Trial Outcomes & Findings for Experimental Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 Anesthetic Spray in Normal Volunteers (NCT NCT02908620)
NCT ID: NCT02908620
Last Updated: 2019-07-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Change in pain assessment from baseline (time of application) up to one hour post-application
Results posted on
2019-07-02
Participant Flow
Study conducted at the University of Pennsylvania School of Dental Medicine. 240 South 40th Street, Robert Schattner Center, Philadelphia, PA 19104. Recruitment was from normal volunteers.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Experimental Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 Anesthetic Spray in Normal Volunteers
Baseline characteristics by cohort
| Measure |
One Spray CTY-5339-A, Then One Spray CTY-5339-CB
n=10 Participants
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.
|
2 Sprays CTY-5339-A, Then 1 Spray CTY-5339-CB +1 Spray Placebo
n=10 Participants
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
n=10 Participants
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.
|
1 Spray CTY-5339-CB +1 Spray Placebo, Then 2 Sprays CTY-5339-A
n=10 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
28.6 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
25.0 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
26.4 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
27.6 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
26.9 years
STANDARD_DEVIATION 5.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
40 participants
n=21 Participants
|
|
Weight (lbs)
|
163.6 lbs
STANDARD_DEVIATION 38.3 • n=5 Participants
|
153.6 lbs
STANDARD_DEVIATION 31.8 • n=7 Participants
|
151.4 lbs
STANDARD_DEVIATION 33.7 • n=5 Participants
|
144.5 lbs
STANDARD_DEVIATION 18.0 • n=4 Participants
|
153.3 lbs
STANDARD_DEVIATION 30.9 • n=21 Participants
|
|
Height (inches)
|
66.7 inches
STANDARD_DEVIATION 3.4 • n=5 Participants
|
67.1 inches
STANDARD_DEVIATION 2.6 • n=7 Participants
|
68.3 inches
STANDARD_DEVIATION 2.3 • n=5 Participants
|
67.0 inches
STANDARD_DEVIATION 2.9 • n=4 Participants
|
67.3 inches
STANDARD_DEVIATION 2.8 • n=21 Participants
|
PRIMARY outcome
Timeframe: Change in pain assessment from baseline (time of application) up to one hour post-applicationPopulation: Modified Intent-to-Treat (mITT) population: all randomized subjects who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) either completed the two 60 minute test sessions or returned to baseline values in all evaluation tests.
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.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=18 Participants
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
n=18 Participants
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.
|
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.
|
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P
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.
|
|---|---|---|---|---|
|
Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
|
17.9 minutes
Standard Deviation 12.9
|
16.4 minutes
Standard Deviation 14.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Change in temperature from baseline (time of application) up to one hour post-applicationPopulation: Modified Intent-to-Treat (mITT) population: all randomized subjects who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) either completed the two 60 minute test sessions or returned to baseline values in all evaluation tests.
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.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=19 Participants
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
n=18 Participants
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.
|
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.
|
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P
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.
|
|---|---|---|---|---|
|
Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
|
44.6 minutes
Standard Deviation 17.8
|
51.1 minutes
Standard Deviation 12.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Time of application up to one hour post-applicationPopulation: Modified Intent-to-Treat (mITT) population: all randomized subjects who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) either completed the two 60 minute test sessions or returned to baseline values in all evaluation tests.
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).
Outcome measures
| Measure |
One Spray CTY-5339-A
n=18 Participants
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
n=17 Participants
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.
|
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.
|
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P
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.
|
|---|---|---|---|---|
|
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)
|
17.3 Minutes
Standard Deviation 17.0
|
13.5 Minutes
Standard Deviation 14.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Time of application up to one hour post-applicationPopulation: Modified Intent-to-Treat (mITT) population: all randomized subjects who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) either completed the two 60 minute test sessions or returned to baseline values in all evaluation tests.
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).
