Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-13 @ 5:48 PM
Study NCT ID:
NCT00599560
Status:
COMPLETED
Last Update Posted:
2016-03-29
First Post:
2008-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vasopressin and V2 Receptor in Meniere's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008575', 'term': 'Meniere Disease'}, {'id': 'D003919', 'term': 'Diabetes Insipidus'}, {'id': 'D018500', 'term': 'Diabetes Insipidus, Nephrogenic'}], 'ancestors': [{'id': 'D018159', 'term': 'Endolymphatic Hydrops'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D017483', 'term': 'Receptors, Vasopressin'}, {'id': 'D000242', 'term': 'Cyclic AMP'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D043562', 'term': 'Receptors, G-Protein-Coupled'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D018013', 'term': 'Receptors, Neuropeptide'}, {'id': 'D017981', 'term': 'Receptors, Neurotransmitter'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}, {'id': 'D011979', 'term': 'Receptors, Pituitary Hormone'}, {'id': 'D000227', 'term': 'Adenine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009712', 'term': 'Nucleotides, Cyclic'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-28', 'studyFirstSubmitDate': '2008-01-10', 'studyFirstSubmitQcDate': '2008-01-22', 'lastUpdatePostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "plasma vasopressin level and V2 receptor mRNA in the endolymphatic sac in Meniere's disease vs controls", 'timeFrame': 'prospective'}], 'secondaryOutcomes': [{'measure': "cyclic AMP activity in the endolymphatic sac in Meniere's disease vs controls", 'timeFrame': 'prospective'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'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."], 'conditions': ['Meniere Disease']}, 'referencesModule': {'references': [{'pmid': '10392549', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.med.osaka-u.ac.jp/pub/ent/r_vertigo.html', 'label': "Meniere's disease group at Department of ORL, Osaka University, School of Medicine"}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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:\n\n 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.\n 2. Fluctuating cochlear symptoms: The hearing test usually reveals a marked fluctuation of the threshold in the low and middle tone range.\n\nExclusion Criteria:\n\n* Any other neuro-otologic diseases."}, 'identificationModule': {'nctId': 'NCT00599560', 'briefTitle': "Vasopressin and V2 Receptor in Meniere's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Osaka University'}, 'officialTitle': "Vasopressin and V2 Receptor in Meniere's Disease", 'orgStudyIdInfo': {'id': 'tk19661218'}, 'secondaryIdInfos': [{'id': 'Osaka Univ. School of Medicine'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "1. Meniere's disease", 'description': "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.", 'interventionNames': ['Genetic: vasopressin, V2 receptor and cyclic AMP']}, {'type': 'NO_INTERVENTION', 'label': '2. Acoustic neurinoma', 'description': 'Diagnosed by CT and/or MRI'}], 'interventions': [{'name': 'vasopressin, V2 receptor and cyclic AMP', 'type': 'GENETIC', 'otherNames': ['plasma vasopressin', 'V2 receptor', 'cyclic AMP'], 'description': 'plasma vasopressin, V2 receptor, cyclic AMP', 'armGroupLabels': ["1. Meniere's disease"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '565-0871', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Department of Otolaryngology, Osaka University, School of Medicine', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}], 'overallOfficials': [{'name': 'Tadashi Kitahara, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of ORL, Osaka University, School of Medicine'}, {'name': 'Hiroshi Kiyama, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Neuroanatomy, Osaka City University, School of Medicine'}, {'name': 'Takeshi Kubo, M.D.,Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of ORL, Osaka University, School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osaka University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Osaka City University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': "Meniere's disease association at Osaka University", 'oldOrganization': 'Tadashi Kitahara, M.D.,Ph.D.'}}}}