NCT02908620

Experimental Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 Anesthetic Spray in Normal Volunteers

Completed Phase 2 Results posted Last updated 2 July 2019

What this trial tests

Phase 2 trial testing One spray CTY-5339-A in Anesthesia in 40 participants. Completed in 7 June 2017.

Timeline

7 December 2016

Primary endpoint
2 April 2017

7 June 2017

Quick facts

Lead sponsor	Cetylite Industries
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	40
Start date	7 December 2016
Primary completion	2 April 2017
Estimated completion	7 June 2017
Sites	1 location across United States

Drugs / interventions tested

• One spray CTY-5339-A
• One spray CTY-5339-CB — full drug profile →
• Two sprays CTY-5339-A
• One spray CTY-5339-CB in combination with one spray CTY-5339-P (vehicle control: placebo) — full drug profile →

Conditions studied

• Anesthesia — all drugs for Anesthesia →

Sponsor

Cetylite Industries — full company profile →

Who can join

Adults 18 to 75, any sex, with Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Primary · Change in pain assessment from baseline (time of application) up to one hour post-application

Evaluations were completed at 1-minute intervals for the first 5 minutes to capture onset of anesthesia. Starting at 5 minutes after drug administration, the PPT was done at 5 minute intervals up to the one hour time point. If there was no indication of anesthesia by 10 minutes, the subject was considered a treatment failure and the assessment of PPT was discontinued. In addition, once onset of anesthesia had occurred, if there was no longer any anesthesia at two consecutive evaluation time points from 10 minutes onward, the assessment of PPT was discontinued. The PPT was assessed using a 90-

Group	Value	95% CI
One Spray CTY-5339-A	17.9	± 12.9
One Spray CTY-5339-CB	16.4	± 14.8

Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Primary · Change in temperature from baseline (time of application) up to one hour post-application

Starting at 5 minutes after drug administration, the QST was done at 5 minute intervals up to the one hour time point. If there was no indication of anesthesia by 10 minutes, the subject was considered a treatment failure and the assessment of PPT was discontinued. In addition, once onset of anesthesia had occurred, if there was no longer any anesthesia at two consecutive evaluation time points from 10 minutes onward, the assessment of QST was discontinued. The heat stimuli were delivered in 3 repetitions, with inter-stimulus intervals of 30s. The basal thermode temperature was set at a comfo

Group	Value	95% CI
One Spray CTY-5339-A	44.6	± 17.8
One Spray CTY-5339-CB	51.1	± 12.9

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) Secondary · Time of application up to one hour post-application

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).

Group	Value	95% CI
Two Sprays CTY-5339-A	17.3	± 17.0
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	13.5	± 14.7

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) Secondary · Time of application up to one hour post-application

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).

Group	Value	95% CI
Two Sprays CTY-5339-A	46.8	± 17.3
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	38.9	± 20.3

Duration of Anesthesia as Measured by PPT for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A Secondary · Time of application up to one hour post-application

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.

Group	Value	95% CI
One Spray CTY-5339-A	17.9	± 12.9
Two Sprays CTY-5339-A	17.3	± 17.0

Duration of Anesthesia as Measured by QST Heat for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A Secondary · Time of application up to one hour post-application

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.

Group	Value	95% CI
One Spray CTY-5339-A	44.6	± 17.8
Two Sprays CTY-5339-A	46.8	± 17.3

Onset of Anesthesia for PPT Secondary · Time of application up to one hour post-application

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.

Group	Value	95% CI
One Spray CTY-5339-A	1.2	± 0.4
Two Sprays CTY-5339-A	1.5	± 0.9
One Spray CTY-5339-CB	1.7	± 2.1
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	1.7	± 1.3

Onset of Anesthesia for QST Heat Secondary · Time of application up to one hour post-application

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.

