Clinical Trial: A Multicenter, Open-Label, Randomized Controlled Trial to Evaluate the Effect of Concomitant Oral Budesonide MMX on Treatment Outcomes in Ulcerative Colitis (Japan)

Tokyo, March 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060928) titled 'A Multicenter, Open-Label, Randomized Controlled Trial to Evaluate the Effect of Concomitant Oral Budesonide MMX on Treatment Outcomes in Ulcerative Colitis' on March 13.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Kobe University

Condition: Condition - ulcerative colitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate whether the addition of oral budesonide MMX to 5-aminosalicylic acid (5-ASA) therapy improves early treatment outcomes in patients with mild-to-moderate ulcerative colitis in an open-label, multicenter study. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 5-ASA monotherapy: maximum dose of 5-ASA for 56 days Interventions/Control_2 - 5-ASA plus oral budesonide MMX 9mg for 56 days in addition to maximum dose of 5-ASA

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1) Diagnosed with UC (including proctitis) 2) No prior UC treatment or currently untreated 3) Mild-to-moderate UC (Mayo score =1) with stool frequency and rectal bleeding subscores both >0 4) Age 18-75 years 5) Written informed consent obtained Key exclusion criteria - 1) Severe hepatic impairment (Child-Pugh C or higher) 2) Severe renal impairment (eGFR <30 mL/min) 3) Pregnant or breastfeeding 4) Use of 5-ASA, steroids, immunomodulators, biologics, JAK inhibitors, or apheresis within 12 weeks 5) History of hypersensitivity to salicylates 6) On desmopressin for nocturia 7) Inability to provide consent, adhere, or record symptoms 8) Deemed ineligible by investigator Target Size - 90

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 04 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069297

Disclaimer: Curated by HT Syndication.