Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets
Primary Purpose
Meniere's Disease
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Meniace
Isobide
Sponsored by
About this trial
This is an interventional treatment trial for Meniere's Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Meniace and Isobide
Meniace
Arm Description
co-administration Isobide solution and Meniace tablets
single administration Meniace tablets
Outcomes
Primary Outcome Measures
the number of vertigo episodes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02718846
Brief Title
Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alvogen Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meniace and Isobide
Arm Type
Experimental
Arm Description
co-administration Isobide solution and Meniace tablets
Arm Title
Meniace
Arm Type
Active Comparator
Arm Description
single administration Meniace tablets
Intervention Type
Drug
Intervention Name(s)
Meniace
Intervention Description
6 mg of Meniace tablets were administered 3 times per day after meals
Intervention Type
Drug
Intervention Name(s)
Isobide
Intervention Description
an initial dosage of 90 mL of Isobide solution was administered orally 3 times a day after meals
Primary Outcome Measure Information:
Title
the number of vertigo episodes
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won-ho Jeong, Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets
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