Trial Outcomes & Findings for Safety and Pharmacokinetics of Kovacaine Nasal Spray (24 Hour Blood Collection) (NCT NCT01807624)

NCT ID: NCT01807624

Last Updated: 2017-08-30

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
• Results posted on: 2017-08-30

Participant Flow

Participant milestones

Measure	Kovacaine Nasal Spray Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Pharmacokinetics of Kovacaine Nasal Spray (24 Hour Blood Collection)

Baseline characteristics by cohort

Measure	Kovacaine Nasal Spray n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
Age, Continuous	28.7 years STANDARD_DEVIATION 9.36 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Outcome measures

Measure	Kovacaine Nasal Spray n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
Cmax of Oxymetazoline and PBBA Oxymetazoline	1.79 ng/mL Standard Deviation 0.586
Cmax of Oxymetazoline and PBBA PBBA	465 ng/mL Standard Deviation 122

PRIMARY outcome

Timeframe: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Outcome measures

Measure	Kovacaine Nasal Spray n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
Tmax of Oxymetazoline and PBBA Oxymetazoline	5.8 minutes Standard Deviation 1.9
Tmax of Oxymetazoline and PBBA PBBA	22 minutes Standard Deviation 6.6

PRIMARY outcome

Timeframe: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Outcome measures

Measure	Kovacaine Nasal Spray n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
Half-life of Oxymetazoline and PBBA Oxymetazoline	5.23 minutes Standard Deviation 2.2
Half-life of Oxymetazoline and PBBA PBBA	2.6 minutes Standard Deviation 1.23

PRIMARY outcome

Timeframe: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Outcome measures

Measure	Kovacaine Nasal Spray n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
AUC0-t of Oxymetazoline and PBBA Oxymetazoline	3.67 ng*h/mL Standard Deviation 1.79
AUC0-t of Oxymetazoline and PBBA PBBA	960 ng*h/mL Standard Deviation 509

PRIMARY outcome

Timeframe: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Outcome measures

Measure	Kovacaine Nasal Spray n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
AUC0-infinity of Oxymetazoline and PBBA Oxymetazoline	4.24 ng*h/mL Standard Deviation 2.09
AUC0-infinity of Oxymetazoline and PBBA PBBA	973 ng*h/mL Standard Deviation 513

SECONDARY outcome

Timeframe: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Outcome measures

Measure	Kovacaine Nasal Spray n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
Increase in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication	3 participants

SECONDARY outcome

Timeframe: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Outcome measures

Measure	Kovacaine Nasal Spray n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
Decrease in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication	0 participants

SECONDARY outcome

Timeframe: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Outcome measures

Measure	Kovacaine Nasal Spray n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
Increase in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication	1 participants

SECONDARY outcome

Timeframe: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Outcome measures

Measure	Kovacaine Nasal Spray n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
Decrease in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication	0 participants

SECONDARY outcome

Timeframe: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Outcome measures

Measure	Kovacaine Nasal Spray n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
Increase in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication	2 participants

SECONDARY outcome

Timeframe: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Outcome measures

Measure	Kovacaine Nasal Spray n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
Decrease in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication	2 participants

SECONDARY outcome

Timeframe: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Outcome measures

Measure	Kovacaine Nasal Spray n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
SpO2 Increase of > 5% on 2 Consecutive Measurements After Administration of Study Medication	0 participants

SECONDARY outcome

Timeframe: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray

Outcome measures

Measure	Kovacaine Nasal Spray n=24 Participants Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
SpO2 Decrease of > 5% on 2 Consecutive Measurements After Administration of Study Medication	0 participants

Adverse Events

Kovacaine Nasal Spray

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Kovacaine Nasal Spray n=24 participants at risk Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl
Gastrointestinal disorders Nausea	12.5% 3/24 • 2 days
Nervous system disorders Headache	25.0% 6/24 • 2 days
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 3/24 • 2 days
Respiratory, thoracic and mediastinal disorders Nasal congestion	20.8% 5/24 • 2 days
Respiratory, thoracic and mediastinal disorders Nasal discomfort	20.8% 5/24 • 2 days
Respiratory, thoracic and mediastinal disorders Rhinorrhea	45.8% 11/24 • 2 days
Respiratory, thoracic and mediastinal disorders Throat irritation	20.8% 5/24 • 2 days
Respiratory, thoracic and mediastinal disorders Pharyngeal Hypoaesthesia	29.2% 7/24 • 2 days

Additional Information

Dr. Derek Muse

Jean Brown Research Center

Phone: (801) 261-2000

Email: participate@jeanbrownresearch.com

Results disclosure agreements

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