Trial Outcomes & Findings for Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth in Adults (NCT NCT01710787)

NCT ID: NCT01710787

Last Updated: 2017-08-30

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: 110 participants
• Primary outcome timeframe: at 15 minutes with a 3 minute window
• Results posted on: 2017-08-30

Participant Flow

Participant milestones

Measure	Kovacaine Mist, 3 Sprays Unilateral Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral Placebo Placebo: 3 unilateral intranasal sprays per dose
Overall Study STARTED	44	44	22
Overall Study COMPLETED	44	44	22
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose	Total n=110 Participants Total of all reporting groups
Age, Continuous	37.1 years STANDARD_DEVIATION 14.73 • n=5 Participants	31.3 years STANDARD_DEVIATION 12.01 • n=7 Participants	35.7 years STANDARD_DEVIATION 14.64 • n=5 Participants	34.5 years STANDARD_DEVIATION 13.82 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	16 Participants n=7 Participants	12 Participants n=5 Participants	58 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	28 Participants n=7 Participants	10 Participants n=5 Participants	52 Participants n=4 Participants

PRIMARY outcome

Timeframe: at 15 minutes with a 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, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic.	84.1 percentage of patients Interval 69.9 to 93.4	27.3 percentage of patients Interval 15.0 to 42.8	27.3 percentage of patients Interval 10.7 to 50.2

SECONDARY outcome

Timeframe: at Baseline, 15, 30, 45, 60, 90, and 120 minutes with a 3 minute window

Population: Only patients from one site (out of the two sites for the study) are used for this analysis. The other site administered this assessment incorrectly.

Number of patients who reported no pain when incisive papilla soft-tissue was tested with a probe at designated timepoints

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=24 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=12 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Intraoral Soft-tissue Anesthesia (Yes/no) Baseline	0 Participants	0 Participants	0 Participants
Intraoral Soft-tissue Anesthesia (Yes/no) 15 mins	19 Participants	8 Participants	0 Participants
Intraoral Soft-tissue Anesthesia (Yes/no) 30 mins	17 Participants	3 Participants	0 Participants
Intraoral Soft-tissue Anesthesia (Yes/no) 45 mins	21 Participants	5 Participants	3 Participants
Intraoral Soft-tissue Anesthesia (Yes/no) 60 mins	17 Participants	2 Participants	1 Participants
Intraoral Soft-tissue Anesthesia (Yes/no) 90 mins	10 Participants	1 Participants	0 Participants
Intraoral Soft-tissue Anesthesia (Yes/no) 120 mins	5 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Number of Participants With a Heart Rate Higher Than 125 Bpm	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Number of Participants With a Heart Rate Lower Than 50 Bpm	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 105 mm Hg	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: at any time within 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and to a Value Lower Than 50 mm Hg	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Absolute Maximum Change From Baseline in Heart Rate	9.4 bpm Standard Deviation 11.53	10.5 bpm Standard Deviation 10.74	7.0 bpm Standard Deviation 7.97

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Absolute Maximum Change From Baseline in Systolic Blood Pressure	13.7 mm Hg Standard Deviation 10.74	10.8 mm Hg Standard Deviation 9.15	5.1 mm Hg Standard Deviation 9.32

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Absolute Maximum Change From Baseline in Diastolic Blood Pressure	10.5 mmHg Standard Deviation 7.12	7.3 mmHg Standard Deviation 4.96	6.7 mmHg Standard Deviation 4.91

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
The Profile Over Time of Heart Rate Pre-Study (Baseline)	76.5 beats per minute Standard Deviation 13.10	75.1 beats per minute Standard Deviation 10.25	74.8 beats per minute Standard Deviation 10.65
The Profile Over Time of Heart Rate 10 mins	75.3 beats per minute Standard Deviation 19.25	76 beats per minute Standard Deviation 12.03	76.3 beats per minute Standard Deviation 12.88
The Profile Over Time of Heart Rate 30 mins	69.8 beats per minute Standard Deviation 17.52	82.6 beats per minute Standard Deviation 10.81	76.0 beats per minute Standard Deviation 17.15
The Profile Over Time of Heart Rate 45 mins	72.8 beats per minute Standard Deviation 16.76	74.1 beats per minute Standard Deviation 9.40	73.1 beats per minute Standard Deviation 12.35
The Profile Over Time of Heart Rate 60 mins	71.3 beats per minute Standard Deviation 17.81	73.2 beats per minute Standard Deviation 12.03	73.0 beats per minute Standard Deviation 10.95
The Profile Over Time of Heart Rate 90 mins	73.1 beats per minute Standard Deviation 18.79	72.0 beats per minute Standard Deviation 13.12	72.1 beats per minute Standard Deviation 11.44
The Profile Over Time of Heart Rate 120 mins	71.4 beats per minute Standard Deviation 15.51	73.8 beats per minute Standard Deviation 12.37	73.7 beats per minute Standard Deviation 9.92

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
The Profile Over Time of Systolic Blood Pressure Pre-Study (Baseline)	121.3 mmHg Standard Deviation 12.09	118.6 mmHg Standard Deviation 10.15	118.5 mmHg Standard Deviation 11.76
The Profile Over Time of Systolic Blood Pressure 10 mins	125.0 mmHg Standard Deviation 12.49	122.0 mmHg Standard Deviation 13.01	121.5 mmHg Standard Deviation 14.44
The Profile Over Time of Systolic Blood Pressure 30 mins	123.5 mmHg Standard Deviation 16.65	122.2 mmHg Standard Deviation 14.06	130.5 mmHg Standard Deviation 5.45
The Profile Over Time of Systolic Blood Pressure 45 mins	121.7 mmHg Standard Deviation 14.2	125.1 mmHg Standard Deviation 12.12	118.7 mmHg Standard Deviation 14.17
The Profile Over Time of Systolic Blood Pressure 60 mins	123.1 mmHg Standard Deviation 14.16	121.7 mmHg Standard Deviation 13.14	117.5 mmHg Standard Deviation 11.40
The Profile Over Time of Systolic Blood Pressure 90 mins	124.3 mmHg Standard Deviation 15.55	122.1 mmHg Standard Deviation 16.30	116.6 mmHg Standard Deviation 10.76
The Profile Over Time of Systolic Blood Pressure 120 mins	125.0 mmHg Standard Deviation 15.75	121.1 mmHg Standard Deviation 12.97	115.7 mmHg Standard Deviation 9.36

SECONDARY outcome

Timeframe: from baseline to 120 minutes following drug administration

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
The Profile Over Time of Diastolic Blood Pressure Pre-Study (Baseline)	75.0 mmHg Standard Deviation 7.92	75.3 mmHg Standard Deviation 8.25	74.8 mmHg Standard Deviation 7.20
The Profile Over Time of Diastolic Blood Pressure 10 mins	79.6 mmHg Standard Deviation 10.44	77.7 mmHg Standard Deviation 8.36	77.3 mmHg Standard Deviation 9.29
The Profile Over Time of Diastolic Blood Pressure 30 mins	81.7 mmHg Standard Deviation 10.91	79.6 mmHg Standard Deviation 10.16	84.5 mmHg Standard Deviation 5.51
The Profile Over Time of Diastolic Blood Pressure 45 mins	77.1 mmHg Standard Deviation 9.06	78.7 mmHg Standard Deviation 9.03	75.4 mmHg Standard Deviation 9.73
The Profile Over Time of Diastolic Blood Pressure 60 mins	79.0 mmHg Standard Deviation 10.63	76.8 mmHg Standard Deviation 9.01	76.6 mmHg Standard Deviation 7.33
The Profile Over Time of Diastolic Blood Pressure 90 mins	79.3 mmHg Standard Deviation 10.91	75.7 mmHg Standard Deviation 8.56	74.1 mmHg Standard Deviation 5.42
The Profile Over Time of Diastolic Blood Pressure 120 mins	77.8 mmHg Standard Deviation 8.85	76.9 mmHg Standard Deviation 8.84	75.7 mmHg Standard Deviation 6.83

SECONDARY outcome

Timeframe: administered at baseline, 120 minutes and approximately 24 hours after drug administration

The distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on an alcohol swab.

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Alcohol Sniff Test Pre-Study (Baseline)	19.2 cm Standard Deviation 8.96	18.8 cm Standard Deviation 10	21.2 cm Standard Deviation 8.35
Alcohol Sniff Test 120 Minutes	18 cm Standard Deviation 9.47	17.7 cm Standard Deviation 9.48	20.9 cm Standard Deviation 8.13
Alcohol Sniff Test 24 Hours	18.2 cm Standard Deviation 8.51	16.1 cm Standard Deviation 8.74	20.4 cm Standard Deviation 8.38

SECONDARY outcome

Timeframe: up to 120 mins post-dose

Population: The analysis population includes patients who received a rescue injection of local anesthetic. Local anesthetic may cause soft-tissue anesthesia, impacting this endpoint. In addition, only patients from one site (out of the two sites for the study) are used for this analysis. The other site administered this assessment incorrectly.

Mean onset and duration of incisive papilla anesthesia based on number of patients who reported no pain when soft-tissue was tested with a probe at designated timepoints

Outcome measures

Measure	Kovacaine Mist, 3 Sprays Unilateral n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=24 Participants Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=12 Participants Placebo Placebo: 3 unilateral intranasal sprays per dose
Intraoral Soft-tissue Anesthesia (Onset and Duration) Onset	9.7 minutes Standard Deviation 7.5	19.5 minutes Standard Deviation 17.6	37.0 minutes Standard Deviation 0.0
Intraoral Soft-tissue Anesthesia (Onset and Duration) Duration	79.2 minutes Standard Deviation 27.0	32.1 minutes Standard Deviation 15.2	26.0 minutes Standard Deviation 17.3

Adverse Events

Kovacaine Mist, 3 Sprays Unilateral

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Tetracaine Only, 3 Sprays Unilateral

Serious events: 1 serious events

Other events: 44 other events

Deaths: 0 deaths

Placebo, 3 Sprays Unilateral

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 participants at risk Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 participants at risk Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 participants at risk Placebo Placebo: 3 unilateral intranasal sprays per dose
Infections and infestations Cellulitis Orbital	0.00% 0/44 • 24 hours post-dosing	2.3% 1/44 • 24 hours post-dosing	0.00% 0/22 • 24 hours post-dosing
Nervous system disorders Headache	0.00% 0/44 • 24 hours post-dosing	2.3% 1/44 • 24 hours post-dosing	0.00% 0/22 • 24 hours post-dosing
Infections and infestations Sinusitis	0.00% 0/44 • 24 hours post-dosing	2.3% 1/44 • 24 hours post-dosing	0.00% 0/22 • 24 hours post-dosing

Other adverse events

Measure	Kovacaine Mist, 3 Sprays Unilateral n=44 participants at risk Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose	Tetracaine Only, 3 Sprays Unilateral n=44 participants at risk Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	Placebo, 3 Sprays Unilateral n=22 participants at risk Placebo Placebo: 3 unilateral intranasal sprays per dose
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	38.6% 17/44 • 24 hours post-dosing	36.4% 16/44 • 24 hours post-dosing	0.00% 0/22 • 24 hours post-dosing
Respiratory, thoracic and mediastinal disorders Nasal congestion	34.1% 15/44 • 24 hours post-dosing	61.4% 27/44 • 24 hours post-dosing	13.6% 3/22 • 24 hours post-dosing
Respiratory, thoracic and mediastinal disorders Nasal discomfort	22.7% 10/44 • 24 hours post-dosing	11.4% 5/44 • 24 hours post-dosing	4.5% 1/22 • 24 hours post-dosing
Respiratory, thoracic and mediastinal disorders Pharyngeal hypoaesthesia	15.9% 7/44 • 24 hours post-dosing	18.2% 8/44 • 24 hours post-dosing	0.00% 0/22 • 24 hours post-dosing
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	13.6% 6/44 • 24 hours post-dosing	9.1% 4/44 • 24 hours post-dosing	0.00% 0/22 • 24 hours post-dosing
Respiratory, thoracic and mediastinal disorders Throat irritation	9.1% 4/44 • 24 hours post-dosing	2.3% 1/44 • 24 hours post-dosing	0.00% 0/22 • 24 hours post-dosing
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	9.1% 4/44 • 24 hours post-dosing	2.3% 1/44 • 24 hours post-dosing	0.00% 0/22 • 24 hours post-dosing
Nervous system disorders Headache	13.6% 6/44 • 24 hours post-dosing	2.3% 1/44 • 24 hours post-dosing	4.5% 1/22 • 24 hours post-dosing
Eye disorders Lacrimation increased	15.9% 7/44 • 24 hours post-dosing	9.1% 4/44 • 24 hours post-dosing	0.00% 0/22 • 24 hours post-dosing
Vascular disorders Hypertension	9.1% 4/44 • 24 hours post-dosing	2.3% 1/44 • 24 hours post-dosing	4.5% 1/22 • 24 hours post-dosing
Respiratory, thoracic and mediastinal disorders Intranasal Hypoaesthesia	15.9% 7/44 • 24 hours post-dosing	11.4% 5/44 • 24 hours post-dosing	9.1% 2/22 • 24 hours post-dosing
Gastrointestinal disorders Toothache	4.5% 2/44 • 24 hours post-dosing	22.7% 10/44 • 24 hours post-dosing	22.7% 5/22 • 24 hours post-dosing
Cardiac disorders Bradycardia	9.1% 4/44 • 24 hours post-dosing	4.5% 2/44 • 24 hours post-dosing	4.5% 1/22 • 24 hours post-dosing
Cardiac disorders Tachycardia	6.8% 3/44 • 24 hours post-dosing	4.5% 2/44 • 24 hours post-dosing	0.00% 0/22 • 24 hours post-dosing

Additional Information

Adam D. Marberger, DDS

Jean Brown Research

Phone: 801-261-2000

Results disclosure agreements

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