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

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 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

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

Value
https://center6.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