UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036077 |
|---|---|
| Receipt number | 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 11:58:49 |
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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
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
info@ohmori-toshihide-clinic.com
Sponsor or person
Institute
Ohmori Toshihide gastro-Intestinal Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041104
