Clinical trial NCT02908620: Experimental Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 Anesthetic Spray in Normal Volunteers
Official title: A Double-blind, Partial Cross-over, Incomplete Factorial Study to Assess the Local Anesthetic Efficacy and Safety of CTY-5339 Anesthetic Spray (CTY-5339-A) When Applied to the Cheek Mucosal Tissue in Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anesthesia
Lead sponsor: Cetylite Industries
Sponsor class: INDUSTRY
First posted: 2016-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
timeFrame: Change in pain assessment from baseline (time of application) up to one hour post-application
measure: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
timeFrame: Change in temperature from baseline (time of application) up to one hour post-application
Secondary outcomes:
measure: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for Two Sprays CTY-5339-A Compared to One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P (Placebo)
timeFrame: Time of application up to one hour post-application
measure: Duration of Anesthesia as Measured by QST Heat for Two Sprays CTY-5339-A Compared to One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P (Placebo)
timeFrame: Time of application up to one hour post-application
measure: Duration of Anesthesia as Measured by PPT for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A
timeFrame: Time of application up to one hour post-application
measure: Duration of Anesthesia as Measured by QST Heat for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A
timeFrame: Time of application up to one hour post-application
measure: Onset of Anesthesia for PPT
timeFrame: Time of application up to one hour post-application
measure: Onset of Anesthesia for QST Heat
timeFrame: Time of application up to one hour post-application
measure: Percentage of Responders for PPT at Each Time Point
timeFrame: Time of application up to one hour post-application
measure: Percentage of Responders for QST Heat at Each Time Point
timeFrame: Time of application up to one hour post-application
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania, School of Dental Medicine Department of Oral & Maxillofacial Surgery
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Elliot V Hersh, DMD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang S, Giannakopoulos H, Lowstetter J, Kaye L, Lee C, Secreto S, Ho V, Hutcheson MC, Farrar JT, Wang P, Doyle G, Cooper SA, Hersh EV. Lack of Methemoglobin Elevations After Topical Applications of Benzocaine Alone or Benzocaine Plus Tetracaine to the Oral Mucosa. Clin Ther. 2017 Oct;39(10):2103-2108. doi: 10.1016/j.clinthera.2017.08.017. Epub 2017 Sep 22.