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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027750
Receipt No. R000031795
Scientific Title An Observational Study of Disease Severity and Quality of Life in Japanese Patients with Ulcerative Colitis
Date of disclosure of the study information 2017/06/30
Last modified on 2017/06/14

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Basic information
Public title An Observational Study of Disease Severity and Quality of Life in Japanese Patients with Ulcerative Colitis
Acronym An Observational Study of Disease Severity and Quality of Life in Japanese Patients with Ulcerative Colitis
Scientific Title An Observational Study of Disease Severity and Quality of Life in Japanese Patients with Ulcerative Colitis
Scientific Title:Acronym An Observational Study of Disease Severity and Quality of Life in Japanese Patients with Ulcerative Colitis
Region
Japan

Condition
Condition Ulcerative Colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate partial Mayo scoring index (assessment) for disease severity; IBDQ, an ulcerative colitis specific QoL measure; and EQ-5D, an overall health QoL indicator in Japanese patients with ulcerative colitis.
Basic objectives2 Others
Basic objectives -Others Assess the relation between disease severity and work productivity/activity impairment (WPAI).

Assess the relation between disease severity and health related QoL (SF-36).

Assess the relation between IBDQ, EQ-5D or SF-36.

Assess disease severity and healthcare resource utilization.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Observational evaluation by research investigator or researcher
-Partial Mayo score

Patient reported Outcomes
-IBDQ (QoL questionaire for IBD)
-EQ-5D (European Quality of Life -5 Dimensions Questionnaire)
-WPAI (Work productivity activity impairment questionaire)
-SF36 (Health related QoL questionaire)

Healthcare resource utilization
Key secondary outcomes Assess the relation between disease severity and work productivity/activity impairment (WPAI).

Assess the relation between disease severity and health related QoL (SF-36).

Assess the relation between IBDQ, EQ-5D or SF-36.

Assess disease severity and healthcare resource utilization.

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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria
1. Individuals between the ages of 18 and 80 upon time of informed consent obtained.
2. Individuals diagnosed with either pan-colitis or left colitis subtype, within the ulcerative colitis diagnostic definition of 2015 revision provided by the Intractable inflammatory intestinal tract disease working group by the Japanese Ministry of Health, Labor and Welfare by the time of informed consent obtained.
3. Individuals with at least three months of medical records available prior to informed consent obtained.
4. Individuals able to sign and date the consensus and explanation forms prior to the research operation.
5. Individuals able to read and understand patient questionnaires.
Key exclusion criteria
1. Individuals determined by the research supervisor or researcher to have potential comorbid conditions besides ulcerative colitis that may influence QoL.
2. Individuals participating in other interventional studies such as physician-investigator initiated clinical trials
3. The study investigator, any researcher member or aforementioned close relatives, as well as any reporting members of researchers (or their close relatives)
4. Individuals with prior registration for this study
5. Any individual the study investigator or researcher deems ineligible
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kaoru Yamabe
Organization Takeda Pharmaceuticals Company Limited
Division name Japan Pharma Business Unit Healthcare Policy & Access
Zip code
Address 2-12-10 Nihonbashi, Chuo-ku, Tokyo, Japan 103-8668
TEL +81-080-9305-8320
Email kaoru.yamabe@takeda.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiromasa Takahashi
Organization CMIC Company Limited
Division name Academic clinical research headquarters
Zip code
Address 1-1-1 Shibaura Hamamatsucho building, Minato-ku, Tokyo, 105-0023
TEL +81-090-5788-5787
Homepage URL
Email hiromasa-takahashi@cmic.co.jp

Sponsor
Institute Takeda Pharmaceuticals Company Limited

Japan Pharma Business Unit Healthcare Policy & Access
Institute
Department

Funding Source
Organization Takeda Pharmaceuticals Company Limited
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
Address
Tel
Email

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
2017 Year 06 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study was developed to understand how disease severity of Ulcerative Colitis may influence patient QoL, which would be important information for disease treatment or management.

Management information
Registered date
2017 Year 06 Month 14 Day
Last modified on
2017 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031795

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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