AnesthesiaPhase 2NCT02908620
Experimental Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 Anesthetic Spray in Normal Volunteers
A Phase 2 study testing One spray CTY-5339-A, One spray CTY-5339-CB and Two sprays CTY-5339-A in people with Anesthesia, run by Cetylite Industries at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- One spray CTY-5339-A, One spray CTY-5339-CB and Two sprays CTY-5339-A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2016to 7 Jun 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, School of Dental Medicine Department of Oral & Maxillofacial Surgery
Philadelphia, Pennsylvania, 19104
About this study
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
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- One spray CTY-5339-A, One spray CTY-5339-CB, Two sprays CTY-5339-A, One spray CTY-5339-CB in combination with one spray CTY-5339-P (vehicle control: placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One spray CTY-5339-ACombination product
Also called CTY-5339-A, CTY-5339 Anesthetic Spray, benzocaine, tetracaine
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-CBDrug
Also called CTY-5339-CB, benzocaine, 14.0% benzocaine
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.
Two sprays CTY-5339-ACombination product
Also called CTY-5339-A, CTY-5339 Anesthetic Spray, benzocaine, tetracaine
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)Drug
Also called CTY-5339-CB and Placebo, CTY-5339-CB and Vehicle Control, CTY-5339-CB and Control, benzocaine
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.
| Study group | Role | What they receive |
|---|---|---|
| One spray CTY-5339-A, then one spray CTY-5339-CB | Experimental | 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. Receives: Combination Product: One spray CTY-5339-A; Drug: One spray CTY-5339-CB |
| 2 sprays CTY-5339-A, then 1 spray CTY-5339-CB +1 spray placebo | Experimental | 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. Receives: Combination Product: Two sprays CTY-5339-A; Drug: One spray CTY-5339-CB in combination with one spray CTY-5339-P (vehicle control: placebo) |
| One spray of CTY-5339-CB, then one spray CTY-5339-A | Experimental | 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. Receives: Combination Product: One spray CTY-5339-A; Drug: One spray CTY-5339-CB |
| 1 spray CTY-5339-CB +1 spray placebo, then 2 sprays CTY-5339-A | Experimental | 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. Receives: Combination Product: Two sprays CTY-5339-A; Drug: One spray CTY-5339-CB in combination with one spray CTY-5339-P (vehicle control: placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
Evaluations were completed at 1-minute intervals for the first 5 minutes to capture onset of anesthesia. Starting at 5 minutes after drug administration, the PPT was done at 5 minute intervals up to the one hour time point. If there was no indication of anesthesia by 10 minutes, the subject was considered a treatment failure and the assessment of PPT was discontinued. In addition, once onset of anesthesia had occurred, if there was no longer any anesthesia at two consecutive evaluation time points from 10 minutes onward, the assessment of PPT was discontinued.
The PPT was assessed using a 90-mm, 26-gauge pencil-point spinal needle. At screening, 3 pin pricks were performed on each cheek. Pin pricks were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale (NRS). In order to be eligible for the study, for each cheek, subjects must have had a minimum score of "3" for the last 2 pin pricks, and one of those scores had to be "4" or higher.
Measured: Change in pain assessment from baseline (time of application) up to one hour post-application
Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
Starting at 5 minutes after drug administration, the QST was done at 5 minute intervals up to the one hour time point. If there was no indication of anesthesia by 10 minutes, the subject was considered a treatment failure and the assessment of PPT was discontinued. In addition, once onset of anesthesia had occurred, if there was no longer any anesthesia at two consecutive evaluation time points from 10 minutes onward, the assessment of QST was discontinued.
The heat stimuli were delivered in 3 repetitions, with inter-stimulus intervals of 30s. The basal thermode temperature was set at a comfortable 35ºC. The rate at which the thermode heated up was set at 0.5ºC/s, while the rate at which it cooled down was set at 8ºC/s. The maximum thermode temperature was set at 51ºC. Heat sensation threshold was defined as the temperature at which the subjects first felt tingling, warmth, heat, or pain.
Measured: Change in temperature from baseline (time of application) up to one hour post-application
Secondary outcomes (8)
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)
Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that. Duration of effect was defined as the time (in minutes) from onset to treatment failure (i.e., for PPT, an assessment of "Same/More" pain, and for QST, the average heat temperature was greater than the average heat temperature at Baseline (non-treated cheek), up to the 60-minute time point (at two consecutive time points).
Measured: Time of application up to one hour post-application
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)
Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that. Duration of effect was defined as the time (in minutes) from onset to treatment failure (i.e., for PPT, an assessment of "Same/More" pain, and for QST, the average heat temperature was greater than the average heat temperature at Baseline (non-treated cheek), up to the 60-minute time point (at two consecutive time points).
Measured: Time of application up to one hour post-application
Duration of Anesthesia as Measured by PPT for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A
Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that.
Measured: Time of application up to one hour post-application
Duration of Anesthesia as Measured by QST Heat for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A
Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that.
Measured: Time of application up to one hour post-application
Onset of Anesthesia for PPT
Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that.
Measured: Time of application up to one hour post-application
Onset of Anesthesia for QST Heat
Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that.
Measured: Time of application up to one hour post-application
Percentage of Responders for PPT at Each Time Point
Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that.
Measured: Time of application up to one hour post-application
Percentage of Responders for QST Heat at Each Time Point
Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that.
Measured: Time of application up to one hour post-application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start7 Dec 2016
- Primary completion2 Apr 2017
- Study completion7 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cetylite Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elliot V Hersh, DMD, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908620
- Sponsor's protocol ID
- C-002
- Status last verified
- Jun 2019
- First submitted
- 2 Sep 2016
- Last updated
- 2 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28943117
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02908620
- Acronym / sponsor ID
- C-002
- Conditions
- Anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cetylite IndustriesIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2016 (actual)
- Primary completion
- 2 Apr 2017 (actual)
- Study completion
- 7 Jun 2017 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Posted 2 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| One spray CTY-5339-A, then one spray CTY-5339-CB | Experimental | Combination Product: One spray CTY-5339-A, Drug: One spray CTY-5339-CBA 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. |
| 2 sprays CTY-5339-A, then 1 spray CTY-5339-CB +1 spray placebo | Experimental | Combination Product: Two sprays CTY-5339-A, Drug: One spray CTY-5339-CB in combination with one spray CTY-5339-P (vehicle control: 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. |
| One spray of CTY-5339-CB, then one spray CTY-5339-A | Experimental | Combination Product: One spray CTY-5339-A, Drug: One spray CTY-5339-CBA 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. |
| 1 spray CTY-5339-CB +1 spray placebo, then 2 sprays CTY-5339-A | Experimental | Combination Product: Two sprays CTY-5339-A, Drug: One spray CTY-5339-CB in combination with one spray CTY-5339-P (vehicle control: placebo)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One spray CTY-5339-AAlso: CTY-5339-A, CTY-5339 Anesthetic Spray, benzocaine, tetracaineMetered 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. | Combination product | One spray CTY-5339-A, then one spray CTY-5339-CB, One spray of CTY-5339-CB, then one spray CTY-5339-A |
| One spray CTY-5339-CBAlso: CTY-5339-CB, benzocaine, 14.0% benzocaineMetered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray. | Drug | One spray CTY-5339-A, then one spray CTY-5339-CB, One spray of CTY-5339-CB, then one spray CTY-5339-A |
| Two sprays CTY-5339-AAlso: CTY-5339-A, CTY-5339 Anesthetic Spray, benzocaine, tetracaineMetered 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. | Combination product | 1 spray CTY-5339-CB +1 spray placebo, then 2 sprays CTY-5339-A, 2 sprays CTY-5339-A, then 1 spray CTY-5339-CB +1 spray placebo |
| One spray CTY-5339-CB in combination with one spray CTY-5339-P (vehicle control: placebo)Also: CTY-5339-CB and Placebo, CTY-5339-CB and Vehicle Control, CTY-5339-CB and Control, benzocaineA 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. | Drug | 1 spray CTY-5339-CB +1 spray placebo, then 2 sprays CTY-5339-A, 2 sprays CTY-5339-A, then 1 spray CTY-5339-CB +1 spray placebo |
Primary outcome
Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
Time frame: Change in pain assessment from baseline (time of application) up to one hour post-application
Evaluations were completed at 1-minute intervals for the first 5 minutes to capture onset of anesthesia. Starting at 5 minutes after drug administration, the PPT was done at 5 minute intervals up to the one hour time point. If there was no indication of anesthesia by 10 minutes, the subject was considered a treatment failure and the assessment of PPT was discontinued. In addition, once onset of anesthesia had occurred, if there was no longer any anesthesia at two consecutive evaluation time points from 10 minutes onward, the assessment of PPT was discontinued. The PPT was assessed using a 90-mm, 26-gauge pencil-point spinal needle. At screening, 3 pin pricks were performed on each cheek. Pin pricks were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale (NRS). In order to be eligible for the study, for each cheek, subjects must have had a minimum score of "3" for the last 2 pin pricks, and one of those scores had to be "4" or higher.
Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
Time frame: Change in temperature from baseline (time of application) up to one hour post-application
Starting at 5 minutes after drug administration, the QST was done at 5 minute intervals up to the one hour time point. If there was no indication of anesthesia by 10 minutes, the subject was considered a treatment failure and the assessment of PPT was discontinued. In addition, once onset of anesthesia had occurred, if there was no longer any anesthesia at two consecutive evaluation time points from 10 minutes onward, the assessment of QST was discontinued. The heat stimuli were delivered in 3 repetitions, with inter-stimulus intervals of 30s. The basal thermode temperature was set at a comfortable 35ºC. The rate at which the thermode heated up was set at 0.5ºC/s, while the rate at which it cooled down was set at 8ºC/s. The maximum thermode temperature was set at 51ºC. Heat sensation threshold was defined as the temperature at which the subjects first felt tingling, warmth, heat, or pain.
8 secondary outcomes
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)
Time frame: Time of application up to one hour post-application
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)
Time frame: Time of application up to one hour post-application
Duration of Anesthesia as Measured by PPT for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A
Time frame: Time of application up to one hour post-application
Duration of Anesthesia as Measured by QST Heat for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A
Time frame: Time of application up to one hour post-application
Onset of Anesthesia for PPT
Time frame: Time of application up to one hour post-application
Onset of Anesthesia for QST Heat
Time frame: Time of application up to one hour post-application
Percentage of Responders for PPT at Each Time Point
Time frame: Time of application up to one hour post-application
Percentage of Responders for QST Heat at Each Time Point
Time frame: Time of application up to one hour post-application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28943117Wang 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.
- Individual participant dataSharing planned: No
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Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliot V Hersh, DMD, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing One spray CTY-5339-A, One spray CTY-5339-CB and Two sprays CTY-5339-A in people with Anesthesia, run by Cetylite Industries at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB (time frame: Change in pain assessment from baseline (time of application) up to one hour post-application). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02908620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.