Famvir for Treatment of Hearing in Unilateral Meniere's Disease

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-03-31

Brief Summary

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The specific aim of this study is to determine the efficacy of treatment with famciclovir in unilateral Meniere's Disease patients, specifically whether hearing can be improved. The investigators will determine the percentage of unilateral Meniere's Disease patients experiencing an absence of hearing fluctuation after 3 months of treatment with famciclovir as compared to the placebo arm.

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Detailed Description

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Conditions

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Meniere's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo Arm

Treatment with 3 months of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months).

Active Arm

Treatment with 3 months of active drug

Group Type ACTIVE_COMPARATOR

Famciclovir

Intervention Type DRUG

Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug).

Interventions

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Famciclovir

Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug).

Intervention Type DRUG

Placebo

Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months).

Intervention Type DRUG

Other Intervention Names

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Famvir

Eligibility Criteria

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Inclusion Criteria

* Unilateral Meniere's Disease
* 2 vertigo episodes of at least 20 minutes
* Fluctuating hearing by subjective history and/or audiometric documentation. Audiometric documentation is defined as affected ear pure-tone average change from an audiogram at Time 1 to Time 2 (less than one year apart) of greater than 15 dB.
* Less than 45 dB 4-frequency pure-tone average in the affected ear
* Tinnitus and/or aural fullness
* Willing to undergo the clinical trial procedures
* Signed informed consent

Exclusion Criteria

* Acute or chronic middle ear disease in either ear
* Only hearing ear
* 4-frequency pure-tone average \> 45 dB in either ear
* Known allergy to famciclovir or any of the ingredients in the formulation
* Taking oral steroids or receiving IT steroids at time of enrollment. If the subject has been on oral steroids/IT steroids, 3 months must elapse from last dose to start of treatment in the study
* Must not have had previous inner ear surgery
* History of immunodeficiency diseases such as HIV
* History of renal insufficiency or other kidney diseases
* A female of child-bearing potential who is pregnant
* History of noncompliance to medical regimens
* Unwilling to or unable to comply with the protocol, including scheduling study evaluations

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No