Trial Outcomes & Findings for Famvir for Treatment of Hearing in Unilateral Meniere's Disease (NCT NCT01526408)
NCT ID: NCT01526408
Last Updated: 2021-04-19
Results Overview
Change in hearing from baseline to after 3 months of treatment
TERMINATED
PHASE3
11 participants
3 months
2021-04-19
Participant Flow
Participant milestones
| Measure |
Placebo Arm
Treatment with 3 months of placebo
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).
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Active Arm
Treatment with 3 months of active 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).
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Overall Study
STARTED
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0
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Famvir for Treatment of Hearing in Unilateral Meniere's Disease
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 3 monthsPopulation: early termination of study and sponsor organization closed
Change in hearing from baseline to after 3 months of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: early termination of study and sponsor organization closed
Change in tinnitus and/or dizziness from baseline to after 3 months of treatment
Outcome measures
Outcome data not reported
Adverse Events
Placebo Arm
Active Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place