Vasopressin and V2 Receptor in Meniere's Disease

What Was Tested

The trial (not phased) is built around Vasopressin.

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.

It had two arms (groups): 1. Meniere's disease (experimental) and 2. Acoustic neurinoma (no intervention).

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.

Diagnosed by CT and/or MRI.

The registry classes the interventions as genetic.

More on the Plan

Methods: Between 1998 and 2006, the researchers 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, the researchers 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, the researchers also examined cyclic AMP activity in the endolymphatic sac in 3 patients (controls: 3 patients with acoustic neurinoma).

Who Took Part

135 actual participants took part.

It was open to people of any sex aged from 20 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 1 exclusion criteria; among the exclusions: any other neuro-otologic diseases.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Vasopressin group and the comparison group ran side by side rather than switching.

Being open-label, the Vasopressin study did not mask who received what.

It started in 1998-04 with completion listed for 2005-09.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls (time frame: prospective).

It also tracked 1 secondary outcome, for example cyclic AMP activity in the endolymphatic sac in Meniere's disease vs controls.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Vasopressin in 135 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vasopressin compound page, all human trials.