Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00145483
Previous Study | Return to List | Next Study

Sildenafil For Meniere's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00145483
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 1, 2005
First Posted Date  ICMJE September 5, 2005
Last Update Posted Date September 19, 2018
Actual Study Start Date  ICMJE June 18, 2002
Actual Primary Completion Date November 8, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2005)
Vertigo Response (4 x 6 point scale); Balance (6 point scale)
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
  • Primary Endpoints
  • 1. Vertigo Response (4 x 6 point scale)
  • 2. Balance (6 point scale)
Change History Complete list of historical versions of study NCT00145483 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2005)
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 Measures  ICMJE
 (submitted: September 1, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 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 Description Not 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 Date November 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 Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP