UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052186 |
|---|---|
| Receipt number | R000059557 |
| Scientific Title | Retrospective observational study of Carotegrast methyl investigating efficacy and safety |
| Date of disclosure of the study information | 2023/09/12 |
| Last modified on | 2024/03/25 10:30:20 |
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Basic information
Public title
Retrospective observational study of Carotegrast methyl investigating efficacy and safety
Acronym
Retrospective observational study of Carotegrast methyl investigating efficacy and safety
Scientific Title
Retrospective observational study of Carotegrast methyl investigating efficacy and safety
Scientific Title:Acronym
Retrospective observational study of Carotegrast methyl investigating efficacy and safety
Region
| Japan |
Condition
Condition
Ulcerative colitis (UC) patients treated with Carotegrast methyl from May 2022 to December 2022
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and the safety of Carotegrast methyl under clinical practice by endoscopic evaluation and symptom diary evaluation, and by investigating treatment information after remission.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endoscopic remission rate (Mayo endoscopy score 0, 1 defined as remission)
Key secondary outcomes
- Incidence of side effects
- duration of a drug administration
- Endoscopic Image Evaluation
- Changes in Mayo Scores
- Changes in CAI Scores
- Changes in frequency of defecation, diarrhea, presence of bloody stools, and abdominal pain
- Comparison of background information between cases that achieved remission and those that did not
(cases of remission achieved)
- Use of Remission Maintenance Therapy Medications, Relapse or Not, Time to Relapse, Medications and Their Efficacy at Relapse, and Transition Rate to Advanced Therapy
(Non-achievers in remission)
- Therapy and its efficacy after administration of Carotegrast methyl
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with inadequate response or intolerance to treatment with 5-ASA
2) Patients with moderately active UC (any disease type)
Key exclusion criteria
None
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Toshihide |
| Middle name | |
| Last name | Ohmori |
Organization
Ohmori Toshihide gastro-intestinal Clinic
Division name
director
Zip code
362-0075
Address
1F Kashiwaba Building, 2-8-2 Kashiwaza, Ageo-shi, Saitama, Japan
TEL
048-778-4567
toshihideo@gmail.com
Public contact
Name of contact person
| 1st name | Toshihide |
| Middle name | |
| Last name | Ohmori |
Organization
Ohmori Toshihide gastro-intestinal Clinic
Division name
director
Zip code
362-0075
Address
1F Kashiwaba Building, 2-8-2 Kashiwaza, Ageo-shi, Saitama, Japan
TEL
048-778-4567
Homepage URL
toshihideo@gmail.com
Sponsor or person
Institute
Ohmori Toshihide gastro-intestinal Clinic
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
Ethics Review Committee, Kanazawa-Bunko Hospital, Kyoyukai Medical Corporation
Address
2-6-22 Kamariya-higashi, Kanazawa-ku, Yokohama-shi, Kanagawa
Tel
045-786-3394
h.itou@kanabun-hp.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
| 2023 | Year | 09 | Month | 12 | 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
14
Results
The endoscopic remission rate was 64.3% ( 9 of 14 patients were in remission) , with it's 95% confidence interval ranging 35.1% - 87.2%.
Results date posted
| 2024 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Four patients (28.6%) were males and 10 patients (71.4%) were females.
The mean age was 43.6 years.
The mean BMI was 23.2 kg/m2.
Fourteen patients (100%) were non-smokers.
The duration of UC was less than 12 weeks for 0 patient (0.0%), between 12 weeks and 1 year for 1 patient (7.1%), between 1 year and 5 years for 6 patients (42.9%), and 5 years or more for 7 pstients (50.0%).
The mean Mayo score* was 7.3.
*: Three patients who exceeded 2 weeks from the date of endoscopy to the start of carotegrastomethyl administration were excluded.
Participant flow
Adverse events
No adverse events
Outcome measures
<Primary outcomes>
Endoscopic remission rate (Mayo endoscopy score 0, 1 defined as remission)
<Key secondary outcomes>
･Incidence of side effects
･duration of a drug administration
･Endoscopic Image Evaluation
･Changes in Mayo Scores
･Changes in CAI Scores
･Changes in frequency of defecation, diarrhea, presence of bloody stools, and abdominal pain
･Comparison of background information between cases that achieved remission and those that did not
(In cases of remission achieved)
･Use of Remission Maintenance Therapy Medications, Relapse or Not, Time to Relapse, Medications and Their Efficacy at Relapse, and Transition Rate to Advanced Therapy
(In non-achievers in remission)
･Therapy and its efficacy after administration of Carotegrast methyl
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 09 | Month | 22 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 18 | Day |
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 09 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059557
