Trial Outcomes & Findings for Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 on Gingival Mucosal Tissue in Normal Volunteers (NCT NCT03233737)
NCT ID: NCT03233737
Last Updated: 2019-08-21
Results Overview
The duration of effect, was defined as the length of time in minutes from onset of anesthesia to the absence of anesthesia.Onset was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than Baseline. Absence of anesthesia was defined as follows: After Onset had been established, absence was the first of two time points with consecutive occurrences of regression of absence of analgesia. Reports of less pain by ≥1 unit than Baseline indicated analgesia; while a report of similar (\< 1 unit) or more pain than Baseline indicated regression or absence of analgesia. The minimum onset time was 1 minute. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
COMPLETED
PHASE2
75 participants
Up to one hour post-application
2019-08-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
5
|
24
|
26
|
|
Overall Study
COMPLETED
|
10
|
10
|
5
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 on Gingival Mucosal Tissue in Normal Volunteers
Baseline characteristics by cohort
| Measure |
Stage II: One Spray CTY-5339-A, Then One Spray CTY-5339-CB
n=24 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. Used in Stage II of the study only.
|
Stage II: One Spray of CTY-5339-CB, Then One Spray CTY-5339-A
n=26 Participants
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.
|
Stage I: One Spray CTY-5339-A
n=10 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. Tested over a 60 minute session. Used in Stage I of the study only.
|
Stage I: One Spray CTY-5339-CB
n=10 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. Tested over a 60 minute session. Used in Stage I of the study only.
|
Stage I: One Spray CTY-5339-P
n=5 Participants
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.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
24.3 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
23.5 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
28.1 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
27.6 years
STANDARD_DEVIATION 2.5 • n=4 Participants
|
26.2 years
STANDARD_DEVIATION 2.4 • n=21 Participants
|
25.1 years
STANDARD_DEVIATION 3.9 • n=10 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
67 Participants
n=10 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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
30 Participants
n=10 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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
38 Participants
n=10 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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
5 participants
n=21 Participants
|
75 participants
n=10 Participants
|
|
Weight (lbs)
|
154.1 lbs
STANDARD_DEVIATION 33.0 • n=5 Participants
|
141.2 lbs
STANDARD_DEVIATION 27.6 • n=7 Participants
|
151.6 lbs
STANDARD_DEVIATION 31.0 • n=5 Participants
|
128.1 lbs
STANDARD_DEVIATION 22.5 • n=4 Participants
|
166.0 lbs
STANDARD_DEVIATION 35.4 • n=21 Participants
|
146.6 lbs
STANDARD_DEVIATION 29.9 • n=10 Participants
|
|
Height (inches)
|
67.3 inches
STANDARD_DEVIATION 4.1 • n=5 Participants
|
65.8 inches
STANDARD_DEVIATION 2.6 • n=7 Participants
|
66.9 inches
STANDARD_DEVIATION 4.2 • n=5 Participants
|
65.1 inches
STANDARD_DEVIATION 1.9 • n=4 Participants
|
67.2 inches
STANDARD_DEVIATION 2.3 • n=21 Participants
|
66.4 inches
STANDARD_DEVIATION 3.3 • n=10 Participants
|
PRIMARY outcome
Timeframe: Up to one hour post-applicationThe duration of effect, was defined as the length of time in minutes from onset of anesthesia to the absence of anesthesia.Onset was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than Baseline. Absence of anesthesia was defined as follows: After Onset had been established, absence was the first of two time points with consecutive occurrences of regression of absence of analgesia. Reports of less pain by ≥1 unit than Baseline indicated analgesia; while a report of similar (\< 1 unit) or more pain than Baseline indicated regression or absence of analgesia. The minimum onset time was 1 minute. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=50 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=50 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. Tested over a 60 minute session.
|
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.
|
|---|---|---|---|
|
Stage II: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
|
14.6 minutes
Standard Deviation 16.1
|
7.4 minutes
Standard Deviation 11.1
|
—
|
PRIMARY outcome
Timeframe: Up to one hour post-applicationThe duration of effect, was defined as the time from onset to treatment failure, as measured by QST Heat score. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The QST Heat-based "Duration of effect" was calculated by the length of time in minutes from onset of anesthesia to the absence of anesthesia where Onset of anesthesia was defined by PPT unless specific QST thresholds were not met. After Onset had been established, absence of analgesia or offset was the first of two time points with consecutive occurrences of regression or absence of analgesia. Reports of QST heat pain temperature by ≥ 3 °C of the Baseline QST indicated analgesia; while a report of similar (\<3 °C) than Baseline indicated regression or absence of analgesia. Stage
Outcome measures
| Measure |
One Spray CTY-5339-A
n=50 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=50 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. Tested over a 60 minute session.
|
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.
|
|---|---|---|---|
|
Stage II: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
|
45.5 minutes
Standard Deviation 13.6
|
40.8 minutes
Standard Deviation 16.3
|
—
|
PRIMARY outcome
Timeframe: Up to one hour post-applicationPopulation: Placebo duration of effect was not analyzed.
The duration of effect, was defined as the length of time in minutes from onset of anesthesia to the absence of anesthesia.Onset was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than Baseline. Absence of anesthesia was defined as follows: After Onset had been established, absence was the first of two time points with consecutive occurrences of regression of absence of analgesia. Reports of less pain by ≥1 unit than Baseline indicated analgesia; while a report of similar (\< 1 unit) or more pain than Baseline indicated regression or absence of analgesia. The minimum onset time was 1 minute. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=10 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=10 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. Tested over a 60 minute session.
|
Stage I: One Spray CTY-5339-P
n=5 Participants
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.
|
|---|---|---|---|
|
Stage I: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control)
|
49.2 minutes
Standard Deviation 14.34
|
21.3 minutes
Standard Deviation 15.47
|
25.2 minutes
Standard Deviation 30.9
|
PRIMARY outcome
Timeframe: Up to one hour post-applicationThe duration of effect, was defined as the time from onset to treatment failure, as measured by QST Heat score. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The QST Heat-based "Duration of effect" was calculated by the length of time in minutes from onset of anesthesia to the absence of anesthesia where Onset of anesthesia was defined by PPT unless specific QST thresholds were not met. After Onset had been established, absence of analgesia or offset was the first of two time points with consecutive occurrences of regression or absence of analgesia. Reports of QST heat pain temperature by ≥ 3 °C of the Baseline QST indicated analgesia; while a report of similar (\<3 °C) than Baseline indicated regression or absence of analgesia. Stage I outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=10 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=10 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. Tested over a 60 minute session.
|
Stage I: One Spray CTY-5339-P
n=5 Participants
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.
|
|---|---|---|---|
|
Stage I: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control)
|
42.5 minutes
Standard Deviation 21.10
|
6.1 minutes
Standard Deviation 11.49
|
5 minutes
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Up to one hour post-applicationOnset of anesthesia was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than the Baseline PPT. Onset was expected to be between 1 and 5 minutes. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=50 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=50 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. Tested over a 60 minute session.
|
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.
|
|---|---|---|---|
|
Stage II: Onset of Anesthesia for Pin Prick Test (PPT)
|
1.1 minutes
Standard Deviation 0.2
|
1.1 minutes
Standard Deviation 0.6
|
—
|
SECONDARY outcome
Timeframe: Up to one hour post-applicationOnset of anesthesia was defined by Pin Prick Test (PPT) unless specific QST thresholds were not met. * If the PPT Onset was 5 minutes or less, then QST must have been greater than the Baseline QST temperature at 5 minutes by any amount and QST must have been ≥ 3 °C of the Baseline QST at 5 or 10 minutes. * If the PPT Onset was 10 minutes, then QST must have been ≥ 3 °C of the Baseline QST temperature at 10 minutes. * If PPT did not achieve Onset, then QST alone could have achieved onset at either 5 or 10 minutes if QST was greater than the Baseline QST temperature at 5 or 10 minutes by any amount and the QST was ≥ 3 °C of the Baseline QST at 5 or 10 minutes. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=50 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=50 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. Tested over a 60 minute session.
|
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.
|
|---|---|---|---|
|
Stage II: Onset of Anesthesia for Heat Sensation Threshold (QST Heat)
|
1 minutes
Standard Deviation 1.4
|
1.3 minutes
Standard Deviation 2.4
|
—
|
SECONDARY outcome
Timeframe: Up to one hour post-applicationResponse at at time point is defined as when the PPT average pain score was less than the Baseline PPT average score by any amount. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=50 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=50 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. Tested over a 60 minute session.
|
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.
|
|---|---|---|---|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 4 minute time point
|
49 Participants
|
48 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 35 minute time point
|
43 Participants
|
34 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 40 minute time point
|
36 Participants
|
27 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 60 minute time point
|
19 Participants
|
18 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 1 minute time point
|
47 Participants
|
46 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 2 minute time point
|
50 Participants
|
48 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 3 minute time point
|
50 Participants
|
48 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 5 minute time point
|
49 Participants
|
49 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 10 minute time point
|
49 Participants
|
49 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 15 minute time point
|
49 Participants
|
48 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 20 minute time point
|
49 Participants
|
46 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 25 minute time point
|
48 Participants
|
45 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 30 minute time point
|
46 Participants
|
42 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 45 minute time point
|
32 Participants
|
21 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 50 minute time point
|
25 Participants
|
20 Participants
|
—
|
|
Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 55 minute time point
|
20 Participants
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to one hour post-applicationResponse at a time point is defined as an increase of QST heat pain temperature by ≥ 3 degrees C compared to the Baseline QST. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=50 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=50 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. Tested over a 60 minute session.
|
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.
|
|---|---|---|---|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 1 minute time point
|
36 Participants
|
29 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 4 minute time point
|
37 Participants
|
30 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 25 minute time point
|
32 Participants
|
24 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 2 minute time point
|
37 Participants
|
30 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 3 minute time point
|
37 Participants
|
30 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 5 minute time point
|
37 Participants
|
31 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 10 minute time point
|
38 Participants
|
34 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 15 minute time point
|
38 Participants
|
31 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 20 minute time point
|
36 Participants
|
29 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 30 minute time point
|
28 Participants
|
19 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 35 minute time point
|
24 Participants
|
15 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 40 minute time point
|
22 Participants
|
15 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 45 minute time point
|
19 Participants
|
12 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 50 minute time point
|
17 Participants
|
12 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 55 minute time point
|
14 Participants
|
11 Participants
|
—
|
|
Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 60 minute time point
|
13 Participants
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Any time within one hour post-applicationResponse is defined as a subject having a PPT average pain score of ≤2 recorded at any single time point where PPT was performed. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=50 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=50 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. Tested over a 60 minute session.
|
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.
|
|---|---|---|---|
|
Stage II: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)
|
50 Participants
|
50 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to one hour post-applicationResponse at a time point is defined as having the PPT average pain score of ≤2. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage II outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=50 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=50 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. Tested over a 60 minute session.
|
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.
|
|---|---|---|---|
|
Stage II: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)
|
14.6 minutes
Standard Deviation 16.1
|
7.4 minutes
Standard Deviation 11.1
|
—
|
SECONDARY outcome
Timeframe: Any time within one hour post-applicationQST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Reaching maximum heat for QST Heat was defined as subjects reaching the maximum temperature without reporting pain at one or more time points. Stage II outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=50 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=50 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. Tested over a 60 minute session.
|
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.
|
|---|---|---|---|
|
Stage II: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat)
|
7 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to one hour post-applicationSPID was calculated as a sum of the delta PPT scores at each time point until the designated time point. The delta PPT score is defined as the change in PPT score from baseline. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The total possible scale range was from -100 (best) to +100 (worst) for SPID at the 30 minute time point, and from -160 (best) to +160 (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective). Stage II outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=50 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=50 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. Tested over a 60 minute session.
|
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.
|
|---|---|---|---|
|
Stage II: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc)
SPID at the 30 minute time point
|
-85.2 score
Standard Deviation 35.9
|
-63.2 score
Standard Deviation 29.38
|
—
|
|
Stage II: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc)
SPID at the 60 minute time point
|
-122.6 score
Standard Deviation 63.52
|
-86.6 score
Standard Deviation 53.15
|
—
|
SECONDARY outcome
Timeframe: Up to one hour post-applicationSTID was calculated as a sum of the delta QST Heat scores at each time point until the designated time point. The delta QST Heat score is defined as the change in QST Heat score from baseline. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The total possible scale range was from -155 ºC (best) to +155 ºC (worst) for STID at the 30 minute time point, and from -248 ºC (best) to +248 ºC (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective). Stage II outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=50 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=50 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. Tested over a 60 minute session.
|
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.
|
|---|---|---|---|
|
Stage II: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc)
STID at the 30 minute time point
|
136.5 Degrees Celcius (ºC)
Standard Deviation 67.78
|
96.6 Degrees Celcius (ºC)
Standard Deviation 72.63
|
—
|
|
Stage II: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc)
STID at the 60 minute time point
|
214 Degrees Celcius (ºC)
Standard Deviation 140.10
|
149.1 Degrees Celcius (ºC)
Standard Deviation 142.36
|
—
|
SECONDARY outcome
Timeframe: Time of application up to one hour post-applicationResponse at at time point is defined as when the PPT average pain score was less than the Baseline PPT average score by any amount. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=10 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=10 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. Tested over a 60 minute session.
|
Stage I: One Spray CTY-5339-P
n=5 Participants
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.
|
|---|---|---|---|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 1 minute time point
|
8 Participants
|
8 Participants
|
4 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 3 minute time point
|
10 Participants
|
10 Participants
|
3 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 4 minute time point
|
10 Participants
|
10 Participants
|
3 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 20 minute time point
|
10 Participants
|
4 Participants
|
2 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 30 minute time point
|
9 Participants
|
2 Participants
|
2 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 50 minute time point
|
7 Participants
|
1 Participants
|
2 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 55 minute time point
|
6 Participants
|
1 Participants
|
2 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 60 minute time point
|
6 Participants
|
1 Participants
|
2 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 2 minute time point
|
9 Participants
|
10 Participants
|
3 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 5 minute time point
|
10 Participants
|
10 Participants
|
2 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 10 minute time point
|
10 Participants
|
10 Participants
|
3 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 15 minute time point
|
10 Participants
|
8 Participants
|
3 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 25 minute time point
|
9 Participants
|
4 Participants
|
2 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 35 minute time point
|
9 Participants
|
2 Participants
|
2 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 40 minute time point
|
8 Participants
|
1 Participants
|
2 Participants
|
|
Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
Responded to treatment at the 45 minute time point
|
7 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Time of application up to one hour post-applicationResponse at a time point is defined as an increase of QST heat pain temperature by ≥ 3 degrees C compared to the Baseline QST. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=10 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=10 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. Tested over a 60 minute session.
|
Stage I: One Spray CTY-5339-P
n=5 Participants
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.
|
|---|---|---|---|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 1 minute time point
|
7 Participants
|
2 Participants
|
4 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 3 minute time point
|
8 Participants
|
3 Participants
|
4 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 4 minute time point
|
8 Participants
|
3 Participants
|
4 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 10 minute time point
|
9 Participants
|
3 Participants
|
4 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 30 minute time point
|
8 Participants
|
1 Participants
|
0 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 35 minute time point
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 40 minute time point
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 45 minute time point
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 50 minute time point
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 55 minute time point
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 20 minute time point
|
9 Participants
|
2 Participants
|
4 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 25 minute time point
|
9 Participants
|
1 Participants
|
1 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 60 minute time point
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 2 minute time point
|
7 Participants
|
3 Participants
|
4 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 5 minute time point
|
8 Participants
|
3 Participants
|
4 Participants
|
|
Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
Responded to treatment at the 15 minute time point
|
9 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to one hour post-applicationResponse at a time point is defined as having the PPT average pain score of ≤2. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=10 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=10 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. Tested over a 60 minute session.
|
Stage I: One Spray CTY-5339-P
n=5 Participants
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.
|
|---|---|---|---|
|
Stage I: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)
|
14.5 minutes
Standard Deviation 11.7
|
2.9 minutes
Standard Deviation 3.3
|
0.2 minutes
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Any time within one hour post-applicationQST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Reaching maximum heat for QST Heat was defined as subjects reaching the maximum temperature without reporting pain at one or more time points. Stage I outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=10 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=10 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. Tested over a 60 minute session.
|
Stage I: One Spray CTY-5339-P
n=5 Participants
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.
|
|---|---|---|---|
|
Stage I: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat)
|
5 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to one hour post-applicationOnset of anesthesia was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than the Baseline PPT. Onset was expected to be between 1 and 5 minutes. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=10 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=10 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. Tested over a 60 minute session.
|
Stage I: One Spray CTY-5339-P
n=5 Participants
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.
|
|---|---|---|---|
|
Stage I: Onset of Anesthesia for Pin Prick Test (PPT)
|
1.3 minutes
Standard Deviation 0.7
|
1.2 minutes
Standard Deviation 0.4
|
2.8 minutes
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Up to one hour post-applicationOnset of anesthesia was defined by Pin Prick Test (PPT) unless specific QST thresholds were not met. * If the PPT Onset was 5 minutes or less, then QST must have been greater than the Baseline QST temperature at 5 minutes by any amount and QST must have been ≥ 3 °C of the Baseline QST at 5 or 10 minutes. * If the PPT Onset was 10 minutes, then QST must have been ≥ 3 °C of the Baseline QST temperature at 10 minutes. * If PPT did not achieve Onset, then QST alone could have achieved onset at either 5 or 10 minutes if QST was greater than the Baseline QST temperature at 5 or 10 minutes by any amount and the QST was ≥ 3 °C of the Baseline QST at 5 or 10 minutes. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=10 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=10 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. Tested over a 60 minute session.
|
Stage I: One Spray CTY-5339-P
n=5 Participants
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.
|
|---|---|---|---|
|
Stage I: Onset of Anesthesia for Heat Sensation Threshold (QST Heat)
|
2.0 minutes
Standard Deviation 2.9
|
0.4 minutes
Standard Deviation 0.7
|
0.8 minutes
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Any time within one hour post-applicationPopulation: Placebo percentage of response was not analyzed.
