UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050459