Group	Value	95% CI
One Spray CTY-5339-A	3.1	± 3.3
Two Sprays CTY-5339-A	1.9	± 1.4
One Spray CTY-5339-CB	1.7	± 1.3
CTY-5339-CB 1 Spray + Placebo 1 Spray	4.2	± 5.2

Percentage of Responders for PPT at Each Time Point Secondary · Time of application up to one hour post-application

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.

Responded to treatment at the 1 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	12
Two Sprays CTY-5339-A	12
One Spray CTY-5339-CB	14
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	10

Responded to treatment at the 2 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	13
Two Sprays CTY-5339-A	9
One Spray CTY-5339-CB	14
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	13

Responded to treatment at the 3 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	12
Two Sprays CTY-5339-A	11
One Spray CTY-5339-CB	12
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	10

Responded to treatment at the 4 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	12
Two Sprays CTY-5339-A	12
One Spray CTY-5339-CB	8
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	8

Responded to treatment at the 5 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	10
Two Sprays CTY-5339-A	7
One Spray CTY-5339-CB	7
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	9

Responded to treatment at the 10 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	5
Two Sprays CTY-5339-A	6
One Spray CTY-5339-CB	8
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	6

Responded to treatment at the 15 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	8
Two Sprays CTY-5339-A	5
One Spray CTY-5339-CB	6
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	4

Responded to treatment at the 20 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	4
Two Sprays CTY-5339-A	6
One Spray CTY-5339-CB	4
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	2

Percentage of Responders for QST Heat at Each Time Point Secondary · Time of application up to one hour post-application

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.

Responded to treatment at the 5 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	16
Two Sprays CTY-5339-A	18
One Spray CTY-5339-CB	18
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	15

Responded to treatment at the 10 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	17
Two Sprays CTY-5339-A	17
One Spray CTY-5339-CB	17
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	13

Responded to treatment at the 15 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	15
Two Sprays CTY-5339-A	17
One Spray CTY-5339-CB	18
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	15

Responded to treatment at the 20 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	17
Two Sprays CTY-5339-A	15
One Spray CTY-5339-CB	17
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	14

Responded to treatment at the 25 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	15
Two Sprays CTY-5339-A	15
One Spray CTY-5339-CB	15
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	14

Responded to treatment at the 30 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	14
Two Sprays CTY-5339-A	14
One Spray CTY-5339-CB	14
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	13

Responded to treatment at the 35 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	13
Two Sprays CTY-5339-A	12
One Spray CTY-5339-CB	17
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	12

Responded to treatment at the 40 minute time point

Group	Value	95% CI
One Spray CTY-5339-A	12
Two Sprays CTY-5339-A	11
One Spray CTY-5339-CB	16
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P	12

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data collected during and for one hour post testing.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CTY-5339-A 1 Spray

Serious: 0/20 (0%)

Deaths: 0/20

CTY-5339-A 2 Sprays

Serious: 0/20 (0%)

Deaths: 0/20

CTY-5339-CB 1 Spray

Serious: 0/20 (0%)

Deaths: 0/20

CTY-5339-CB 1 Spray + Placebo 1 Spray

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (1 terms — click to expand)

Reaction	System	CTY-5339-A 1 Spray	CTY-5339-A 2 Sprays	CTY-5339-CB 1 Spray	CTY-5339-CB 1 Spray + Plac…
Feeling faint	Nervous system disorders	—	—	—	—

Data from ClinicalTrials.gov NCT02908620 adverse events section.

Sponsor's own description

The purpose of this study is to determine if the topical application to cheek tissue of the combination of benzocaine and tetracaine has a longer duration of local anesthetic activity than benzocaine alone.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Lack of Methemoglobin Elevations After Topical Applications of Benzocaine Alone or Benzocaine Plus Tetracaine to the Oral Mucosa.
   Wang S, Giannakopoulos H, Lowstetter J, Kaye L, et al · · 2017 · cited 2× · PMID 28943117 · DOI 10.1016/j.clinthera.2017.08.017