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Sildenafil For Meniere's Disease

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NCT00145483

Last updated on November 14, 2019
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Study Location
Pfizer Investigational Site
Bondi Junction, New South Wales, Australia
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meniere's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00145483
Pfizer
Completed
Sildenafil For Meniere's Disease

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Descriptive Information
Brief Title  ICMJE Sildenafil For Meniere's Disease
Official Title  ICMJE 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
Brief SummaryMeniere'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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Meniere's Disease
Intervention  ICMJE Drug: Sildenafil
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2018)		163
Original Enrollment  ICMJE
 (submitted: September 1, 2005)		180
Actual Study Completion Date  ICMJE November 8, 2006
Actual Primary Completion DateNovember 8, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00145483
Other Study ID Numbers  ICMJE A1481107
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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