hospital. Key exclusion criteria - 1. Cases where the patient is unable to attend the clinic by 9.00 am on the day of the MS (as MC cannot be administered) 2. Cases where the patient is unable to correctly understand the method of administration for NOSS-P (as MC cannot be administered) 3. Cases with a history of hypersensitivity to any of the components of this medicinal product 4. Cases where gastrointestinal obstruction or intestinal obstruction is suspected 5. Cases with intestinal perforation 6. Cases with gastric stasis 7. Cases of toxic megacolon 8. Patients with severe renal impairment (creatinine clearance less than 30 mL/min) 9. Any other cases deemed unsuitable for participation in this study by the principal investigator or a co-investigator Target Size - 194

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 02 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071218

Disclaimer: Curated by HT Syndication.