Sildenafil For Meniere's Disease

NCT00145483 | Completed Phase 4

• 1 other identifier: A1481107
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 4

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.

Conditions

Meniere's Disease

Outcome Measures

Primary Outcomes (1)

• Vertigo Response (4 x 6 point scale); Balance (6 point scale)

Secondary Outcomes (1)

• 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

Interventions

Sildenafil DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (4)

Pfizer Investigational Site

Bondi Junction, New South Wales, Australia

Location

Pfizer Investigational Site

Brisbane, Queensland, Australia

Location

Pfizer Investigational Site

East Melbourne, Victoria, Australia

Location

Pfizer Investigational Site

Melbourne, Victoria, Australia

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Meniere Disease

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: June 18, 2002
• Primary Completion: November 8, 2006
• Study Completion: November 8, 2006
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

AU (4)