Lidoderm Patch (Lidocaine 5%) for Tinnitus Treatment

NCT02750969 | Unknown Phase 4 DMC

• 1 other identifier: 15-52
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators like to learn whether Lidoderm patch (lidocaine 5%) helps tinnitus patients. so far it is known that lidocaine I.V do helps tinnitus but until now it is not clear if other means of drug delivery (e.g lidocaine patch) help tinnitus. The investigators are going to compare 1 day of treatment with lidoderm patch cream Versus (VS.) tegaderm patch (containing no drug) in treating tinnitus patients.

Conditions

Tinnitus

Keywords

tinnitus; lidocain patch

Outcome Measures

Primary Outcomes (4)

• questionnaire results change- tinnitus handicap inventory

  tinnitus handicap inventory: estimates the degree that tinnitus affects patients life. It contains 25 questions. The minimum score is 0 and the maximum is 100. The investigators hypotheses that lidoderm patch treatment decreases the score of this questionnaire which means that lidoderm patch improves patients quality of life

  1 week: the time between the questionnaire results at the beginning andcompared to the results after using the tegaderm patch and the results after using the lidoderm patch

• questionnaire results- Pittsburgh sleep quality index

  Pittsburgh sleep quality index : A 9 questions exam that measure the quality of sleep. The range of results goes between 0-24. The higher the score - the worse is the quality of sleep. The investigators hypotheses states that lidoderm treatment improves the results of Pittsburgh sleep quality index

  1 week: the time between the questionnaire results at the beginning andcompared to the results after using the tegaderm patch and the results after using the lidoderm patch

• tinnitus loudness- visual analogue scale (VAS)

  Tinnitus loudness scale: A range of 1-10 scale. the patient choose which number reflects the loudness of the subjective tinnitus which the patients suffer from. the higher the number- the louder the tinnitus

  1 week: the time between the questionnaire results at the beginning andcompared to the results after using the tegaderm patch and the results after using the lidoderm patch

• tinnitus suffer - visual analogue scale (VAS)

  Tinnitus suffer scale: A range of 1-10 scale. the patient choose which number reflects the best the degree in which the tinnitus causes the patient to suffer. the higher the score- the worse is the tinnitus

  1 week: the time between the questionnaire results at the beginning andcompared to the results after using the tegaderm patch and the results after using the lidoderm patch

Study Arms (2)

1. lidoderm patches first

EXPERIMENTAL

29 tinnitus patients treated first with 3 patches of lidoderm for 1 day, for 12 consecutive hours. 60 hours after removal of the patches the patients will have 3 neutral patches (containing no drug) attach to their back for 12 hours. after the removal of each kind of patch the patient will fill 4 types of questionnaires that assess his amount of tinnitus we will compare the questionnaires results before and after the application of those patches.

Device: Lidoderm patch (Lidocaine 5% patch); Procedure: blood test- serum lidocain levels; Other: Hearing tests

2. tegaderm patches first

EXPERIMENTAL

29 tinnitus patients treated first with 3 patches of tegaderm (neutral patch containing no drug) for 1 day, for 12 consecutive hours. 60 hours after removal of the patches the patients will have 3 lidoderm patches attach to their back for 12 hours. after the removal of each kind of patch the patient will fill 4 types of questionnaires that assess his amount of tinnitus we will compare the questionnaires results before and after the application of those patches.

Other: Tegaderm patch. (neutral patch, containing no drug); Procedure: blood test- serum lidocain levels; Other: Hearing tests

Interventions

Lidoderm patch (Lidocaine 5% patch) DEVICE

The investigator will attach the patches on the patient's back for 12 consecutive hours. tinnitus questionnaires will be fulfilled by the patient before and after the patches usage . blood test for serum lidocaine level will be measured after the usage of this patch

Also known as: no other names

1. lidoderm patches first

Tegaderm patch. (neutral patch, containing no drug) OTHER

The investigator will attach the patches on the patient's back for 12 consecutive hours. tinnitus questionnaires will be fulfilled by the patient before and after the patches usage . blood test for serum lidocaine level will be measured after the usage of this patch

2. tegaderm patches first

blood test- serum lidocain levels PROCEDURE

each participant will undergo blood test. the participant's group that start the trial with the lidoderm patch and later will use the tegaderm patch will have 2 blood tests for werum lidocain level test. the group taht start the trial with the tegaderm patch and later the lidoderm patch will have only one blood test measuring lidocaine serum level. the tubes containing the serum will be shipped abroad via an international medical cargo company for lidocaine levels tests.

1. lidoderm patches first; 2. tegaderm patches first

Hearing tests OTHER

each participant that have not done hearing test in the last 1 year previous to the trial will have one in the first day of the trial.

1. lidoderm patches first; 2. tegaderm patches first

Eligibility Criteria

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

You may qualify if:

• mature (above 18 years old) patients that suffer at least 1 year of tinnitus (unilateral/bilateral

You may not qualify if:

• Intermittent/ fluctuative type of tinnitus
• patients that are treated for tinnitus( psychological treatment, hearing aid, drugs, sound generator) or were treated in the last month
• sensitivity to amide anaesthetic
• known hepatic failure
• usage of antiarrhythmic drugs of type 1
• history of seizures
• pregnancy/ lactating
• dermatologic problems in the back
• any patients that develops during the trial local/ systemic symptoms such as rash, pain, itching, fever, nervousness,palpitations will be omitted from the study
• beck depression score of \>21
• MMSE test \<24

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Haemek Medical Center

Afula, Israel

RECRUITING

MeSH Terms

Conditions

Tinnitus

Interventions

Transdermal Patch; Hearing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Avi Shupak, MD

  "LIN" MEDICAL CENTER

  STUDY DIRECTOR

Central Study Contacts

Miki Paker, MD

CONTACT

972-526596552; chiefmiki2014@gmail.com

Salim Mazzawi, MD

CONTACT

972544393994; Sali_ma@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: April 26, 2016
• Study Start: April 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)