Experimental Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 Anesthetic Spray in Normal Volunteers

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-07

Study Completion Date

2017-06-07

Brief Summary

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The purpose of this study is to determine if the topical application to cheek tissue of the combination of benzocaine and tetracaine has a longer duration of local anesthetic activity than benzocaine alone.

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Detailed Description

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In a blinded study, either benzocaine alone of the combination of benzocaine and tetracaine will be sprayed onto the cheek mucosal tissue. Onset and duration of local anesthesia will be evaluated over a one hour period using pin prick and QST heat stimulation. Subjects will receive both treatments in a cross-over design with each session separated by 5-7 days. A total of 76 subjects (normal volunteers) will be evaluated.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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One spray CTY-5339-A, then one spray CTY-5339-CB

A single spray of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) tested over a 60 minute session.

Group Type EXPERIMENTAL

One spray CTY-5339-A

Intervention Type COMBINATION_PRODUCT

Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray.

One spray CTY-5339-CB

Intervention Type DRUG

Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray.

2 sprays CTY-5339-A, then 1 spray CTY-5339-CB +1 spray placebo

Two sprays of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) and a single spray of vehicle control (CTY-5339-P) (sprayed outside the circumscribed area to avoid dilution of active drug) tested over a 60 minute session.

Group Type EXPERIMENTAL

Two sprays CTY-5339-A

Intervention Type COMBINATION_PRODUCT

Metered spray bottle with ≈400 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 56 mg total) and 2.0% Tetracaine Hydrochloride (USP = 8 mg total). Administered in two anesthetic sprays.

One spray CTY-5339-CB in combination with one spray CTY-5339-P (vehicle control: placebo)

Intervention Type DRUG

A single spray of CTY-5339-CB in a metered spray bottle with ≈200 uL total spray volume, containing the active ingredient: 14.0% Benzocaine (USP = 28 mg). This was administered in combination with a single spray of CTY-5339-P (acting as vehicle control placebo with no active ingredient) in a metered spray bottle with ≈200 uL total spray volume. This combination was used to maintain double-blind conditions. The vehicle control was sprayed outside the circumscribed area to avoid dilution of active drug.

One spray of CTY-5339-CB, then one spray CTY-5339-A

A single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a single spray of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session.

Group Type EXPERIMENTAL

One spray CTY-5339-A

Intervention Type COMBINATION_PRODUCT

Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray.

One spray CTY-5339-CB

Intervention Type DRUG

Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray.

1 spray CTY-5339-CB +1 spray placebo, then 2 sprays CTY-5339-A

A single spray of CTY-5339-CB Anesthetic Spray (14.0% benzocaine) and a single spray of vehicle control (CTY-5339-P) (sprayed outside the circumscribed area to avoid dilution of active drug) tested over a 60 minute session, followed by a 4-14 day washout period, followed by a two sprays of CTY-5339-A Anesthetic Spray (14.0% benzocaine and 2.0% tetracaine HCl) tested over a 60 minute session.

Group Type EXPERIMENTAL

Two sprays CTY-5339-A

Intervention Type COMBINATION_PRODUCT

Metered spray bottle with ≈400 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 56 mg total) and 2.0% Tetracaine Hydrochloride (USP = 8 mg total). Administered in two anesthetic sprays.

One spray CTY-5339-CB in combination with one spray CTY-5339-P (vehicle control: placebo)

Intervention Type DRUG

A single spray of CTY-5339-CB in a metered spray bottle with ≈200 uL total spray volume, containing the active ingredient: 14.0% Benzocaine (USP = 28 mg). This was administered in combination with a single spray of CTY-5339-P (acting as vehicle control placebo with no active ingredient) in a metered spray bottle with ≈200 uL total spray volume. This combination was used to maintain double-blind conditions. The vehicle control was sprayed outside the circumscribed area to avoid dilution of active drug.

Interventions

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One spray CTY-5339-A

Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray.

Intervention Type COMBINATION_PRODUCT

One spray CTY-5339-CB

Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray.

Intervention Type DRUG

Two sprays CTY-5339-A

Metered spray bottle with ≈400 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 56 mg total) and 2.0% Tetracaine Hydrochloride (USP = 8 mg total). Administered in two anesthetic sprays.

