UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060928 |
|---|---|
| Receipt number | R000069297 |
| Scientific Title | A Multicenter, Open-Label, Randomized Controlled Trial to Evaluate the Effect of Concomitant Oral Budesonide MMX on Treatment Outcomes in Ulcerative Colitis |
| Date of disclosure of the study information | 2026/03/13 |
| Last modified on | 2026/03/13 16:32:58 |
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Basic information
Public title
A Multicenter, Open-Label, Randomized Controlled Trial to Evaluate the Effect of Concomitant Oral Budesonide MMX on Treatment Outcomes in Ulcerative Colitis
Acronym
BUDMMXStudy
Scientific Title
A Multicenter, Open-Label, Randomized Controlled Trial to Evaluate the Effect of Concomitant Oral Budesonide MMX on Treatment Outcomes in Ulcerative Colitis
Scientific Title:Acronym
BUDMMXStudy
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline in the SCCAI (Simple Clinical Colitis Activity Index) at Day 28 after treatment initiation.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | 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 <=10, MES >=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 sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Watanabe |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Internal Medicine, Division of Gastroenterology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6305
daisuke@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Aoyama |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Internal Medicine, Division of Gastroenterology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6305
Homepage URL
yaoyama@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kobe University Graduate School of Medicine and Kobe University Hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
078-382-6669
chiken@med.kobe-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
神戸大学医学部附属病院（兵庫県）、明石医療センター（兵庫県）、兵庫県立加古川医療センター（兵庫県）、北播磨総合医療センター（兵庫県）、甲南医療センター（兵庫県）、神戸赤十字病院（兵庫県）、三田市民病院（兵庫県）、兵庫県立はりま姫路総合医療センター（兵庫県）、高槻病院（大阪府）、淀川キリスト教病院（大阪府）、あんどう消化器内科IBDクリニック（兵庫県）、加古川中央市民病院（兵庫県）、日本生命病院（大阪府）、わき消化器内科IBDクリニック（兵庫県）、青山内科クリニック（兵庫県）、田中内科クリニック（兵庫県）、神戸消化器・内視鏡クリニック（兵庫県）、池田クリニック（兵庫県）、明石山田歯科内科クリニック（兵庫県）、ささき内科クリニック（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 13 | Day |
Last modified on
| 2026 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069297
