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Validating a New Non-invasive Approach to Testing Lidocaine Effectiveness

Sponsor
PhenoSolve, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03680885
Collaborator
Jacobi Medical Center (Other)
20
Enrollment
1
Location
2
Arms
8
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This work will assess the reliability of a simple painless test for the effectiveness of the commonly used local anesthetic lidocaine

Condition or Disease Intervention/Treatment Phase
  • Drug: Lidocaine gel
  • Drug: Placebo
  • Drug: Injected lidocaine
 Early Phase 1

Detailed Description

In prior tests with a convenience sample, subjects who reported that they had no trouble getting numb at the dentist, also got numb with lidocaine gel on the surface of the tongue. That numbness prevented them from being able to taste any flavor until the numbness had worn off. Subjects who reported having trouble getting numb at the dentist, could still taste flavors after the application of lidocaine.

This work will assess the reliability of a taste-based approach for creating a non-invasive way to test lidocaine effectiveness. The controlled trial will assess the ability of lidocaine oral gel to block taste (e.g., sweet) in 20 adults (ages 18-49) half with history of trouble getting numb at the dentist (Arm 2) and half with no trouble (Arm 1). To determine reproducibility, the taste-based test will be done 4 times on different days, twice with lidocaine and twice with a placebo, with randomization and double-blinding. These repeated results will be compared to a fifth assessment, against the "gold standard" of injection of lidocaine, assessed using a dental probe.

On each of four separate visits, in randomized order, the subject will be tested with tastants to the tongue twice after application of a lidocaine gel to the tongue and twice with a placebo gel. After a wait of two-minutes, the three tastants will be tested. The subject is blinded to the taste and the identity of the gel, which have been compounded to look the same.

On the fifth (last) visit, the subject will get an oral injection of lidocaine and the numbness assessed.

The results across the five tests will then be analyzed.

We are testing in separate studies NCT 03563573 and NCT 03676725 the prevalence of lidocaine ineffectiveness in those with Attention Deficit Hyperactivity Disorder (ADHD) and in the general population without ADHD. We believe the prevalence will be higher in ADHD. As a result, in this evaluation we have one Arm "gets numb at the dentist" where exclusion criteria includes ADHD and a second Arm "has trouble getting numb at the dentist" that does not have that exclusion.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Half the subjects will have a self-reported history of lidocaine working for them (effective) and half will have a history of difficulty getting numb (ineffective).Half the subjects will have a self-reported history of lidocaine working for them (effective) and half will have a history of difficulty getting numb (ineffective).
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The scoring of the lidocaine test is masked, using the coded identity of the tastes. The tastes will be assessed in random order. Each subject will have 2 tests with lidocaine gel and 2 with a placebo gel, in random order, each on different days. The subjects and other study personnel will be told not to discuss what the subject could or couldn't taste. Scoring will be done only after all testing on the subject is complete. A person not involved in the testing will keep track of which gels the subject has had.
Primary Purpose:
Health Services Research
Official Title:
Reliability Testing of a Non-invasive, Pain-free, Taste-based Assessment Approach to Lidocaine Effectiveness
Actual Study Start Date :
Aug 1, 2019
Actual Primary Completion Date :
Mar 30, 2020
Actual Study Completion Date :
Mar 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Reports getting numb at dentist

Subjects will be tested twice with lidocaine gel, twice with a Placebo and once with Injected Lidocaine to assess effectiveness of lidocaine. Each assessment will be on a different day.

Drug: Lidocaine gel
Lidocaine gel 5%, PEG with FD&C Blue No.1 (Brilliant Blue FCF)
Other Names:
  • Intervention

    • Drug: Placebo
    PEG with FD&C Blue No.1 (Brilliant Blue FCF)
    Other Names:
  • Control gel

    • Drug: Injected lidocaine
    Standard FDA-approved dental injectable lidocaine
    Other Names:
  • Current practice

    		•
    Active Comparator: Reports trouble getting numb at dentist

    Subjects will be tested twice with lidocaine gel, twice with a Placebo and once with Injected Lidocaine to assess effectiveness of lidocaine. Each assessment will be on a different day.

    Drug: Lidocaine gel
    Lidocaine gel 5%, PEG with FD&C Blue No.1 (Brilliant Blue FCF)
    Other Names:
  • Intervention

    • Drug: Placebo
    PEG with FD&C Blue No.1 (Brilliant Blue FCF)
    Other Names:
  • Control gel

    • Drug: Injected lidocaine
    Standard FDA-approved dental injectable lidocaine
    Other Names:
  • Current practice

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Taste sensation after lidocaine or placebo [4 visits each of 30 minutes within weeks of one another, average ~1 month total]

      The subject is blinded to the tastant and gel identities. The 3 tastants are tested in randomized order. After application of lidocaine gel or placebo to the tongue, and a wait of 2 minutes, the subject's tongue is rubbed with a swab that has been wet with the tastant on the subject's tongue. The subject is asked to identify the taste (e.g., sweet). Then, on a 5-point scale (0-4, ranging from none to very intense) they are asked to rate the intensity of the taste. The process is repeated for each of the three tastants. The consistency of the subject responses over the 4 sessions will be analyzed.

