- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00145483
Sildenafil For Meniere's Disease
January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
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 Overview
Study Type
Interventional
Enrollment (Actual)
163
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Bondi Junction, New South Wales, Australia
- Pfizer Investigational Site
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Queensland
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Brisbane, Queensland, Australia
- Pfizer Investigational Site
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Victoria
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East Melbourne, Victoria, Australia
- Pfizer Investigational Site
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Melbourne, Victoria, Australia
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Vertigo Response (4 x 6 point scale); Balance (6 point scale)
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Secondary Outcome Measures
Outcome Measure |
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 18, 2002
Primary Completion (Actual)
November 8, 2006
Study Completion (Actual)
November 8, 2006
Study Registration Dates
First Submitted
September 1, 2005
First Submitted That Met QC Criteria
September 1, 2005
First Posted (Estimate)
September 5, 2005
Study Record Updates
Last Update Posted (Actual)
February 1, 2021
Last Update Submitted That Met QC Criteria
January 28, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A1481107
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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