UMIN-CTR Clinical Trial

Basic information
Public title	Clinical efficacy of budesonide foam in patients with ulcerative colitis taking the maximum dose of oral mesalazine -retrospective observational study-
Acronym	Clinical efficacy of budesonide foam in patients with ulcerative colitis taking the maximum dose of oral mesalazine -retrospective observational study-
Scientific Title	Clinical efficacy of budesonide foam in patients with ulcerative colitis taking the maximum dose of oral mesalazine -retrospective observational study-
Scientific Title:Acronym	Clinical efficacy of budesonide foam in patients with ulcerative colitis taking the maximum dose of oral mesalazine -retrospective observational study-
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the efficacy of budesonide foam as a treatment option for ulcerative colitis with poor response to the maximum dose of oral mesalazine.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Difference in Mayo endoscopic subscore (MES) between pre-treatment and post-treatment evaluation (patients treated with budesonide foam for at least 6 weeks)
Key secondary outcomes	Difference in Mayo score between pre-treatment and post-treatment evaluation (patients treated with budesonide foam for at least 6 weeks)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Males and females aged at least 16 years at pre-treatment. 2)Patients diagnosed with mild to moderate ulcerative colitis. 3)Patients with rectosigmoid inflammation detected by colonoscopy or anoscopy within one month before treatment. 4)Patients treated with twice daily budesonide foam during the study period. 5)Patients prescribed with the maximum dose of daily mesalazine formulation from at least 4 weeks before the beginning of budesonide foam treatment to the end of the treatment. (Asacol tablets 3.6g, Pentasa tablets 4.0g, Pentasa granules 4.0g, Salazosulfapyridine tablets 4.0g, Lialda tablets 4.8g) 6)Patients who underwent colonoscopy for response evaluation within 2 months after the end of budesonide foam treatment.
Key exclusion criteria	Patients who changed dosage and administration of formulations including steroids and thiopurines during the treatment period.
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toshihide Ohmori
Organization	Ohmori Toshihide gastro-Intestinal Clinic
Division name	Director
Zip code
Address	Kashiwaba Building 1th Floor 2-8-2 Kashiwaza, Ageo, Saitama, Japan
TEL	048-778-4567
Email	info@ohmori-toshihide-clinic.com

Public contact
Name of contact person	1st name Middle name Last name Toshihide Ohmori
Organization	Ohmori Toshihide gastro-Intestinal Clinic
Division name	Director
Zip code
Address	Kashiwaba Building 1th Floor 2-8-2 Kashiwaza, Ageo, Saitama, Japan
TEL	048-778-4567
Homepage URL
Email	info@ohmori-toshihide-clinic.com

Sponsor
Institute	Ohmori Toshihide gastro-Intestinal Clinic
Institute
Department

Funding Source
Organization	EA Pharma Co., LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	大森敏秀胃腸科クリニック

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 05 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	Completed
Date of protocol fixation	2019 Year 02 Month 01 Day
Date of IRB	2019 Year 02 Month 19 Day
Anticipated trial start date	2019 Year 03 Month 01 Day
Last follow-up date	2019 Year 03 Month 08 Day
Date of closure to data entry	2019 Year 03 Month 08 Day
Date trial data considered complete	2019 Year 03 Month 15 Day
Date analysis concluded	2019 Year 04 Month 30 Day

Other
Other related information	Difference in Mayo endoscopic subscore (MES)between pre-treatment and post-treatment evaluation (patients treated with budesonide foam for at least 6 weeks)

Management information
Registered date	2019 Year 03 Month 04 Day
Last modified on	2019 Year 06 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041104