Commercial Lidocaine Patch as a Treatment for Ear-ringing

NCT02088866 | Completed Early Phase 1

• 1 other identifier: 515576
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Keywords

Tinnitus; Otolaryngology

Outcome Measures

Primary Outcomes (1)

• Tinnitus Functional Index (TFI) change at 4 week intervals up to a maximum time frame of 12 weeks

  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.

  At time of enrollment and every 4 weeks thereafter up to a maximum time frame of 12 weeks from date of enrollment.

Study Arms (1)

Transdermal Lidocaine

EXPERIMENTAL

All patients will be in this arm. This arm will be the transdermal lidocaine group.

Drug: Transdermal Lidocaine

Interventions

Transdermal Lidocaine DRUG

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.

Also known as: 5% Commercially Available Transdermal Lidocaine

Transdermal Lidocaine

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Department of Otolaryngology

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel C O'Brien, B.S.

  University of California Davis Department of Medical Education

  STUDY DIRECTOR

• Rodney Diaz, MD

  University of California Davis Department of Otolaryngology - Head and Neck Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 17, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)