    2. Ability to feel pressure and discomfort after injection of lidocaine into the cheek [1 visit of 30 minutes after other 4 visits, average ~1 month total]

      Inject lidocaine as would be done in a dental visit, assess numbness to pressure and discomfort using the Baker Wong FACES scale (0-10) scale of discomfort, ranging from none to intense pain. The effectiveness of lidocaine will be assessed, and then the results compared to Outcome 1.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Arm 1 Eligibility

    Inclusion Criteria:
    • Report "get numb at dentist"
    Exclusion Criteria:

    • ADHD, ADD, and other inattention disorders

    • Known adverse reactions to lidocaine;

    • Epilepsy

    • IQ <80

    • Severe head trauma

    • Birth weight <2270 grams

    • Severe autism

    • Generalized anxiety disorders (but dental-specific anxiety will not be an exclusion because many of these individuals may be ones with anxiety because of painful dental experiences with lidocaine ineffectiveness)

    • Mouth sores

    • Ehlers Danlos syndrome

    • Red hair

    • Current pregnancy

    • Treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers

    Angiotensin Converting Enzyme Inhibitors

    • Alacepril (not available in US)

    • Benazepril (Lotensin)

    • Captopril (trade name Capoten)

    • Cilazapril (Inhibace)

    • Delapril (not available in US)

    • Enalapril (Vasotec/Renitec)

    • Fosinopril (Fositen/Monopril)

    • Imidapril (Tanatril)

    • Lisinopril (Listril/Lopril/Novatec/Prinivil/Zestril)

    • Moexipril (Univasc)

    • Perindopril (Coversyl/Aceon/Perindo)

    • Quinapril (Accupril)

    • Ramipril (Altace/Prilace/Ramace/Ramiwin/Triatec/Tritace)

    • Spirapril (Renormax)

    • Temocapril (not available in US)

    • Teprotide (but not active by oral administration and not used in US)

    • Trandolapril (Mavik/Odrik/Gopten)

    • Zofenopril

    Angiotensin receptor blockers

    • Azilsartan (Edarbi)

    • Candesartan (Atacand)

    • Eprosartan (Teveten)

    • Fimasartan (Kanarb)

    • Irbesartan (Avapro)

    • Losartan (Cozaar)

    • Olmesartan (Benicar/Olmetec)

    • Telmisartan (Micardis)

    • Valsartan (Diovan)

    Aldosterone antagonists

    • Spironolactone (Aldactone)

    • Eplerenone (Inspra)

    Renin inhibitors - Aliskiren (Tekturna, Rasilez)

    Other potassium elevating agents

    • Antibiotics, including penicillin G and trimethoprim

    • Azole antifungals

    • Beta-blockers

    • Herbal supplements, including milkweed, lily of the valley, Siberian ginseng, Hawthorn berries

    • Heparin

    • Nonsteroidal anti-inflammatory medications (NSAIDs)

    • Oral contraceptives containing drospirenone

    Arm 2 Eligibility

    Inclusion Criteria:
    • Report "trouble getting numb at dentist"
    Exclusion Criteria:

    • Known adverse reactions to lidocaine;

    • Epilepsy

    • IQ <80

    • Severe head trauma

    • Birth weight <2270 grams

    • Severe autism

    • Generalized anxiety disorders (but dental-specific anxiety will not be an exclusion because many of these individuals may be ones with anxiety because of painful dental experiences with lidocaine ineffectiveness)

    • Mouth sores

    • Ehlers Danlos syndrome

    • Red hair

    • Current pregnancy

    • Treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers

    Angiotensin Converting Enzyme Inhibitors

    • Alacepril (not available in US)

    • Benazepril (Lotensin)

    • Captopril (trade name Capoten)

    • Cilazapril (Inhibace)

    • Delapril (not available in US)

    • Enalapril (Vasotec/Renitec)

    • Fosinopril (Fositen/Monopril)

    • Imidapril (Tanatril)

    • Lisinopril (Listril/Lopril/Novatec/Prinivil/Zestril)

    • Moexipril (Univasc)

    • Perindopril (Coversyl/Aceon/Perindo)

    • Quinapril (Accupril)

    • Ramipril (Altace/Prilace/Ramace/Ramiwin/Triatec/Tritace)

    • Spirapril (Renormax)

    • Temocapril (not available in US)

    • Teprotide (but not active by oral administration and not used in US)

    • Trandolapril (Mavik/Odrik/Gopten)

    • Zofenopril

    Angiotensin receptor blockers

    • Azilsartan (Edarbi)

    • Candesartan (Atacand)

    • Eprosartan (Teveten)

    • Fimasartan (Kanarb)

    • Irbesartan (Avapro)

    • Losartan (Cozaar)

    • Olmesartan (Benicar/Olmetec)

    • Telmisartan (Micardis)

    • Valsartan (Diovan)

    Aldosterone antagonists

    • Spironolactone (Aldactone)

    • Eplerenone (Inspra)

    Renin inhibitors

    • Aliskiren (Tekturna, Rasilez)

    Other potassium elevating agents

    • Antibiotics, including penicillin G and trimethoprim

    • Azole antifungals

    • Beta-blockers

    • Herbal supplements, including milkweed, lily of the valley, Siberian ginseng, Hawthorn berries

    • Heparin

    • Nonsteroidal anti-inflammatory medications (NSAIDs)

    • Oral contraceptives containing drospirenone

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jacobi Medical Center Bronx New York United States 10461

    Sponsors and Collaborators

    • PhenoSolve, LLC
    • Jacobi Medical Center

    Investigators

    • Principal Investigator: Michael Segal, MD PhD, PhenoSolve, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    PhenoSolve, LLC
    ClinicalTrials.gov Identifier:
    NCT03680885
    Other Study ID Numbers:
    • 2018-271
    First Posted:
    Sep 21, 2018
    Last Update Posted:
    Jul 15, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by PhenoSolve, LLC
    Lidocaine ineffectiveness
    ADHD
    ADD
    Additional relevant MeSH terms:
    Lidocaine

    Study Results

    No Results Posted as of Jul 15, 2020