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Commercial Lidocaine Patch as a Treatment for Ear-ringing

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: NCT02088866
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
The purpose of this investigation is to evaluate if topically applied lidocaine, in the form of lidocaine patches, reduces the burden of chronic subjective tinnitus in a consistent and measurable way.

Condition or disease Intervention/treatment Phase
Tinnitus Drug: Transdermal Lidocaine Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transdermal Lidocaine as a Treatment for Tinnitus
Study Start Date : March 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: Transdermal Lidocaine
All patients will be in this arm. This arm will be the transdermal lidocaine group.
Drug: Transdermal Lidocaine
The intervention will use 5% commercially available transdermal lidocaine in clinical practice for the treatment of tinnitus. This dose will be tailored to patient preference.
Other Name: 5% Commercially Available Transdermal Lidocaine




Primary Outcome Measures :
  1. Tinnitus Functional Index (TFI) change at 4 week intervals up to a maximum time frame of 12 weeks [ Time Frame: At time of enrollment and every 4 weeks thereafter up to a maximum time frame of 12 weeks from date of enrollment. ]
    The primary study endpoint is change in tinnitus tolerance based on the tinnitus functional index. TFI will be measured at initial appointment and will be measured again at 4±1 weeks for any change in outcome, then again at 8±1 weeks for any subsequent change to outcome, and finally at 12±1 weeks follow-up for any subsequent change to outcome, up to a maximum time frame of 12 weeks from date of enrollment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age
  • History of chronic subjective tinnitus that cannot be attributed to vascular, neurologic, neoplastic or traumatic causes
  • Capable of self-applying the lidocaine patches

Exclusion Criteria:

  • History of heart disease
  • History of irregular heartbeat
  • Prior MI
  • Previous exposure to lidocaine as a treatment for tinnitus
  • An allergy to adhesives
  • Allergy to lidocaine.
  • Taking medications, herbal remedies and supplements that may interact with lidocaine, including but not limited to antivirals, benzodiazepines, and St. John's Wart
  • Known liver disease
  • Known kidney disease
  • Adults who do not speak English,
  • Adults who cannot consent for him or herself
  • Women who are pregnant,
  • Women who intend to become pregnant
  • Nursing mothers
  • Prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088866


Locations
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United States, California
UC Davis Department of Otolaryngology
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Study Director: Daniel C O'Brien, B.S. University of California Davis Department of Medical Education
Principal Investigator: Rodney Diaz, MD University of California Davis Department of Otolaryngology - Head and Neck Surgery

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02088866     History of Changes
Other Study ID Numbers: 515576
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Final data was inconclusive

Keywords provided by University of California, Davis:
Tinnitus
Otolaryngology

Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action