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Sildenafil For Meniere's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00145483
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : September 19, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Meniere's Disease Drug: Sildenafil Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 18, 2002
Actual Primary Completion Date : November 8, 2006
Actual Study Completion Date : November 8, 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Vertigo Response (4 x 6 point scale); Balance (6 point scale)

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00145483

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Australia, New South Wales
Pfizer Investigational Site
Bondi Junction, New South Wales, Australia
Australia, Queensland
Pfizer Investigational Site
Brisbane, Queensland, Australia
Australia, Victoria
Pfizer Investigational Site
East Melbourne, Victoria, Australia
Pfizer Investigational Site
Melbourne, Victoria, Australia
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer Identifier: NCT00145483     History of Changes
Other Study ID Numbers: A1481107
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: January 2008
Additional relevant MeSH terms:
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Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents