Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02088866 |
| Other study ID # |
515576 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Early Phase 1
|
| First received |
March 11, 2014 |
| Last updated |
May 24, 2017 |
| Start date |
March 2014 |
| Est. completion date |
September 2015 |
Study information
| Verified date |
May 2017 |
| Source |
University of California, Davis |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Potential research participants will be recruited from the UC Davis Otolaryngology clinic.
For this investigation, the investigators will be using the Tinnitus Functional Index, a
standardized and validated survey for the impact of tinnitus on an individual's life. The
study design will be an unblinded, quasi-experimental protocol to ascertain if transdermal
lidocaine can reduce subjective tinnitus. This initial investigation will be studying the
efficacy of 5% transdermal lidocaine patches in the treatment of tinnitus. Transdermal
lidocaine is currently approved by the FDA for the treatment of post-herpetic neuralgia, but
it is used off label for a wide assortment of conditions. The investigators will be
following the guidelines used for the general use of transdermal lidocaine and will remain
within the dosing approved by the FDA. The investigators intend to sequentially recruit 44
participants for this study, in the order that they present to the UC Davis Otolaryngology
clinic.
SUBJECTS Eligible subjects are greater than 18 years of age and have had at least a history
of chronic subjective tinnitus. Prior to enrollment, all potential subjects will be screened
to see if they meet the inclusion and exclusion criteria as listed in Section 6. Once
inclusion and exclusion criteria have been evaluated, appropriate participants will undergo
the informed consent process. Following informed consent, all selected participants will
undergo a full history and physical exam. We will not be performing a pre-enrollment EKG, as
it is not required for the general use of transdermal lidocaine. Each subject will have had
an audiogram performed as standard of care for evaluation and management of chronic
tinnitus.
MATERIALS AND APPLICATION This investigation will utilize the UC Davis Otolaryngology clinic
and its resource within for this investigation. TFI surveys will be provided for the
participants. The drug used in this investigation will be 5% lidocaine patches (Endo
Pharmaceuticals and Actavis Pharmaceuticals). Study drug will be prescribed by a physician
in the Department of the Otolaryngology at UC Davis, to be filled at the pharmacy of the
participant's choosing.
The transdermal lidocaine patches will be administered to the participant's torso, either
the upper back or chest, at his or her preference. If an individual is so slight of build
that he or she can not apply three patches to either his upper chest or upper back, then
other locations will be considered, including low back, buttocks, and thighs. Patches will
be applied first thing in the morning to these areas daily, and kept on for twelve hours.
Following patch removal at night, the patient will undergo a twelve hour drug recess off of
the transdermal lidocaine.
All relevant patient information including symptoms checklists, results of TFI, and other
important patient care information will be recorded in the UC Davis Electronic Medical
Record (EMR) for each encounter under the appropriate encounter subheading. These recording
will be done in accordance with UC Davis Policies and Procedures manual Chapter 320, Section
10 Records and Archives: Records Management Program, as well as UC Davis Health Center's
Code of Conduct, specifically referring to Standards 6, Creation and Retention of an
Accurate Patient and Institutional Record, and 14, Clinical Research. The patient data will
also be transposed into a REDCap database for patient tracking, evaluation, and analysis.
STUDY VISITS After the completion of the informed consent, each individual will be asked to
complete the tinnitus functional index. If he or she does not have a baseline audiogram on
record, they will be referred to the Audiology Clinic for this in accordance with standard
of care for tinnitus. Using a previously created dot phrase in the EMR, the results of the
TFI and the symptom checklist will be recorded into the participant's health record.
Following completion of the tinnitus functional index, each participant will be prescribed
thirty transdermal lidocaine patches, so that one patch can be applied daily for 12 hours,
as indicated by the manufacturer. The participant will be asked to follow-up in 4 weeks by
phone.
All subjects will be enrolled sequentially and assigned a schedule that works best with his
or her ability to follow-up. As such, for this pilot study there will not be any cohort
assignment outside of the treatment group. Each participant will continue with either the
baseline dosage or an increased dosage based upon his or her response and tolerance to the
drug. For this quasi-experimental model, we will not be using controls and will compare
final results to baseline measurements.
