UMIN-CTR Clinical Trial

Basic information
Public title	Persistence of oral 5-ASA treatment in ulcerative colitis.
Acronym	Persistence of oral 5-ASA treatment in ulcerative colitis.
Scientific Title	Persistence of oral 5-ASA treatment in ulcerative colitis.
Scientific Title:Acronym	Persistence of oral 5-ASA treatment in 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 persistence of oral 5-ASA treatment in ulcerative colitis using health insurance claims database.
Basic objectives2	Others
Basic objectives -Others	Observational Study
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Persistence of oral 5-ASA treatment
Key secondary outcomes	1. Medication possession ratio of topical preparation 2. Adherence 3. Factors having an impact on persistence 4. Factors having an impact on adherence

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. Database registration within the database period. 2. Prescription of oral 5-ASA preparation with diagnosis of ulcerative colitis within the database period. 3. Prescriptions of oral 5-ASA preparation 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 preparation or topical preparation of 5-ASA or steroid (topical preparation) 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 or topical preparations in the next 13 months, including the Index date.
Target sample size	4400

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Takebe
Organization	MOCHIDA PHARMACEUTICAL CO., LTD.
Division name	MEDICAL AFFAIRS
Zip code	1608515
Address	1-7 YOTSUYA, SHINJUKU-KU, TOKYO 160-8515 JAPAN
TEL	0332255138
Email	takahiro.takebe@mochida.co.jp

Public contact
Name of contact person	1st name Takumi Middle name Last name Ota
Organization	MOCHIDA PHARMACEUTICAL CO., LTD.
Division name	MEDICAL AFFAIRS
Zip code	1608515
Address	1-7 YOTSUYA, SHINJUKU-KU, TOKYO 160-8515 JAPAN
TEL	0332255138
Homepage URL
Email	takumi.ota@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	2022 Year 07 Month 08 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	2022 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 01 Day
Last follow-up date	2022 Year 11 Month 30 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	2022 Year 07 Month 08 Day
Last modified on	2022 Year 07 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055069