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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02718846
Other study ID # KW-ISOBIDE_P4
Secondary ID
Status Completed
Phase Phase 4
First received March 21, 2016
Last updated March 23, 2016
Start date February 2013
Est. completion date May 2015

Study information

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

Clinical Trial 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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Meniace
6 mg of Meniace tablets were administered 3 times per day after meals
Isobide
an initial dosage of 90 mL of Isobide solution was administered orally 3 times a day after meals

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alvogen Korea

Outcome

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
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