Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00145483 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 180 |
Study Start Date: | June 2002 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Study ID Numbers: | A1481107 |
Study First Received: | September 1, 2005 |
Last Updated: | January 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00145483 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Otorhinolaryngologic Diseases Meniere Disease Edema Sildenafil Ear Diseases |
Vasodilator Agents Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Therapeutic Uses Endolymphatic Hydrops |
Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Labyrinth Diseases |