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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
Alvogen Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere's Disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    March 21, 2016
    Last Updated
    March 23, 2016
    Sponsor
    Alvogen Korea
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    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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