Intervention Type COMBINATION_PRODUCT

One spray CTY-5339-CB in combination with one spray CTY-5339-P (vehicle control: placebo)

A single spray of CTY-5339-CB in a metered spray bottle with ≈200 uL total spray volume, containing the active ingredient: 14.0% Benzocaine (USP = 28 mg). This was administered in combination with a single spray of CTY-5339-P (acting as vehicle control placebo with no active ingredient) in a metered spray bottle with ≈200 uL total spray volume. This combination was used to maintain double-blind conditions. The vehicle control was sprayed outside the circumscribed area to avoid dilution of active drug.

Intervention Type DRUG

Other Intervention Names

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CTY-5339-A CTY-5339 Anesthetic Spray benzocaine tetracaine tetracaine HCl 14.0% benzocaine 2.0% tetracaine HCl 2.0% tetracaine 14.0% benzocaine and 2.0% tetracaine HCl 14.0% benzocaine and 2.0% tetracaine benzocaine and tetracaine HCl benzocaine and tetracaine CTY-5339-CB benzocaine 14.0% benzocaine CTY-5339-A CTY-5339 Anesthetic Spray benzocaine tetracaine tetracaine HCl 14.0% benzocaine 2.0% tetracaine HCl 2.0% tetracaine 14.0% benzocaine and 2.0% tetracaine HCl 14.0% benzocaine and 2.0% tetracaine benzocaine and tetracaine HCl benzocaine and tetracaine CTY-5339-CB and Placebo CTY-5339-CB and Vehicle Control CTY-5339-CB and Control benzocaine benzocaine and Placebo benzocaine and Vehicle Control benzocaine and Control 14.0% benzocaine 14.0% benzocaine and Placebo 14.0% benzocaine and Vehicle Control 14.0% benzocaine and Control

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects between 18-75 years of age with a Body Mass Index (BMI) ≤32;
* Subjects are ASA Category I or II and are in normal physical health as judged by physical and laboratory examinations;
* Subjects with normal appearance of the oral mucosal tissues;
* Subjects must agree to refrain from ingesting any systemic or topical analgesic medication for 3 days or 5 half-lives of the drug prior to and during the study period and alcohol for 1 day prior to and during the study period;
* Subjects must agree to refrain from using mouth rinses, cough drops or throat lozenges on the day of each test session;
* Female subjects must be physically incapable of childbearing potential (postmenopausal for more than 1 year or surgically sterile) or practicing an acceptable method of contraception (hormonal, barrier with spermicide, intrauterine device, vasectomized or same sex partner, or abstinence). Subjects using hormonal birth control must have been on a stable dose of treatment for at least 30 days and received at least 1 cycle of treatment prior to randomization. At Screening and at Baseline of both sessions, all females of childbearing potential must have a negative urine pregnancy test and not be breastfeeding;
* Negative urine drug screen for drugs of abuse at Screening and at Baseline for each Study Session. A positive drug screen result may be permitted if the subject has been on a stable dose of an allowed medication for \>30 days;
* The subject is capable of reading, comprehending, and signing the informed consent form.

Exclusion Criteria

* Subjects with a history of any significant hepatic, renal, endocrine, cardiac, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders, including glaucoma, diabetes, emphysema, and chronic bronchitis;
* Subjects with a history of any type of cancer other than skin related cancers;
* Subjects with conditions that affect the absorption, metabolism, or passage of drugs out of the body, (e.g., sprue, celiac disease, Crohn's disease, colitis, or liver, kidney, or thyroid conditions);
* Subjects with any history of alcohol or substance abuse (including a positive drug screen test);
* Subjects that currently have or have a history of uncontrolled hypertension;
* Subjects with a known hypersensitivity to any local anesthetic drug;
* Subjects with a hematocrit level significantly below the normal range on the screening laboratory examination (as judged by the PI);
* Subjects with any clinically significant abnormal lab result (as judged by the PI);
* Subjects with any condition or history felt by the Investigator to place the subject at increased risk;
* Subjects who have smoked or chewed tobacco-containing substances within 6 months prior to the start of the study;
* Subjects judged by the Investigator to be unable or unwilling to comply with the requirements of the protocol;
* Subjects who have used an investigational drug within 30 days prior to entering the study;
* Subjects who have donated blood within 3 months prior to the start of the study;
* Subjects who have previously participated in the trial;
* Subjects who are members of the study site staff directly involved with the study or a relative of the Sponsor or other personnel involved with the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes