Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 on Gingival Mucosal Tissue in Normal Volunteers

NCT ID: NCT03233737

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2018-02-20

Brief Summary

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

Detailed Description

In a blinded study, either benzocaine alone or the combination of benzocaine and tetracaine will be sprayed onto the gingival mucosal tissue. Onset and duration of local anesthesia will be evaluated over a one hour period using pin prick and quantitative sensory testing of heat (QST-heat) stimulation. Subjects will receive both treatments in a cross-over design with each session separated by 4-14 days. A total of 50 subjects (normal volunteers) will be evaluated.

Conditions

No Disease State or Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Stage II: 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. Used in Stage II of the study only.

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: DEVICE

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.

Stage II: 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. Used in Stage II of the study only.

Group Type: ACTIVE_COMPARATOR

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: DEVICE

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.

Stage I: 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. Tested over a 60 minute session. Used in Stage I of the study only.

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.

Stage I: 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. Tested over a 60 minute session. Used in Stage I of the study only.

Group Type: ACTIVE_COMPARATOR

One spray CTY-5339-CB

Intervention Type: DEVICE

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.

Stage I: One spray CTY-5339-P

Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (placebo: vehicle control). Administered in a single anesthetic spray. Tested over a 60 minute session. Used in Stage I of the study only.

Group Type: PLACEBO_COMPARATOR

One spray CTY-5339-P

Intervention Type: DEVICE

Placebo. Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (vehicle control).

Interventions

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: DEVICE

One spray CTY-5339-P

Placebo. Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (vehicle control).

Intervention Type: DEVICE

Other Intervention Names

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-P; placebo; vehicle control

Eligibility Criteria

Inclusion Criteria

• Male and female subjects between 18-75 years of age with a Body Mass Index (BMI) ≤32;
• Subjects are category I or II on the American Society of Anesthesiologists physical status classification system (ASA category I or II) and are in normal physical health as judged by physical and laboratory examinations;
• Subjects have normal appearance of the oral mucosal tissues;
• At screening and at Baseline during Stage 1 and Sessions 1 and 2, of Stage 2 subjects with Pin-Prick-Test (PPT) scores of at least "3" (on a 10 point numerical rating scale [NRS]) on the 2 readings, 1 of which must be a score of at least "4";
• Subjects have mean quantitative sensory test of heat (QST-Heat) pain sensation temperature assessments on the gingival mucosa of 46.5 °C or less based on the average of the 2 readings at screening and at the Baseline Study Sessions for Stages 1 and 2;
• 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;
• Subjects must be 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

Sponsors

Cetylite Industries

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen A Cooper, DMD, PhD

Role: STUDY_CHAIR

Locations

University of Pennsylvania, School of Dental Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

References

Hersh EV, Secreto S, Wang S, Giannakopoulos H, Mousavian M, Lesavoy B, Hutcheson MC, Farrar JT, Wang P, Doyle G, Cooper SA. A Proof-of-concept Study Using Quantitative Sensory Threshold Analysis to Compare Two Intraoral Topical Anesthetics. Clin Ther. 2019 Feb;41(2):291-302. doi: 10.1016/j.clinthera.2018.12.009. Epub 2019 Jan 17.

Reference Type: DERIVED

PMID: 30660443 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

C-003

Identifier Type: -

Identifier Source: org_study_id