After one month of treatment, the participant will be called by the research team. During
this telephone call, the participant will first be asked if he or she would like to
withdrawal from the study. This individual will then be asked to voice any and all concerns
he or she may have up to that point in the study. During these calls, the participant will
be asked the same questions he or she answered during the initial visit, including those of
the TFI and the symptoms checklist. These results will be recorded in the EMR as a phone
interaction, using the previously developed dot phrases. At the time of the call, the
participant will be asked how many patches he or she has remaining from the previous month.
These left over patches will be recorded as well in the EMR. At the conclusion of this first
follow-up call, the participant will either continue the baseline dosage or have dosing
increased to two transdermal lidocaine patches. These patches will again be applied to the
upper back or shoulder 12 hours of each day. Patch application techniques will be similar to
that of the first patch, but if he or she has any concerns about application of the patches
he or she can ask the research team at any time for advice or guidance. We anticipate this
follow-up call will take 30 minutes or less.
At the end of this second 4 week period, 8 total study weeks, the participant will again be
called by the research team and asked questions in a similar manner to the first follow-up
phone call. During this telephone encounter, the patient will be asked if he or she would
like to withdrawal from the study, and /or if he or she has any concerns. The participant
will then be asked the same questions he or she answered during the initial visit, including
the TFI and the symptoms checklist. The results will again be recorded in the EMR as a phone
interaction, using the previously developed dot phrases. At the time of the call, the
participant will be asked how many patches he or she has remaining from the previous month.
These left over patches will be recorded as well in the EMR. At the conclusion of this
follow-up call, the participant will have the opportunity to continue current therapy, or to
increase his or her current regimen by a patch. This change would increase the total dose to
either 2 or 3 transdermal lidocaine patches based upon his or her previous therapy. The
patches will again be applied to the upper back or shoulder 12 hours of each day. Patch
application techniques will be similar to that of the first patch, but if he or she has any
concerns about application of the patches he or she can ask the research team at any time
for advice or guidance. We anticipate this follow-up call will take 30 minutes or less.
Following the third month of the study, 12 total study weeks, the participant will be asked
to follow up in the UC Davis Otolaryngology clinic, and he or she will be seen in one of the
clinical suites. The participant will have the opportunity to voice any concerns he or she
may have with the trial. At this visits the participant will be asked again to complete the
TFI, a symptoms checklist, report the number of patches he or she used over the previous
month, and to undergo a focused physical examination of his or her head, neck, and
cardiovascular system. The results of these questionnaires and exams will be recorded in the
EMR. Following these repeat evaluations, the participant's results of the TFI will be
reviewed. After reviewing these results, the participant will have the opportunity to
continue the most effective dose of the medication for him or her, based on his or her
symptoms and side effects.
The above protocol will be followed unless the participant develops toxic effects of the
lidocaine patches including but not limited to palpitations, chest pain, irregular heart
beat (as diagnosed by either his or her primary care physician or other health care
provider), severe allergic reactions, severe vestibular symptoms including severe dizziness,
intractable nausea, or blurred vision. In such an occurrence the participant will be removed
from the study. If a participant develops these or other concerning symptoms, they will be
immediately referred to the emergency room for evaluation and treatment. The onset of these
symptoms as well as the dosing at which they were experienced will be recorded for
statistical analysis. A participant may also be removed from the study if they have an
adverse event unrelated to the study including hospitalization for major illness or injury.
The data that he or she contributed up until removal from the study will remain within the
study and be evaluated on an intent to treat basis.
If the participant has an adverse event following the increase of the dose of transdermal
lidocaine he or she will be presented with two options. If he or she previously tolerated a
lower dosage of the transdermal lidocaine, and would like to return to that dose, following
the adverse event, he or she will have the option of returning to that regimen. He or she
will also be presented with the option of treatment cessation following their adverse event.
Their decision will be recorded and their data treated accordingly.
A participant will be informed of his or her results from the survey at his or her request,
as well as at the completion of the third month of follow-up. The results will be reviewed
by one of the investigators with the participant, allowing adequate time for interpretation
and questions.
The data will be stored in three locations. The participant's informed consent documents
will be scanned into the EMR, the participant will be asked to keep a copy of these forms,
and we will keep the original hard copy forms in a secured drawer in the back of the
Otolaryngology clinic, away from clinical activity. The participant will be asked to fill
out paper copies of the TFI, and symptom checklist at the final clinical appointment, and
these will be immediately transposed into the EMR. Once transposed, the paper copies of the
TFI and symptom checklist will disposed of in secure shredding bins. All data will be stored
in the REDCap database and available to only to the investigating team.
