Back to resultsSildenafil For Meniere's Disease
Primary Purpose
Meniere's Disease
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Meniere's Disease
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Vertigo Response (4 x 6 point scale); Balance (6 point scale)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00145483
First Posted
September 1, 2005
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00145483
Brief Title
Sildenafil For Meniere's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 18, 2002 (Actual)
Primary Completion Date
November 8, 2006 (Actual)
Study Completion Date
November 8, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Primary Outcome Measure Information:
Title
Vertigo Response (4 x 6 point scale); Balance (6 point scale)
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bondi Junction
State/Province
New South Wales
Country
Australia
Facility Name
Pfizer Investigational Site
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Pfizer Investigational Site
City
East Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Pfizer Investigational Site
City
Melbourne
State/Province
Victoria
Country
Australia
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481107&StudyName=Sildenafil+For+Meniere%27s+Disease+
Description
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Learn more about this trial
Sildenafil For Meniere's Disease
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