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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044192
Receipt No. 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 2021/05/12

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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
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
Email 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
Email takahiro.nitta@mochida.co.jp

Sponsor
Institute MOCHIDA PHARMACEUTICAL CO., LTD.
Institute
Department

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
Email 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 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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2021 Year 05 Month 31 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.

Management information
Registered date
2021 Year 05 Month 12 Day
Last modified on
2021 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050459

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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