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Famvir for Treatment of Hearing in Unilateral Meniere's Disease

NCT01526408 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-04-19

Study results available
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Summary

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.

Conditions

  • Meniere's Disease

Interventions

DRUG

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).

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).

Sponsors & Collaborators

  • House Clinic, Inc.

    collaborator INDUSTRY

  • House Research Institute

    lead OTHER

Principal Investigators

  • Jennifer Derebery, MD · House Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-01-31
Completion
2015-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01526408 on ClinicalTrials.gov