UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027750 |
|---|---|
| Receipt number | 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 11:22:32 |
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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
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
hiromasa-takahashi@cmic.co.jp
Sponsor or person
Institute
Takeda Pharmaceuticals Company Limited
Japan Pharma Business Unit Healthcare Policy & Access
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031795
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
