UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042027 |
|---|---|
| Receipt number | R000047963 |
| Scientific Title | Effect of budesonide 2-mg foam on urgency and quality of life in patients with ulcerative colitis. |
| Date of disclosure of the study information | 2020/10/06 |
| Last modified on | 2023/09/27 08:17:11 |
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Basic information
Public title
Effect of budesonide 2-mg foam on urgency and quality of life in patients with ulcerative colitis.
Acronym
QUIET Study
Scientific Title
Effect of budesonide 2-mg foam on urgency and quality of life in patients with ulcerative colitis.
Scientific Title:Acronym
QUIET Study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of budesonide foam on clinical symptoms (bowel urgency, bowel incontinence) and QOL in patients with ulcerative colitis. In addition, to confirm the effectiveness and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of Loss of bowel urgency
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with active ulcerative colitis.
2) "How often during the last 2 weeks have you been troubled because of fear of not finding a washroom?"
Patient who answered Frequency" or "almost every time" or "Total" to question.
3) Patients whose oral 5-ASA dose has not been changed for 2 weeks prior to the start of the observation period.
4) Patients who are judged by physicians to be appropriate to administer budesonide foam twice a day due to ineffective or difficult another enema administration.
5) Patients who can record a diary according to the investigator instructions.
6) Patients who can continue to visit the hospital during the study.
Key exclusion criteria
1) Patients who have received budesonide foam.
2) Patients receiving 5-ASA (suppository, enema) at the beginning of the observation period.
3) Patients who used steroid enema and steroid suppositories within 2 weeks before the start of observation.
4) Patient who changed the dose of immunomodulator within 8 weeks before the start of observation.
5) Patients receiving treatment with the following drugs
a. Oral steroid
b. JAK inhibitor
c. Calcineurin inhibitor
6) Patients treated with apheresis.
7) Patients who have been or have been treated with biologics.
8) Patients with a history of colorectal resection of the rectum and sigmoid colon or patients who are scheduled for surgical treatment of the gastrointestinal tract during the study period.
9) Patients deemed inappropriate by the investigator to conduct this study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Kobayashi |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
5-9-1 Shirokane Minato-ku, Tokyo 108-8642, Japan
TEL
03-5791-6487
kobataku@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsutoshi |
| Middle name | |
| Last name | Inagaki |
Organization
EA Pharma Co., Ltd.
Division name
Department of Medical
Zip code
104-0042
Address
2-1-1, Irifune, Chuo-ku, Tokyo 104-0042 Japan
TEL
03-6280-9814
Homepage URL
katsutoshi_inagaki@eapharma.co.jp
Sponsor or person
Institute
EA Pharma Co., Ltd.
KISSEI PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co., Ltd.
KISSEI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato Institute Hospital, Research Ethics Committee
Address
5-9-1 Shirokane Minato-ku, Tokyo 108-8642, Japan
Tel
03-5791-6354
chiken@insti.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
No.19057
Org. issuing International ID_1
Kitasato Institute Hospital, Research Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学（大阪府）、北里大学北里研究所病院（東京都）、滋賀医科大学（滋賀県）、東京医科歯科大学（東京都）、東邦大学医療センター佐倉病院（千葉県）、奈良県立医科大学（奈良県）、福岡大学筑紫病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 06 | 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
61
Results
Rate of disappearance of urgency (n=61) (%)
50.8 (95%CI 37.7-63.9)
Results date posted
| 2022 | Year | 10 | Month | 13 | Day |
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 | 11 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Positive observational study
Management information
Registered date
| 2020 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047963
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