Meniere DiseaseNCT00599560
Vasopressin and V2 Receptor in Meniere's Disease
A study testing vasopressin, V2 receptor and cyclic AMP in people with Meniere Disease, run by Osaka University at 1 site in Japan.
Trial summary
Summary: Some of sicknesses are well known to be provoked by inadequate adaptation to physical and/or psychogenic stress in their daily life. Meniere's disease is also a common inner ear disease accompanied with vertigo, hearing loss and tinnitus especially in civilized people under stressed life style. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Meniere Disease
- What is being tested?
- vasopressin, V2 receptor and cyclic AMP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteJapan
- Study dates
- Apr 1998to Sep 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were eligible for enrollment if they had received a clinical diagnosis of Meniere's disease according to the 1995 AAO-HNS criteria (Committee, 1995). These criteria can be briefly described as follows:
- Repeated attacks of vertigo: A definitive spell is spontaneous vertigo lasting at least 20 minutes. A mixed type of spontaneous nystagmus is observed during attacks.
- Fluctuating cochlear symptoms: The hearing test usually reveals a marked fluctuation of the threshold in the low and middle tone range.
Who cannot join
- Any other neuro-otologic diseases.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Otolaryngology, Osaka University, School of Medicine
Suita, Osaka, 565-0871
About this study
Summary: Some of sicknesses are well known to be provoked by inadequate adaptation to physical and/or psychogenic stress in their daily life. Meniere's disease is also a common inner ear disease accompanied with vertigo, hearing loss and tinnitus especially in civilized people under stressed life style. Its oto-pathology was firstly revealed in 1938 to be inner ear endolymphatic hydrops through the temporal bone study. To elucidate the neuroscientific relationship between "stress" and "inner ear", we examined plasma vasopressin (the anti-diuretic "stress" hormone) and its receptor, V2R in the endolymphatic sac (the "inner ear" endo-organ for endolymph absorption) in Meniere's patients.
Read the detailed description
Methods: Between 1998 and 2006, we enrolled and assigned 105 intractable Meniere's patients to examine plasma vasopressin during remission of vertigo attacks (controls: 30 patients with chronic otitis media). Using the real-time PCR method, we examined V2R mRNA expression in the endolymphatic sac in 12 patients (controls: 6 patients with acoustic neurinoma). By means of cell culture and cyclic AMP assay, we also examined cyclic AMP activity in the endolymphatic sac in 3 patients (controls: 3 patients with acoustic neurinoma).
- Conditions
- Meniere Disease
- Being tested
- vasopressin, V2 receptor and cyclic AMP
- Keywords
- Meniere's disease, stress, vasopressin, endolymphatic sac, V2 receptor, cyclic AMP, Plasma vasopressin level and V2R mRNA expression level in the endolymphatic sac both were significantly higher in patients with Meniere's disease., In Meniere's disease, there were significant negative co-relationships between vasopressin and V2R., The cyclic AMP activity was basically up-regulated in the endolymphatic sac in Meniere's disease.., The cyclic AMP sensitivity for vasopressin was significantly elevated in the endolymphatic sac in Meniere's disease.
- Medical subject headings
- Meniere Disease, Diabetes Insipidus, Diabetes Insipidus, Nephrogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vasopressin, V2 receptor and cyclic AMPGenetic
Also called plasma vasopressin, V2 receptor, cyclic AMP
plasma vasopressin, V2 receptor, cyclic AMP
| Study group | Role | What they receive |
|---|---|---|
| 1. Meniere's disease | Experimental | Patients were eligible for enrollment if they had received a clinical diagnosis of Meniere's disease according to the 1995 AAO-HNS criteria (Committee, 1995). These criteria can be briefly described as follows: 1) Repeated attacks of vertigo: A definitive spell is spontaneous vertigo lasting at least 20 minutes. A mixed type of spontaneous nystagmus is observed during attacks. 2) Fluctuating cochlear symptoms: The hearing test usually reveals a marked fluctuation of the threshold in the low and middle tone range. Receives: Genetic: vasopressin, V2 receptor and cyclic AMP |
| 2. Acoustic neurinoma | No intervention | Diagnosed by CT and/or MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls
Measured: prospective
Secondary outcomes (1)
cyclic AMP activity in the endolymphatic sac in Meniere's disease vs controls
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startApr 1998
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meniere DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Osaka City University
- Investigators
- Tadashi Kitahara, M.D.,Ph.D., Principal investigator, Department of ORL, Osaka University, School of MedicineHiroshi Kiyama, Ph.D., Study director, Department of Neuroanatomy, Osaka City University, School of MedicineTakeshi Kubo, M.D.,Ph.D., Study chair, Department of ORL, Osaka University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599560
- Sponsor's protocol ID
- tk19661218
- Other IDs
- Osaka Univ. School of Medicine
- Status last verified
- Jan 2008
- First submitted
- 10 Jan 2008
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kumagami H, Beitz E, Wild K, Zenner HP, Ruppersberg JP, Schultz JE. Expression pattern of adenylyl cyclase isoforms in the inner ear of the rat by RT-PCR and immunochemical localization of calcineurin in the organ of Corti. Hear Res. 1999 Jun;132(1-2):69-75. doi: 10.1016/s0378-5955(99)00035-0.
