Loading clinical trials...

COMPLETEDPHASE4

Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets

A Multicenter, Randomized, Open-label Clinical Study With a Concurrent Control Group to Assess the Effectiveness and Safety of Combined Therapy With Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets for Patients With Meniere's Disease

NCT02718846•Alvogen Korea

View on ClinicalTrials.gov

Summary

A multicenter, randomized, open-label clinical study with a concurrent control group to assess the effectiveness and safety of combined therapy with Isobide solution and Meniace tablets compared to monotherapy with Meniace tablets for patients with Meniere's disease

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•20 - 80 years of age (in full)
•A definite Meniere's disease patient according to the diagnostic criteria of AAO-HNS (1995), who has had 2 or more episodes of rotary dizziness lasting more than 20 minutes within the last 3 months (12 weeks) and 1 or more episodes of hearing loss recorded by audiometry, and has tinnitus or ear fullness.
•For female subjects with the possibility of pregnancy during the study period, a subject whose urine pregnancy test result was negative at the time of the screening visit. A subject in menopause for at least one year, one who has no possibility to become pregnant through surgery, or one who effectively uses an acceptable contraceptive measure. A subject who definitely agreed to use an adequate contraceptive measure during the clinical study period.

Exclusion Criteria

•A patient with the history of ear surgery
•A patient with the history of endolymphatic sac surgery
•A patient who used steroids or gentamycin in the eardrum within the last 6 months
•A patient to whom Isobide was administered within 3 months at the time of screening
•A patient who has an infection in the ear, paranasal sinuses or the upper airway system
•A patient who has a disease, other than Meniere's disease, that manifests as repetitive dizziness (e.g. Migrainous vertigo, vertebrobasilar transient ischemic attack, acoustic neuroma)
•A patient who has acute intracranial hematoma (If this drug is administered to a patient suspected of having an acute intracranial hematoma without checking for the existence of an intracranial hematoma, bleeding that had been stopped temporarily by brain pressure can occur again when intracranial pressure is reduced. Thus, eliminate the cause of bleeding and administer the drug after ensuring that there are no concerns of rebleeding)
•A patient with anuria (with urinary output of less than 100 mL/day)
•A severely dehydrated patient (loss of 10% or more of body weight)
•A patient with acute pulmonary edema
+7 more criteria

Key Dates

Start Date

February 1, 2013

Primary Completion Date

May 1, 2015

Completion Date

May 1, 2015

Last Updated

March 24, 2016

Enrollment

220

ACTUAL participants

Conditions

Meniere's Disease

Interventions

Meniace

DRUG

Isobide

DRUG

SPI-1005 for the Treatment of Meniere's Disease (Open Label)

NCT06859788

Meniere's DiseaseMénière's Disease

View study

TERMINATEDPHASE3

A 6-Month Extension Study of OTO-104 in Meniere's Disease

NCT02768662

Meniere's Disease

View study

TERMINATEDPHASE4

Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets

Inclusion Criteria

Exclusion Criteria

SPI-1005 for the Treatment of Meniere's Disease (Open Label)

A 6-Month Extension Study of OTO-104 in Meniere's Disease

Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

Open Label Study of OTO-104 in Subjects With Meniere's Disease

OTO-104 for the Treatment of Meniere's Disease

Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease