UMIN-CTR Clinical Trial

Public title

Observational Study on Clinical Practice in the Management of
Ulcerative Colitis with Oral 5-Aminosalicylic Acid in Japan

Acronym

OPTIMUM Study

Scientific Title

Observational Study on Clinical Practice in the Management of
Ulcerative Colitis with Oral 5-Aminosalicylic Acid in Japan

Scientific Title:Acronym

OPTIMUM Study

Region

Japan

Condition

ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objectives of this study are to investigate how oral 5-ASA drugs have been used in the remission stage, or in the active stage to the remission stage in ulcerative colitis and to study cumulative non-relapse rate, number of relapses, disease activity, according to the administration method including medication adherence

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Cumulative non-relapse rate

Key secondary outcomes

1)Number of relapses
2)Duration of remission maintained (days)
3)The pUCDAI scores and the scores that constitute these pUCDAI scores at each assessment period
4)Medication adherence

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Outpatients
2) Adult patients who have been diagnosed with mild to moderate active ulcerative colitis or ulcerative colitis in the remission stage according to the diagnostic criteria for ulcerative colitis (draft revised on February 13, 2010)
3) Patients who have been treated with remission induction therapy or remission maintenance therapy with oral 5-ASA drugs (Pentasa® tablets 250 mg, Pentasa® tablets 500 mg, Asacol® tablets 400 mg and Salazopyrin® tablets 500 mg as well as drugs that have been proved equivalent to these drugs)
4) Patients who have received adequate information regarding this study and understood thoroughly, and then voluntarily submitted written consent forms upon participation in this study

Key exclusion criteria

1) Patients with severe active ulcerative / fulminant ulcerative colitis according to the diagnostic criteria for ulcerative colitis (draft revised on February 13, 2012)
2) Patients who have received total / subtotal colectomy
3) Patients who have been complicated with malignant tumor
4) Patients who are pregnant or possibly pregnant
5) Other patients whom investigators and subinvestigators considered inappropriate to participate in this study

Target sample size

5000

Name of lead principal investigator

1st name
Middle name
Last name	Soji Omuro

Organization

Kyorin Pharmaceutical Co.,Ltd

Division name

Medical Affairs

Zip code

Address

6, Kanda Surugadai 4-chome, Chiyoda-ku, Tokyo

TEL

03-3525-4787

Email

souji.oomuro@mb.kyorin-pharm.co.jp

Name of contact person

1st name
Middle name
Last name	Michiaki Ota

Organization

Kyorin Pharmaceutical Co.,Ltd

Division name

Medical Affairs

Zip code

Address

6, Kanda Surugadai 4-chome, Chiyoda-ku, Tokyo

TEL

03-3525-4787

Homepage URL

Email

michiaki.oota@mb.kyorin-pharm.co.jp

Institute

Kyorin Pharmaceutical Co.,Ltd

Institute

Department

Personal name

Organization

Kyorin Pharmaceutical Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

NCT01654783

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学病院（東京都）、東京医科歯科大学医学部附属病院（東京都）、吉成台内科胃腸科（宮城県）、高木外科内科胃腸科医院（宮城県）、野口胃腸内科（宮城県）、アルト新橋胃腸肛門クリニック（東京都）、亀高医院（東京都）、品川シーサイド肛門科胃腸科クリニック（東京都）、豊島園大腸肛門科（東京都）、池袋藤久ビルクリニック（東京都）、井の頭通り　こう門科胃腸科（東京都）、平塚胃腸病院（東京都）

Date of disclosure of the study information

2012

Year

07

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

07

Month

09

Day

Date of IRB

Anticipated trial start date

2012

Year

09

Month

04

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

cohort study

Registered date

2012

Year

07

Month

30

Day

Last modified on

2016

Year

06

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009955