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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036077
Receipt No. R000041104
Scientific Title Clinical efficacy of budesonide foam in patients with ulcerative colitis taking the maximum dose of oral mesalazine -retrospective observational study-
Date of disclosure of the study information 2019/03/05
Last modified on 2019/06/17

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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