UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043077 |
|---|---|
| Receipt number | R000049178 |
| Scientific Title | Risk of inner ear involvement in patients with inflammatory bowel disease: a population-based cohort study |
| Date of disclosure of the study information | 2021/01/21 |
| Last modified on | 2022/01/22 17:48:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Risk of inner ear involvement in patients with inflammatory bowel disease: a population-based cohort study
Acronym
inflammatory bowel disease and hearing loss/vertigo
Scientific Title
Risk of inner ear involvement in patients with inflammatory bowel disease: a population-based cohort study
Scientific Title:Acronym
inflammatory bowel disease and hearing loss/vertigo
Region
| Japan |
Condition
Condition
Hearing loss and balance disorders
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the relationship between inflammatory bowel disorders and hearing loss/dizziness.
Basic objectives2
Others
Basic objectives -Others
To reveal a prevalence of hearing loss/dizziness in patients with inflammatory bowel diseases.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A prevalence of hearing loss/dizziness in patients with inflammatory bowel diseases based on questionnaire-based survey.
Key secondary outcomes
Audiometric features of hearing loss in patients with inflammatory bowel diseases.
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
| 6 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All patients with ulcerative colitis/Crohn's disease who are under follow-up in Tokyo Medical and Dental University Hospital.
Key exclusion criteria
Patients who have difficulty in expressing willingness to participate in this clinical study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Fujikawa |
Organization
Tokyo Medical and Dental University
Division name
Otolaryngology
Zip code
113-8519
Address
1-5-45, Bunkyo-ku, Yushima, Tokyo, Japan
TEL
03-5308-5308
fujikawa.oto@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Fujikawa |
Organization
Tokyo Medical and Dental University
Division name
Otolaryngology
Zip code
113-8519
Address
1-5-45, Bunkyo-ku, Yushima, Tokyo, Japan
TEL
03-5308-5308
Homepage URL
fujikawa.oto@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University Hospital of Medicine, Clinical Research Center
Address
1-5-45, Bunkyo-ku, Yushima, Tokyo, Japan
Tel
03-5308-5612
tiken.crc@tmd.ac.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
東京医科歯科大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 21 | 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
500
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
622 patients were registered. Audiometry was performed for 421 patients.
Management information
Registered date
| 2021 | Year | 01 | Month | 21 | Day |
Last modified on
| 2022 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049178
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
