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	Intervention	Phase
Meniere''''s Disease	Drug: Sildenafil	Phase II

Further Study Details: 

Primary Outcomes: Primary Endpoints; 1. Vertigo Response (4 x 6 point scale); 2. Balance (6 point scale)
Secondary Outcomes: Secondary Efficacy Variables: 1. Hearing/Tinnitus (6 point scale); 2. Ear, Nose and Pressure/Fullness (6 point scale); 3. Performing daily activities (6 point scale); 4. Nausea (Y/N); 5. Vomiting (Y/N); 6. Functional Response (4 point scale); 7. Duration of the
Expected Total Enrollment:  180

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00145483

Pfizer CT.gov Call Center      1-800-718-1021 

Australia, New South Wales
      Pfizer Investigational Site, Bondi Junction,  New South Wales,  2022,  Australia; Recruiting
Australia, Queensland
      Pfizer Investigational Site, Brisbane,  Queensland,  4000,  Australia; Recruiting
      Pfizer Investigational Site, Brisbane,  Queensland,  4000,  Australia; Completed
      Pfizer Investigational Site, Brisbane,  Queensland,  4000,  Australia; Recruiting
      Pfizer Investigational Site, Brisbane,  Queensland,  4000,  Australia; Recruiting
      Pfizer Investigational Site, Brisbane,  Queensland,  4000,  Australia; Recruiting
      Pfizer Investigational Site, Brisbane,  Queensland,  4000,  Australia; Recruiting
      Pfizer Investigational Site, Brisbane,  Queensland,  4000,  Australia; Recruiting
      Pfizer Investigational Site, Brisbane,  Queensland,  4000,  Australia; Recruiting
Australia, Victoria
      Pfizer Investigational Site, East Melbourne,  Victoria,  3002,  Australia; Recruiting
      Pfizer Investigational Site, Melbourne,  Victoria,  3004,  Australia; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A1481107
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00145483
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
ClinicalTrials.gov processed this record on 2005-09-06