ulcerative colitis
Conditions
Interventions
5-ASA monotherapy: maximum dose of 5-ASA for 56 days
5-ASA plus oral budesonide MMX 9mg for 56 days in addition to maximum dose of 5-ASA
Sponsors
Kobe University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed with UC (including proctitis) 2) No prior UC treatment or currently untreated 3) Mild-to-moderate UC (Mayo score <=10, MES >=1) with stool frequency and rectal bleeding subscores both >0 4) Age 18-75 years 5) Written informed consent obtained
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the SCCAI (Simple Clinical Colitis Activity Index) at Day 28 after treatment initiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| PRO2 (Patient-Reported Outcome-2) score through Day 28 after treatment initiation. SCCAI (Simple Clinical Colitis Activity Index) on Day 0 (treatment initiation), and on Days 14, 28, and 56 after treatment initiation. Partial Mayo score on Day 0 (treatment initiation), and on Days 14, 28, and 56 after treatment initiation. | — |
Countries
Japan
Contacts
Public ContactYuichiro Aoyama
Kobe University Graduate School of Medicine Department of Internal Medicine, Division of Gastroenterology
Outcome results
None listed