NCT00145483CompletedPhase 4
A Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study Of The Efficacy and Safety Of Sildenafil Given For The Acute Treatment Of Meniere's Disease
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.4 sites in 1 country163 target enrollmentStarted: June 18, 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 163
- Locations
- 4
- Primary Endpoint
- Vertigo Response (4 x 6 point scale); Balance (6 point scale)
Study Overview
Brief Summary
Meniere's disease affects a person's sense of balance. An attack can last 20 minutes to 2 hours or longer. Symptoms include rotational vertigo, hearing loss, tinnitus and a sensation of fullness in the affected ear and may be associated with nausea and vomiting. One hypothesis is that Meniere's disease is caused by the excessive accumulation of fluid in the balance tubes within the inner ear. Sildenafil may alleviate the symptoms due to its vasodilatory activity. The purpose of this study is to assess the safety and efficacy of sildenafil (Viagra) compared with placebo on symptoms during one acute attack.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Active Meniere's disease (2 or more definitive spontaneous episodes of vertigo 20 minutes or longer, plus hearing loss on at least 1 occasion, tinnitus or aural fullness) with confirmed diagnosis
Exclusion Criteria
- •Pregnant or breast feeding females or fertile females unwilling to use agreed contraceptive methods
- •severe Meniere's diseased (more than 8 attacks per month)
- •previous ear surgery
- •intratympanic perfusions of steroids or gentamicin; requiring other medications contraindicated for Viagra (eg. nitrates)
- •with medical conditions that make Viagra contraindicated
Outcomes
Primary Outcomes
Vertigo Response (4 x 6 point scale); Balance (6 point scale)
Secondary Outcomes
- Hearing/Tinnitus; Ear, Nose & Pressure/Fullness; Perf. daily activities; Nausea; Vomiting; Func. Response; Duration of the Attack and Vertigo; Rescue Medications Use; Acceptability to subject; Composite Assessment Score; Comparison to Previous Attack
Investigators
Study Sites (4)
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