Meniere's Disease Clinical Trial
Official title:
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
Verified date | March 2016 |
Source | Alvogen Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Ministry of Food and Drug Safety |
Study type | Interventional |
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
Status | Completed |
Enrollment | 220 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
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 - A patient with severe heart failure (New York Heart Association class III or higher) - A patient with an adrenal tumor - A patient with pheochromocytoma - A patient who is hypersensitive to the ingredients of the test and control drugs - A patient with a hereditary disease such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption - A woman who is pregnant or breastfeeding - A patient who is deemed ineligible for this clinical study by the analyst |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Alvogen Korea |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the number of vertigo episodes | The difference between the number of vertigo episodes experienced during the 4 weeks before the screening and the number of vertigo episodes during the 4 weeks after administration of the study drug | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06001593 -
Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation
|
Phase 1/Phase 2 | |
Completed |
NCT03325790 -
SPI-1005 for the Treatment of Patients With Meniere's Disease
|
Phase 2 | |
Completed |
NCT02612337 -
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
|
Phase 3 | |
Completed |
NCT02265393 -
A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
|
Phase 2 | |
Completed |
NCT02309099 -
Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach
|
N/A | |
Completed |
NCT01412177 -
OTO-104 for the Treatment of Meniere's Disease
|
Phase 2 | |
Terminated |
NCT02717442 -
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
|
Phase 3 | |
Completed |
NCT01084525 -
OTO-104 for Meniere's Disease
|
Phase 1 | |
Terminated |
NCT02530931 -
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease
|
Phase 4 | |
Terminated |
NCT02740387 -
Open Label Study of OTO-104 in Subjects With Meniere's Disease
|
Phase 2 | |
Completed |
NCT02158585 -
Study of Lamotrigine to Treat Ménière's Disease
|
Phase 2 | |
Completed |
NCT00145483 -
Sildenafil For Meniere's Disease
|
Phase 4 | |
Suspended |
NCT04026516 -
CAVA: Dizziness Trial
|
N/A | |
Recruiting |
NCT03587701 -
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
|
Phase 2 | |
Completed |
NCT02080312 -
Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
|
N/A | |
Completed |
NCT01454726 -
Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease
|
Phase 3 | |
Recruiting |
NCT01099046 -
Stress Management Therapy for Meniere's Disease
|
N/A | |
Completed |
NCT00160238 -
Effects of Betaserc on Vestibular Compensation in Patients Suffering From Disabling Meniere's Disease and Having Undergone Vestibular Neurotomy
|
Phase 4 | |
Terminated |
NCT02706730 -
A 6-Month Extension Study of OTO-104 in Meniere's Disease
|
Phase 3 | |
Completed |
NCT02603081 -
Study to Evaluate SPI-1005 in Adults With Meniere's Disease
|
Phase 1/Phase 2 |