Outcome measures
| Measure |
One Spray CTY-5339-A
n=19 Participants
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
n=20 Participants
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.
|
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.
|
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P
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.
|
|---|---|---|---|---|
|
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)
|
46.8 minutes
Standard Deviation 17.3
|
38.9 minutes
Standard Deviation 20.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Time of application up to one hour post-applicationAssessments 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.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=18 Participants
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
n=18 Participants
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.
|
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.
|
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P
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.
|
|---|---|---|---|---|
|
Duration of Anesthesia as Measured by PPT for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A
|
17.9 minutes
Standard Deviation 12.9
|
17.3 minutes
Standard Deviation 17.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Time of application up to one hour post-applicationAssessments 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.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=19 Participants
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
n=19 Participants
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.
|
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.
|
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P
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.
|
|---|---|---|---|---|
|
Duration of Anesthesia as Measured by QST Heat for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A
|
44.6 minutes
Standard Deviation 17.8
|
46.8 minutes
Standard Deviation 17.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Time of application up to one hour post-applicationPopulation: Modified Intent-to-Treat (mITT) population: all randomized subjects who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) either completed the two 60 minute test sessions or returned to baseline values in all evaluation tests.
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.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=18 Participants
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
n=18 Participants
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.
|
One Spray CTY-5339-CB
n=18 Participants
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.
|
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P
n=17 Participants
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.
|
|---|---|---|---|---|
|
Onset of Anesthesia for PPT
|
1.2 Minutes
Standard Deviation 0.4
|
1.5 Minutes
Standard Deviation 0.9
|
1.7 Minutes
Standard Deviation 2.1
|
1.7 Minutes
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Time of application up to one hour post-applicationPopulation: Modified Intent-to-Treat (mITT) population: all randomized subjects who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) either completed the two 60 minute test sessions or returned to baseline values in all evaluation tests.
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.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=19 Participants
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
n=19 Participants
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.
|
One Spray CTY-5339-CB
n=18 Participants
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.
|
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P
n=20 Participants
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.
|
|---|---|---|---|---|
|
Onset of Anesthesia for QST Heat
|
3.1 Minutes
Standard Deviation 3.3
|
1.9 Minutes
Standard Deviation 1.4
|
1.7 Minutes
Standard Deviation 1.3
|
4.2 Minutes
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Time of application up to one hour post-applicationPopulation: Some treatment response data was missing or lost or an invalid value was recorded
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.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=20 Participants
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
n=20 Participants
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.
|
One Spray CTY-5339-CB
n=20 Participants
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.
|
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P
n=20 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 50 minute time point
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 55 minute time point
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 60 minute time point
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 1 minute time point
|
12 Participants
|
12 Participants
|
14 Participants
|
10 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 2 minute time point
|
13 Participants
|
9 Participants
|
14 Participants
|
13 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 3 minute time point
|
12 Participants
|
11 Participants
|
12 Participants
|
10 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 4 minute time point
|
12 Participants
|
12 Participants
|
8 Participants
|
8 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 5 minute time point
|
10 Participants
|
7 Participants
|
7 Participants
|
9 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 10 minute time point
|
5 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 15 minute time point
|
8 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 20 minute time point
|
4 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 25 minute time point
|
3 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 30 minute time point
|
3 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 35 minute time point
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 40 minute time point
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Percentage of Responders for PPT at Each Time Point
Responded to treatment at the 45 minute time point
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Time of application up to one hour post-applicationPopulation: A baseline measure was lost/missing for one treatment so the response could not be calculated.
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.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=20 Participants
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
n=19 Participants
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.
|
One Spray CTY-5339-CB
n=20 Participants
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.
|
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P
n=20 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Responders for QST Heat at Each Time Point
Responded to treatment at the 10 minute time point
|
17 Participants
|
17 Participants
|
17 Participants
|
13 Participants
|
|
Percentage of Responders for QST Heat at Each Time Point
Responded to treatment at the 15 minute time point
|
15 Participants
|
17 Participants
|
18 Participants
|
15 Participants
|
|
Percentage of Responders for QST Heat at Each Time Point
Responded to treatment at the 20 minute time point
|
17 Participants
|
15 Participants
|
17 Participants
|
14 Participants
|
|
Percentage of Responders for QST Heat at Each Time Point
Responded to treatment at the 25 minute time point
|
15 Participants
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Percentage of Responders for QST Heat at Each Time Point
Responded to treatment at the 30 minute time point
|
14 Participants
|
14 Participants
|
14 Participants
|
13 Participants
|
|
Percentage of Responders for QST Heat at Each Time Point
Responded to treatment at the 35 minute time point
|
13 Participants
|
12 Participants
|
17 Participants
|
12 Participants
|
|
Percentage of Responders for QST Heat at Each Time Point
Responded to treatment at the 40 minute time point
|
12 Participants
|
11 Participants
|
16 Participants
|
12 Participants
|
|
Percentage of Responders for QST Heat at Each Time Point
Responded to treatment at the 45 minute time point
|
13 Participants
|
11 Participants
|
12 Participants
|
11 Participants
|
|
Percentage of Responders for QST Heat at Each Time Point
Responded to treatment at the 50 minute time point
|
9 Participants
|
12 Participants
|
10 Participants
|
10 Participants
|
|
Percentage of Responders for QST Heat at Each Time Point
Responded to treatment at the 55 minute time point
|
9 Participants
|
11 Participants
|
9 Participants
|
9 Participants
|
|
Percentage of Responders for QST Heat at Each Time Point
Responded to treatment at the 60 minute time point
|
10 Participants
|
11 Participants
|
10 Participants
|
8 Participants
|
|
Percentage of Responders for QST Heat at Each Time Point
Responded to treatment at the 5 minute time point
|
16 Participants
|
18 Participants
|
18 Participants
|
15 Participants
|
Adverse Events
CTY-5339-A 1 Spray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CTY-5339-A 2 Sprays
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CTY-5339-CB 1 Spray
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CTY-5339-CB 1 Spray + Placebo 1 Spray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CTY-5339-A 1 Spray
n=20 participants at risk
Benzocaine and Tetracaine 14.0% Benzocaine, USP = 28 mg 2.0% Tetracaine Hydrochloride, USP = 4 mg
Benzocaine and Tetracaine: A single application 1 spray of a combination of benzocaine 14% and tetracaine 2% with a total dose of benzocaine 28 mg and tetracaine 2 mg per spray.
|
CTY-5339-A 2 Sprays
n=20 participants at risk
Benzocaine and Tetracaine 14.0% Benzocaine, USP = 56 mg 2.0% Tetracaine Hydrochloride, USP = 8 mg
Benzocaine and Tetracaine: A single application of 2 sprays of a combination of benzocaine 14% and tetracaine 2% with a total dose of benzocaine 28 mg and tetracaine 2 mg per spray.
|
CTY-5339-CB 1 Spray
n=20 participants at risk
Benzocaine only 14.0% Benzocaine, USP = 28 mg
Benzocaine only: Benzocaine 14% alone 200 uL (1 spray)
A single application of 1 spray of benzocaine 14% with a total dose of benzocaine 28 mg.
|
CTY-5339-CB 1 Spray + Placebo 1 Spray
n=20 participants at risk
Benzocaine and Placebo 14.0% Benzocaine, USP = 28 mg; 200 uL and one spray Vehicle control (no active ingredient); 200 uL
A single application of 1 spray of benzocaine 14% and a single spray of placebo with a total dose of benzocaine 28 mg.
|
|---|---|---|---|---|
|
Nervous system disorders
Feeling faint
|
0.00%
0/20 • Adverse event data collected during and for one hour post testing.
|
0.00%
0/20 • Adverse event data collected during and for one hour post testing.
|
5.0%
1/20 • Number of events 1 • Adverse event data collected during and for one hour post testing.
|
0.00%
0/20 • Adverse event data collected during and for one hour post testing.
|
Additional Information
Elliot V Hersh, DMD, Ph.D., Director Clinical Pharmacology Research
University of Pennsylvania, School of Dental Medicine
Phone: 215-898-9686
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place