Vasopressin and V2 Receptor in Meniere's Disease

Meniere Disease Clinical Trial

Official title:

Vasopressin and V2 Receptor in Meniere's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599560
• Other study ID #: tk19661218
• Secondary ID: Osaka Univ. Scho
• Status: Completed
• Phase: N/A
• First received: January 10, 2008
• Last updated: March 28, 2016
• Start date: April 1998
• Est. completion date: September 2005

Study information

• Verified date: January 2008
• Source: Osaka University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Any other neuro-otologic diseases.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meniere Disease

Intervention

Genetic:
• vasopressin, V2 receptor and cyclic AMP
plasma vasopressin, V2 receptor, cyclic AMP

Locations

Country	Name	City	State
Japan	Department of Otolaryngology, Osaka University, School of Medicine	Suita-city	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Osaka University	Osaka City University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls		prospective	Yes
Secondary	cyclic AMP activity in the endolymphatic sac in Meniere's disease vs controls		prospective	Yes

External Links

•   Meniere's disease group at Department of ORL, Osaka University, School of Medicine