Clinical Trial: Sildenafil For Meniere's Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Vertigo Response (4 x 6 point scale); Balance (6 point scale)

Original Primary Outcome:

  • Primary Endpoints
  • 1. Vertigo Response (4 x 6 point scale)
  • 2. Balance (6 point scale)


Current Secondary Outcome: 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

Original Secondary Outcome:

  • 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


Information By: Pfizer

Dates:
Date Received: September 1, 2005
Date Started: June 2002
Date Completion:
Last Updated: January 30, 2008
Last Verified: January 2008