mild to moderate ulcerative colitis
Conditions
Interventions
After eligibility is confirmed and written consent is obtained, the study participants will be administered budesonide enteric-coated extended-release tablets for 8 weeks. The dose of budesonide will
Sponsors
Suzuki Yasuo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients for whom written consent was obtained prior to the study by the patient himself or herself 2)Patients older than 18 years at the time of informed consent 3)Active ulcerative colitis patients with a p-Mayo total score between 2 and 7, inclusive, at baseline (Week 0), and a rectal bleeding subscore or a physician's global assessment (PGA) subscore of at least 1 4)Patients who have been treated with the same oral formulation of 5-ASA for at least 4 weeks at the beginning of the observation period (Week 0) 5)Patients who can continue treatment with the dosage and administration before the start of observation period, if they are using the restricted concomitant drugs specified in 5.5.1 at the start of the observation period (Week 0) for at least 4 weeks before the start of the observation period
Exclusion criteria
Exclusion criteria: 1)Patients with contraindications to budesonide enteric-coated extended-release tablets (see package insert) 2)Patients using biological agents, JAK inhibitors, immunosuppressive agents (excluding azathioprine formulations), steroids (excluding budesonide enteric-coated extended-release tablets), budesonide rectal foam, and CAP therapy at the start of the observation period (Week 0) 3)Other patients who are judged by researchers and others as inappropriate for the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rates of symptomatic remission at Final Assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The rates of symptomatic remission at Week 4 and 8 2) The rates of clinical remission at Week 4 and 8/final assessment 3) The rates of clinical improvement at Week 4 and 8/final assessment 4) Change from Week 0 in p-Mayo total score at Week 4 and 8/final assessment 5) Change from Week 0 in rectal bleeding subscore at Week 4 and 8/Final Assessment 6) Change from Week 0 in stool frequency subscore at Week 4 and 8/final assessment 7) Change from Week 0 in abdominal pain score at Week 4 and 8/Final Assessment 8) Change from Week 0 in urgency score from Week 0 at Week 4 and 8/Final Assessment 9) Change from Week 0 in IBDQ at Week 8/Final Assessment 10) Adherence at Week 4 and Week 8/Final Assessment (number of tablets taken during the observation period divided by days taken) 11) Change from Week 0 in Biomarkers (CRPs, LRG, PGEMUM) at Weeks 4 and 8/Final Assessment Incidence of adverse events and adverse drug reactions Multivariate and univariate analyses of background factors and evaluation of predictors of efficacy | — |
Contacts
Public ContactYasuo Suzuki
Ginza Central Clinic
Outcome results
None listed