UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035731 |
|---|---|
| Receipt number | R000040704 |
| Scientific Title | Internet survey of patient concerns with ulcerative colitis |
| Date of disclosure of the study information | 2019/01/31 |
| Last modified on | 2019/05/30 12:20:20 |
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Basic information
Public title
Internet survey of patient concerns with ulcerative colitis
Acronym
Internet survey of patient concerns with ulcerative colitis
Scientific Title
Internet survey of patient concerns with ulcerative colitis
Scientific Title:Acronym
Internet survey of patient concerns with ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conduct a web survey to identify some problems in patients with ulcerative colitis, and their expectations for the consultation with healthcare professionals and the effect of topical formulations.
Basic objectives2
Others
Basic objectives -Others
Conduct a web survey to identify the main symptoms such as urgency of defecation or fecal incontinence, and other problems with ulcerative colitis in each disease types.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Some problems in patients with ulcerative colitis
Key secondary outcomes
Types of therapeutic treatments and satisfaction of treatment forulcerative colitis
Influence of ulcerative colitis on daily living
Patients' communication with healthcare professionals, and their involvement in care decisions
Experience with topical formulations
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ulcerative colitis
Patients visiting medical institution for treatment of ulcerative colitis within the past 1 year, and regularly receiving outpatient treatment
Key exclusion criteria
No specific criteria
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Aruse |
Organization
Qlife CO.,LTD
Division name
Representative Director and CEO
Zip code
105-0001
Address
7th Floor, Sumitomo Shin-Toranomon Bldg., 4-3-9 Toranomon, Minato-ku, Tokyo
TEL
03-6860-5020
k-aruse@qlife.co.jp
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Kitahara |
Organization
QLife Co., Ltd.
Division name
Medical Solution
Zip code
105-0001
Address
7th Floor, Sumitomo Shin-Toranomon Bldg., 4-3-9 Toranomon, Minato-ku, Tokyo
TEL
03-6860-5020
Homepage URL
y-kitahara@qlife.co.jp
Sponsor or person
Institute
QLife Co., Ltd.
Medical Solution
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co.,Ltd
KISSEI 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
Mebix
Address
1-11-44 Akasaka Intercity, Akasaka, Minato-ku, Tokyo
Tel
03-4362-4504
no-mori@mebix.co.jp
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
| 2019 | Year | 01 | Month | 31 | 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
509
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
| 2018 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 26 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 26 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
nothing special
Management information
Registered date
| 2019 | Year | 01 | Month | 31 | Day |
Last modified on
| 2019 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040704