PubMed 10392549
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressin and V2 Receptor in Meniere's Disease
- ClinicalTrials.gov ID
- NCT00599560
- Acronym / sponsor ID
- tk19661218
- Conditions
- Meniere Disease
- Keywords
- Meniere's disease, stress, vasopressin, endolymphatic sac, V2 receptor, cyclic AMP, Plasma vasopressin level and V2R mRNA expression level in the endolymphatic sac both were significantly higher in patients with Meniere's disease., In Meniere's disease, there were significant negative co-relationships between vasopressin and V2R.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Osaka City University
- Study start
- Apr 1998
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 23 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Summary: Some of sicknesses are well known to be provoked by inadequate adaptation to physical and/or psychogenic stress in their daily life. Meniere's disease is also a common inner ear disease accompanied with vertigo, hearing loss and tinnitus especially in civilized people under stressed life style. Its oto-pathology was firstly revealed in 1938 to be inner ear endolymphatic hydrops through the temporal bone study. To elucidate the neuroscientific relationship between "stress" and "inner ear", we examined plasma vasopressin (the anti-diuretic "stress" hormone) and its receptor, V2R in the endolymphatic sac (the "inner ear" endo-organ for endolymph absorption) in Meniere's patients.
Detailed description
Methods: Between 1998 and 2006, we enrolled and assigned 105 intractable Meniere's patients to examine plasma vasopressin during remission of vertigo attacks (controls: 30 patients with chronic otitis media). Using the real-time PCR method, we examined V2R mRNA expression in the endolymphatic sac in 12 patients (controls: 6 patients with acoustic neurinoma). By means of cell culture and cyclic AMP assay, we also examined cyclic AMP activity in the endolymphatic sac in 3 patients (controls: 3 patients with acoustic neurinoma).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Meniere's disease | Experimental | Genetic: vasopressin, V2 receptor and cyclic AMPPatients were eligible for enrollment if they had received a clinical diagnosis of Meniere's disease according to the 1995 AAO-HNS criteria (Committee, 1995). These criteria can be briefly described as follows: 1) Repeated attacks of vertigo: A definitive spell is spontaneous vertigo lasting at least 20 minutes. A mixed type of spontaneous nystagmus is observed during attacks. 2) Fluctuating cochlear symptoms: The hearing test usually reveals a marked fluctuation of the threshold in the low and middle tone range. |
| 2. Acoustic neurinoma | No intervention | –Diagnosed by CT and/or MRI |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients were eligible for enrollment if they had received a clinical diagnosis of Meniere's disease according to the 1995 AAO-HNS criteria (Committee, 1995). These criteria can be briefly described as follows:
Key exclusion criteria (1 listed)
- Any other neuro-otologic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vasopressin, V2 receptor and cyclic AMPAlso: plasma vasopressin, V2 receptor, cyclic AMPplasma vasopressin, V2 receptor, cyclic AMP | Genetic | 1. Meniere's disease |
Primary outcome
plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls
Time frame: prospective
1 secondary outcome
cyclic AMP activity in the endolymphatic sac in Meniere's disease vs controls
Time frame: prospective
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Results publication: PubMed 10392549Kumagami H, Beitz E, Wild K, Zenner HP, Ruppersberg JP, Schultz JE. Expression pattern of adenylyl cyclase isoforms in the inner ear of the rat by RT-PCR and immunochemical localization of calcineurin in the organ of Corti. Hear Res. 1999 Jun;132(1-2):69-75. doi: 10.1016/s0378-5955(99)00035-0.
- Meniere's disease group at Department of ORL, Osaka University, School of MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tadashi Kitahara, M.D.,Ph.D. principal investigator
Department of ORL, Osaka University, School of Medicine
Hiroshi Kiyama, Ph.D. study director
Department of Neuroanatomy, Osaka City University, School of Medicine
Takeshi Kubo, M.D.,Ph.D. study chair
Department of ORL, Osaka University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vasopressin, V2 receptor and cyclic AMP in people with Meniere Disease, run by Osaka University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls (time frame: prospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00599560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.