Trial Outcomes & Findings for Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Adults (NCT NCT01745380)

NCT ID: NCT01745380

Last Updated: 2017-01-31

Results Overview

If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 150 participants
• Primary outcome timeframe: at 15 minutes, +3 minute window
• Results posted on: 2017-01-31

Participant Flow

Subjects were screened and enrolled at 3 sites in the U.S.

Participant milestones

Measure	Kovacaine Mist Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Overall Study STARTED	100	50
Overall Study COMPLETED	99	49
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Kovacaine Mist Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Overall Study Lost to Follow-up	1	0
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Adults

Baseline characteristics by cohort

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo	Total n=150 Participants Total of all reporting groups
Age, Continuous	41.6 years STANDARD_DEVIATION 13.98 • n=5 Participants	40.3 years STANDARD_DEVIATION 15.23 • n=7 Participants	41.2 years STANDARD_DEVIATION 14.37 • n=5 Participants
Gender Female	57 Participants n=5 Participants	25 Participants n=7 Participants	82 Participants n=5 Participants
Gender Male	43 Participants n=5 Participants	25 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants	43 Participants n=7 Participants	131 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	4 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants	30 Participants n=7 Participants	94 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	50 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: at 15 minutes, +3 minute window

If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.	88 participants	14 participants

SECONDARY outcome

Timeframe: at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used

Population: Participants were only analyzed in their corresponding age group.

If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome. This outcome is broken down by age group, 1) less than 50 years of age and 2) 50 years of age and older.

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years) less or = to 50	87 percentage of participants	20.6 percentage of participants
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years) greater than 50	90.3 percentage of participants	43.8 percentage of participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Number of Participants With a Heart Rate Higher Than 125 Bpm	0 participants	0 participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Number of Participants With a Heart Rate Lower Than 50 Bpm	4 participants	1 participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and/or to a Value Higher Than 160 mm Hg	5 participants	2 participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following study drug administration

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Lower Than 90 mm Hg	1 participants	1 participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following study drug administration

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Higher Than 105 mm Hg	1 participants	1 participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following study drug administration

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and/or to a Value Lower Than 50 mm Hg	1 participants	0 participants

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Maximum Change From Baseline in Heart Rate	5.3 bpm Standard Deviation 7.81	5.1 bpm Standard Deviation 9.02

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Maximum Change From Baseline in Systolic Blood Pressure	13.8 mmHg Standard Deviation 10.18	9.2 mmHg Standard Deviation 10.23

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Maximum Change From Baseline in Diastolic Blood Pressure	11.1 mmHg Standard Deviation 6.40	6.4 mmHg Standard Deviation 6.53

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
The Profile Over Time of Heart Rate pre-study	71.0 beats per minute Standard Deviation 10.37	73.6 beats per minute Standard Deviation 10.50
The Profile Over Time of Heart Rate 10 mins	68.0 beats per minute Standard Deviation 10.66	72.6 beats per minute Standard Deviation 10.17
The Profile Over Time of Heart Rate 30 mins	67.5 beats per minute Standard Deviation 10.86	66.3 beats per minute Standard Deviation 3.21
The Profile Over Time of Heart Rate 45 mins	66.4 beats per minute Standard Deviation 10.52	70.9 beats per minute Standard Deviation 9.29
The Profile Over Time of Heart Rate 60 mins	65.8 beats per minute Standard Deviation 10.26	69.2 beats per minute Standard Deviation 9.99
The Profile Over Time of Heart Rate 90 mins	65.6 beats per minute Standard Deviation 10.27	67.7 beats per minute Standard Deviation 10.44
The Profile Over Time of Heart Rate 120 mins	65.6 beats per minute Standard Deviation 9.65	68.9 beats per minute Standard Deviation 10.49

SECONDARY outcome

Timeframe: administered at approximately 24 hours after drug administration

The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on a cotton ball.

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Alcohol Sniff Test	-0.8 cm Standard Deviation 5.85	1.3 cm Standard Deviation 6.17

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
The Profile Over Time of Systolic Blood Pressure pre-study	123.1 mmHg Standard Deviation 14.12	124.0 mmHg Standard Deviation 13.70
The Profile Over Time of Systolic Blood Pressure 10 mins	128.6 mmHg Standard Deviation 15.20	125.4 mmHg Standard Deviation 16.02
The Profile Over Time of Systolic Blood Pressure 30 mins	117.3 mmHg Standard Deviation 13.54	116.3 mmHg Standard Deviation 10.26
The Profile Over Time of Systolic Blood Pressure 45 mins	125.0 mmHg Standard Deviation 18.47	124.8 mmHg Standard Deviation 18.27
The Profile Over Time of Systolic Blood Pressure 60 mins	127.1 mmHg Standard Deviation 16.62	126.7 mmHg Standard Deviation 18.79
The Profile Over Time of Systolic Blood Pressure 90 mins	128.8 mmHg Standard Deviation 16.53	126.1 mmHg Standard Deviation 15.89
The Profile Over Time of Systolic Blood Pressure 120 mins	129.5 mmHg Standard Deviation 17.97	124.9 mmHg Standard Deviation 15.54

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist n=100 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
The Profile Over Time of Diastolic Blood Pressure pre-study	73.5 mmHg Standard Deviation 9.37	74.7 mmHg Standard Deviation 8.99
The Profile Over Time of Diastolic Blood Pressure 10 mins	78.5 mmHg Standard Deviation 10.64	75.2 mmHg Standard Deviation 10.65
The Profile Over Time of Diastolic Blood Pressure 30 mins	74.4 mmHg Standard Deviation 9.13	67.0 mmHg Standard Deviation 7.00
The Profile Over Time of Diastolic Blood Pressure 45 mins	76.4 mmHg Standard Deviation 10.50	74.7 mmHg Standard Deviation 12.45
The Profile Over Time of Diastolic Blood Pressure 60 mins	76.6 mmHg Standard Deviation 10.71	76.7 mmHg Standard Deviation 12.33
The Profile Over Time of Diastolic Blood Pressure 90 mins	77.8 mmHg Standard Deviation 10.53	75.4 mmHg Standard Deviation 10.07
The Profile Over Time of Diastolic Blood Pressure 120 mins	79.3 mmHg Standard Deviation 10.75	75.4 mmHg Standard Deviation 10.27

OTHER_PRE_SPECIFIED outcome

Timeframe: at 25 minutes, +3 minute window

Population: This analysis is only of the participants who received 3 sprays. It does not include participants who only received 2 sprays.

A participant will receive two sprays and Study Dental Procedure will begin. If the participant does not have sufficient anesthesia a third sprays will be given. If after the third spray, the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic. This outcome analyzes just the participants who received the third spray and whether or not they completed the Study Dental Procedure without need for rescue by injection of local anesthesia.

Outcome measures

Measure	Kovacaine Mist n=27 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=33 Participants Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Number of Participants Who Received Three Sprays and Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.	16 participants	0 participants

Adverse Events

Kovacaine Mist

Serious events: 0 serious events

Other events: 83 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Kovacaine Mist n=100 participants at risk Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Placebo n=50 participants at risk Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	57.0% 57/100 • Approximately 24 hours following drug administration	6.0% 3/50 • Approximately 24 hours following drug administration
Respiratory, thoracic and mediastinal disorders Nasal Congestion	27.0% 27/100 • Approximately 24 hours following drug administration	6.0% 3/50 • Approximately 24 hours following drug administration
Respiratory, thoracic and mediastinal disorders Nasal Discomfort	24.0% 24/100 • Approximately 24 hours following drug administration	4.0% 2/50 • Approximately 24 hours following drug administration
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	15.0% 15/100 • Approximately 24 hours following drug administration	0.00% 0/50 • Approximately 24 hours following drug administration
Respiratory, thoracic and mediastinal disorders Throat Irritation	8.0% 8/100 • Approximately 24 hours following drug administration	0.00% 0/50 • Approximately 24 hours following drug administration
Respiratory, thoracic and mediastinal disorders Rhinalgia	5.0% 5/100 • Approximately 24 hours following drug administration	2.0% 1/50 • Approximately 24 hours following drug administration
Nervous system disorders Dysgeusia	7.0% 7/100 • Approximately 24 hours following drug administration	2.0% 1/50 • Approximately 24 hours following drug administration
Nervous system disorders Headache	9.0% 9/100 • Approximately 24 hours following drug administration	2.0% 1/50 • Approximately 24 hours following drug administration
Eye disorders Lacrimation Increased	8.0% 8/100 • Approximately 24 hours following drug administration	4.0% 2/50 • Approximately 24 hours following drug administration
Investigations Systolic BP Increased	8.0% 8/100 • Approximately 24 hours following drug administration	4.0% 2/50 • Approximately 24 hours following drug administration
Investigations Diastolic BP Increased	6.0% 6/100 • Approximately 24 hours following drug administration	2.0% 1/50 • Approximately 24 hours following drug administration
Respiratory, thoracic and mediastinal disorders Intranasal Hypoaesthesia	9.0% 9/100 • Approximately 24 hours following drug administration	2.0% 1/50 • Approximately 24 hours following drug administration

Additional Information

Elliott V. Hersh, Principal Investigator

University of Pennsylvania School of Dental Medicine

Phone: 215-898-9686

Email: evhersh@pobox.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place