Meniere's DiseasePhase 4NCT02718846
Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets
A Phase 4 study testing Meniace and Isobide in people with Meniere's Disease, run by Alvogen Korea.
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 Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Meniere's Disease
- What is being tested?
- Meniace and Isobide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to May 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
About this study
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
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
- Conditions
- Meniere's Disease
- Being tested
- Meniace, Isobide
- Medical subject headings
- Meniere Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeniaceDrug
6 mg of Meniace tablets were administered 3 times per day after meals
IsobideDrug
an initial dosage of 90 mL of Isobide solution was administered orally 3 times a day after meals
| Study group | Role | What they receive |
|---|---|---|
| Meniace and Isobide | Experimental | co-administration Isobide solution and Meniace tablets Receives: Drug: Meniace; Drug: Isobide |
| Meniace | Active comparator | single administration Meniace tablets Receives: Drug: Meniace |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of vertigo episodes
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startFeb 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniere's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvogen Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Won-ho Jeong, Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718846
- Sponsor's protocol ID
- KW-ISOBIDE_P4
- Status last verified
- Mar 2016
- First submitted
- 21 Mar 2016
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02718846
- Acronym / sponsor ID
- KW-ISOBIDE_P4
- Conditions
- Meniere's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Alvogen KoreaIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meniace and Isobide | Experimental | Drug: Meniace, Drug: Isobideco-administration Isobide solution and Meniace tablets |
| Meniace | Active comparator | Drug: Meniacesingle administration Meniace tablets |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meniace6 mg of Meniace tablets were administered 3 times per day after meals | Drug | Meniace, Meniace and Isobide |
| Isobidean initial dosage of 90 mL of Isobide solution was administered orally 3 times a day after meals | Drug | Meniace and Isobide |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won-ho Jeong, Ph.D. principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meniace and Isobide in people with Meniere's Disease, run by Alvogen Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.