Response is defined as a subject having a PPT average pain score of ≤2 recorded at any single time point where PPT was performed. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Stage I outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=10 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=10 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. Tested over a 60 minute session.
|
Stage I: One Spray CTY-5339-P
n=5 Participants
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.
|
|---|---|---|---|
|
Stage I: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)
|
10 Participants
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to one hour post-applicationSPID was calculated as a sum of the delta PPT scores at each time point until the designated time point. The delta PPT score is defined as the change in PPT score from baseline. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The total possible scale range was from -100 (best) to +100 (worst) for SPID at the 30 minute time point, and from -160 (best) to +160 (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective). Stage I outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=10 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=10 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. Tested over a 60 minute session.
|
Stage I: One Spray CTY-5339-P
n=5 Participants
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.
|
|---|---|---|---|
|
Stage I: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc)
SPID at the 30 minute time point
|
-82.1 score
Standard Deviation 34.9
|
-37.8 score
Standard Deviation 42.3
|
-29.3 score
Standard Deviation 36.3
|
|
Stage I: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc)
SPID at the 60 minute time point
|
-128.1 score
Standard Deviation 76.6
|
-44.0 score
Standard Deviation 52.7
|
-53.3 score
Standard Deviation 69.1
|
SECONDARY outcome
Timeframe: Up to one hour post-applicationSTID was calculated as a sum of the delta QST Heat scores at each time point until the designated time point. The delta QST Heat score is defined as the change in QST Heat score from baseline. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The total possible scale range was from -155 ºC (best) to +155 ºC (worst) for STID at the 30 minute time point, and from -248 ºC (best) to +248 ºC (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective). Stage I outcome.
Outcome measures
| Measure |
One Spray CTY-5339-A
n=10 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. Tested over a 60 minute session.
|
One Spray CTY-5339-CB
n=10 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. Tested over a 60 minute session.
|
Stage I: One Spray CTY-5339-P
n=5 Participants
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.
|
|---|---|---|---|
|
Stage I: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc)
STID at the 30 minute time point
|
153.0 Degrees Celcius (ºC)
Standard Deviation 72.0
|
10.4 Degrees Celcius (ºC)
Standard Deviation 89.4
|
72.5 Degrees Celcius (ºC)
Standard Deviation 33.6
|
|
Stage I: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc)
STID at the 60 minute time point
|
320.2 Degrees Celcius (ºC)
Standard Deviation 167.2
|
26.1 Degrees Celcius (ºC)
Standard Deviation 137.0
|
134.6 Degrees Celcius (ºC)
Standard Deviation 94.3
|
Adverse Events
One Spray CTY-5339-A
One Spray CTY-5339-CB
One Spray CTY-5339-P
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
One Spray CTY-5339-A
n=60 participants at risk
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.
|
One Spray CTY-5339-CB
n=60 participants at risk
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.
|
One Spray CTY-5339-P
n=5 participants at risk
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.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
1.7%
1/60 • Number of events 1 • Adverse event data collected during and for one hour post testing.
|
0.00%
0/60 • Adverse event data collected during and for one hour post testing.
|
0.00%
0/5 • Adverse event data collected during and for one hour post testing.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.7%
1/60 • Number of events 1 • Adverse event data collected during and for one hour post testing.
|
0.00%
0/60 • Adverse event data collected during and for one hour post testing.
|
0.00%
0/5 • Adverse event data collected during and for one hour post testing.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.7%
1/60 • Number of events 1 • Adverse event data collected during and for one hour post testing.
|
0.00%
0/60 • Adverse event data collected during and for one hour post testing.
|
0.00%
0/5 • Adverse event data collected during and for one hour post testing.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis streptococcal
|
0.00%
0/60 • Adverse event data collected during and for one hour post testing.
|
1.7%
1/60 • Number of events 1 • Adverse event data collected during and for one hour post testing.
|
0.00%
0/5 • Adverse event data collected during and for one hour post testing.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/60 • Adverse event data collected during and for one hour post testing.
|
1.7%
1/60 • Number of events 1 • Adverse event data collected during and for one hour post testing.
|
0.00%
0/5 • Adverse event data collected during and for one hour post testing.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/60 • Adverse event data collected during and for one hour post testing.
|
1.7%
1/60 • Number of events 1 • Adverse event data collected during and for one hour post testing.
|
0.00%
0/5 • 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place