Overview

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

Status:
Completed
Trial end date:
2018-02-20
Target enrollment:
50
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Cetylite Industries
Treatments:
Anesthetics
Anesthetics, Local
Benzocaine
Tetracaine
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;

- At screening and at Baseline during Stage 1 and Sessions 1 and 2, of Stage 2 subjects
with PPT scores of at least "3" (on a 10 point NRS) on the 2 readings, 1 of which must
be a score of at least "4";

- Subjects with mean QST Heat Pain sensation temperature assessments on the gingival
mucosa of 46.5oC 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;

- 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.