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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008563
Receipt No. R000009955
Scientific Title Observational Study on Clinical Practice in the Management of Ulcerative Colitis with Oral 5-Aminosalicylic Acid in Japan
Date of disclosure of the study information 2012/07/30
Last modified on 2016/06/02

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Basic information
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
Condition ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

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
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&reg; tablets 250 mg, Pentasa&reg; tablets 500 mg, Asacol&reg; tablets 400 mg and Salazopyrin&reg; 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

Research contact person
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

Public contact
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

Sponsor
Institute Kyorin Pharmaceutical Co.,Ltd
Institute
Department

Funding Source
Organization Kyorin Pharmaceutical Co.,Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
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
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)

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 30 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 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
Other related information cohort study

Management information
Registered date
2012 Year 07 Month 30 Day
Last modified on
2016 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009955

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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