UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017710 |
|---|---|
| Receipt number | R000020518 |
| Scientific Title | Efficacy of middle ear pressure therapy in patients with intractable Meniere's disease and delayed endolymphatic hydrops |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2018/03/24 11:22:45 |
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Basic information
Public title
Efficacy of middle ear pressure therapy in patients with intractable Meniere's disease and delayed endolymphatic hydrops
Acronym
Efficacy of middle ear pressure therapy in patients with intractable Meniere's disease and delayed endolymphatic hydrops
Scientific Title
Efficacy of middle ear pressure therapy in patients with intractable Meniere's disease and delayed endolymphatic hydrops
Scientific Title:Acronym
Efficacy of middle ear pressure therapy in patients with intractable Meniere's disease and delayed endolymphatic hydrops
Region
| Japan |
Condition
Condition
Meniere's disease, delayed endolymphatic hydrops
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An attempt was made to examine the efficacy of middle ear pressure therapy in patients with intractable Meniere's disease and delayed endolymphatic hydrops.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Monthly-averaged frequency of vertigo attack
Key secondary outcomes
Vestibular and auditory functions
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
The 3 min-application of positive-negative pressure to the external auditory canal with the middle ear pressure therapy device t.i.d. for 16 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult (20-80 y/o) patients with intractable definite Meniere's disease and delayed endolymphatic hydrops
Key exclusion criteria
1) Patients with otitis media.
2) Patients with cardiac pacemaker and implantable cardiac defibrillator.
3) Patients with diseases of the auricle and external auditory canal.
4) Patients who was excluded by investigators.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki Takeda |
Organization
University of Tokushima School of Medicine
Division name
Department of Otolaryngology
Zip code
Address
3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
088-633-7169
takeda@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriaki Takeda |
Organization
University of Tokushima School of Medicine
Division name
Department of Otolaryngology
Zip code
Address
3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
088-633-7169
Homepage URL
takeda@tokushima-u.ac.jp
Sponsor or person
Institute
University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid from the Japan Agency for Medical Research and Development
Organization
Division
Category of Funding 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
| 2015 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | 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
| 2015 | Year | 05 | Month | 27 | Day |
Last modified on
| 2018 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020518
