UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044192 |
|---|---|
| Receipt number | R000050459 |
| Scientific Title | The actual condition of combined use of topical preparations in oral 5-ASA preparation treatment for ulcerative colitis. |
| Date of disclosure of the study information | 2021/05/12 |
| Last modified on | 2022/07/05 09:25:00 |
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Basic information
Public title
The actual condition of combined use of topical preparations in oral 5-ASA preparation treatment for ulcerative colitis.
Acronym
The actual condition of combined use of topical preparations in oral 5-ASA preparation treatment for ulcerative colitis.
Scientific Title
The actual condition of combined use of topical preparations in oral 5-ASA preparation treatment for ulcerative colitis.
Scientific Title:Acronym
The actual condition of combined use of topical preparations in oral 5-ASA preparation treatment for ulcerative colitis.
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the actual condition of combined use of topical preparations in oral 5-ASA preparation treatment for ulcerative colitis using health insurance claims database.
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Combination rate
2.Period until the start of combined use
3.Combination duration
4.Combination continuation rate
5.Combination rate transition
6.Oral 5-ASA continuation proportion
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.Datebase registration within the database period.
2. Prescription of oral 5-ASA preparation or topical preparation of 5-ASA or steroid (topical preparation) with diagnosis of ulcerative colitis within the database period.
3. Prescriptions of oral 5-ASA or topical preparations with the earliest diagnosis of ulcerative colitis (Index date) are within the enrollment period.
4. Possible to observe for 6 months from the month before the index date.
5. Possible to observe for the next 13 months including the index date.
6. No treatment for ulcerative colitis for 6 months from the month before the index date.
7. No treatment for ulcerative colitis other than oral 5-ASA or topical preparations in the next 13 months, including Index date.
8. The age at the time of Index date is 16 years or older.
Key exclusion criteria
1. The following diagnostic or implementation records for 6 months from the previous month of the Index and for the next 13 months including the Index.
-Crohn's disease
-Colorectal cancer
-Total and subtotal resection of the colorectal and colon
2. Oral 5-ASA prescriptions outside the approved dose range for the next 13 months, including Index date.
3. Records of unknown prescription dates for oral 5-ASA and topical preparations in the next 13 months, including the Index date.
4. Prescription with unknown drug name or standards for oral 5-ASA and topical preparations in the next 13 months, including the Index date.
Target sample size
2200
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Shimizu |
Organization
MOCHIDA PHARMACEUTICAL CO., LTD.
Division name
MEDICAL AFFAIRS
Zip code
160-0004
Address
1-22 YOTSUYA, SHINJUKU-KU, TOKYO
TEL
03-3225-5138
shimizuy@mochida.co.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Nitta |
Organization
MOCHIDA PHARMACEUTICAL CO., LTD.
Division name
MEDICAL AFFAIRS
Zip code
160-0004
Address
1-22 YOTSUYA, SHINJUKU-KU, TOKYO
TEL
03-3225-5138
Homepage URL
takahiro.nitta@mochida.co.jp
Sponsor or person
Institute
MOCHIDA PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
MOCHIDA 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
N/A
Address
N/A
Tel
N/A
N/A
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
| 2021 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0289-8020/43050/429
Number of participants that the trial has enrolled
2247
Results
The combination proportion of oral therapy with 5-ASA (OT5ASA) and topical therapy (TT) were 21.5 and 21.6% in cohorts 1 (OT5ASA only at the first prescribing) and 2 (TT only), respectively, with no differences between cohorts and medicines. For the proportion of subjects, which prescribing initiation was OT5ASA, with <25% of TT combinations, proportion of time-dependent, pH-dependent and MMX was 28.4, 28.1 and 42.9%, respectively, and OT5ASA continuation proportion were 46.9, 44.9 and 65.9%, respectively.
Results date posted
| 2022 | Year | 07 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 05 | Month | 31 | Day |
Baseline Characteristics
Among the 2,247 patients enrolled, 1,399 were male, and the mean age was 41.2 years.
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study using anonymized data and IRB approval is not required. As the date of IRB, the protocol fixation date was entered as a tentative date.
Management information
Registered date
| 2021 | Year | 05 | Month | 12 | Day |
Last modified on
| 2022 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050459
