Commercial Lidocaine Patch as a Treatment for Ear-ringing
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|ClinicalTrials.gov Identifier: NCT02088866|
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Drug: Transdermal Lidocaine||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|United States, California|
|UC Davis Department of Otolaryngology|
|Sacramento, California, United States, 95817|
|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|