UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057285 |
|---|---|
| Receipt number | R000065439 |
| Scientific Title | Investigation on the efficacy, safety, and prognosis of Carotegrast Methyl in patients with active ulcerative colitis - Multicenter observational study - |
| Date of disclosure of the study information | 2025/03/14 |
| Last modified on | 2026/06/10 10:24:37 |
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Basic information
Public title
Investigation on the efficacy, safety, and prognosis of Carotegrast Methyl in patients with active ulcerative colitis - Multicenter observational study -
Acronym
CANAL study
Scientific Title
Investigation on the efficacy, safety, and prognosis of Carotegrast Methyl in patients with active ulcerative colitis - Multicenter observational study -
Scientific Title:Acronym
CANAL study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical use, efficacy, safety, and prognosis , and to discuss the usefulness, efficacy and prognostic factors in patients with ulcerative colitis treated with Carotegrast Methyl.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement rate of PRO-2 at 8 weeks of administration
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients aged 16 years or older at the time of obtaining consent
2)Patients who meet all of the following conditions 1 to 5 at the time of the first dose of Carotegrast Methyl
1,Patients aged 15 years or older
2,Patients who have not responded to or are intolerant of treatment with 5-ASA*1
3,Patients with moderate-to-severe*1 active UC(regardless of disease type)
4,Patients with Patient-Reported Outcome 2 (PRO2) (PRO2: total of Mayo frequency subscore and Mayo blood in stool subscore) of 2 points or more, and a blood in stool subscore of 1 point or more
5,Patients who have at least one PRO2 data during the treatment period (including the end of treatment) in addition to the first dose of Carotegrast Methyl .
*1 The diagnosis will be determined according to the diagnostic criteria for ulcerative colitis. If there is no record of the diagnosis in the medical record, the EDC will be used as the original data.
Key exclusion criteria
Patients who meet any of the following criteria at the time of the first dose of Carotegrast Methyl will be excluded.
1)Patients who received concomitant therapy with immunomodulators (azathioprine, 6-mercaptopurine), immunosuppressants (tacrolimus, cyclosporine), Janus kinase inhibitors, biological products, or high-dose intravenous corticosteroid therapy during the first administration of Carotegrast Methyl
2)Patients who have used immunosuppressants (tacrolimus, cyclosporine), Janus kinase inhibitors, biological products, or high-dose intravenous corticosteroid therapy within the past year
3)Patients who received the initial dose of Carotegrast Methyl outside the approved dosage and administration of CAROGRA Tablets
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Fumihito |
| Middle name | |
| Last name | Hirai |
Organization
Fukuoka University Faculty of Medicine
Division name
Department of Gastroenterology
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku Fukuoka 814-0180, JAPAN
TEL
092-801-1011
fuhirai@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumihito |
| Middle name | |
| Last name | Hirai |
Organization
Fukuoka University Faculty of Medicine
Division name
Department of Gastroenterology
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku Fukuoka 814-0180, JAPAN
TEL
092-801-1011
Homepage URL
fuhirai@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Fukuoka University
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization National Clinical Research Council Ethics Review Committee
Address
1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo
Tel
03-6868-7022
c-irb_ug@neues.co.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 14 | 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
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter observational study
The period covered by this research will be from May 2022 to the end of December 2024.
Management information
Registered date
| 2025 | Year | 03 | Month | 14 | Day |
Last modified on
| 2026 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065439
