UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007659 |
|---|---|
| Receipt number | R000009030 |
| Scientific Title | The clinical evaluation of the middle ear pressure therapy for intractable Meniere disease. |
| Date of disclosure of the study information | 2012/05/10 |
| Last modified on | 2012/04/04 10:01:53 |
* 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
The clinical evaluation of the middle ear pressure therapy for intractable Meniere disease.
Acronym
The middle ear pressure therapy for intractable Meniere disease.
Scientific Title
The clinical evaluation of the middle ear pressure therapy for intractable Meniere disease.
Scientific Title:Acronym
The middle ear pressure therapy for intractable Meniere disease.
Region
| Japan |
Condition
Condition
Intractable Meniere disease
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical benefit of middle ear presssure therapy for intractable Meniere disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The frequency of vertigo, Functional level scale
Key secondary outcomes
DHI(dizziness handicap inventory)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
middle ear pressure tehrapy
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
| 8 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Fnctional level scale is more than 3.
Key exclusion criteria
The case without informed consent.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiyuki Goto |
Organization
NHO Tokyo Medical Center
Division name
otolaryngology
Zip code
Address
2-5-1 Higashigaoka meguro
TEL
03-3411-0111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | FUMIYUKI GOTO |
Organization
NHO TMC
Division name
otolaryngology
Zip code
Address
TEL
Homepage URL
amifumi@bc5.so-net.ne.jp
Sponsor or person
Institute
TMC
Institute
Department
Personal name
Funding Source
Organization
TMC
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 05 | Month | 10 | 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
| 2012 | Year | 04 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 04 | Day |
Last modified on
| 2012 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009030
