Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets

Alvogen

Status and phase: Completed; Phase 4

Conditions: Meniere's Disease

Treatments: Drug: Isobide; Drug: Meniace

Study type: Interventional

Funder types: Industry

Identifiers

NCT02718846

KW-ISOBIDE_P4

Details and patient eligibility

About

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

Enrollment: 220 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Meniace and Isobide

Experimental group

Description:

co-administration Isobide solution and Meniace tablets

Treatment:

Drug: Isobide

Drug: Meniace

Meniace

Active Comparator group

Description:

single administration Meniace tablets

Treatment:

Drug: Meniace