Trial Outcomes & Findings for Open-Label Study of Efficacy and Recommended Dose of Kovacaine Mist for Anesthetizing Maxillary Teeth (NCT NCT01479517)
NCT ID: NCT01479517
Last Updated: 2016-12-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
at 15 minutes, with +10 minute window
Results posted on
2016-12-29
Participant Flow
Participant milestones
| Measure |
Kovacaine Mist 0.1 mL x 4 Sprays
Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.
|
Kovacaine Mist 0.2 mL x 2 Sprays
Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.
|
Kovacaine Mist, 0.2 mL x 1 Spray
Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Study of Efficacy and Recommended Dose of Kovacaine Mist for Anesthetizing Maxillary Teeth
Baseline characteristics by cohort
| Measure |
Kovacaine Mist 0.1 mL x 4 Sprays
n=10 Participants
Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.
|
Kovacaine Mist 0.2 mL x 2 Sprays
n=10 Participants
Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.
|
Kovacaine Mist, 0.2 mL x 1 Spray
n=10 Participants
Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 12.42 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 9.55 • n=7 Participants
|
54.0 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 12.53 • n=4 Participants
|
|
Gender
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Gender
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (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
|
PRIMARY outcome
Timeframe: at 15 minutes, with +10 minute windowOutcome measures
| Measure |
Kovacaine Mist 0.1 mL x 4 Sprays
n=10 Participants
Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.
|
Kovacaine Mist 0.2 mL x 2 Sprays
n=10 Participants
Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.
|
Kovacaine Mist, 0.2 mL x 1 Spray
n=10 Participants
Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug
|
|---|---|---|---|
|
The Proportion of Subjects Receiving Kovacaine Mist Who do Not Require Rescue Anesthesia During the Operative Dental Procedure
|
10 participants
|
7 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 60 minutesOutcome measures
| Measure |
Kovacaine Mist 0.1 mL x 4 Sprays
n=10 Participants
Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.
|
Kovacaine Mist 0.2 mL x 2 Sprays
n=10 Participants
Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.
|
Kovacaine Mist, 0.2 mL x 1 Spray
n=10 Participants
Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug
|
|---|---|---|---|
|
The Incidence of Subjects Receiving Kovacaine Mist With Changes in Systolic and Diastolic Blood Pressure Exceeding +/- 25% of Preoperative Measurements Values.
Increased systolic BP >25%
|
0 participants
|
1 participants
|
1 participants
|
|
The Incidence of Subjects Receiving Kovacaine Mist With Changes in Systolic and Diastolic Blood Pressure Exceeding +/- 25% of Preoperative Measurements Values.
Decreased systolic BP >25%
|
0 participants
|
0 participants
|
0 participants
|
|
The Incidence of Subjects Receiving Kovacaine Mist With Changes in Systolic and Diastolic Blood Pressure Exceeding +/- 25% of Preoperative Measurements Values.
Increased diastolic BP >25%
|
0 participants
|
0 participants
|
0 participants
|
|
The Incidence of Subjects Receiving Kovacaine Mist With Changes in Systolic and Diastolic Blood Pressure Exceeding +/- 25% of Preoperative Measurements Values.
Decreased diastolic BP >25%
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 60 minutesOutcome measures
| Measure |
Kovacaine Mist 0.1 mL x 4 Sprays
n=10 Participants
Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.
|
Kovacaine Mist 0.2 mL x 2 Sprays
n=10 Participants
Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.
|
Kovacaine Mist, 0.2 mL x 1 Spray
n=10 Participants
Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug
|
|---|---|---|---|
|
The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.
Lower eyelid numb
|
3 participants
|
0 participants
|
0 participants
|
|
The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.
Cheek numb
|
6 participants
|
2 participants
|
1 participants
|
|
The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.
Abnormal sensation tapping front teeth
|
10 participants
|
8 participants
|
5 participants
|
|
The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.
Abnormal sensation in roof of mouth
|
10 participants
|
6 participants
|
7 participants
|
|
The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.
Lip numb
|
6 participants
|
5 participants
|
3 participants
|
|
The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.
Side of nose numb
|
9 participants
|
5 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 60 minutes post drug administrationNumber of patients with an abnormal naris examination finding.
Outcome measures
| Measure |
Kovacaine Mist 0.1 mL x 4 Sprays
n=10 Participants
Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.
|
Kovacaine Mist 0.2 mL x 2 Sprays
n=10 Participants
Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.
|
Kovacaine Mist, 0.2 mL x 1 Spray
n=10 Participants
Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug
|
|---|---|---|---|
|
Naris Examination
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Kovacaine Mist 0.1 mL x 4 Sprays
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Kovacaine Mist 0.2 mL x 2 Sprays
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Kovacaine Mist, 0.2 mL x 1 Spray
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Kovacaine Mist 0.1 mL x 4 Sprays
n=10 participants at risk
Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.
|
Kovacaine Mist 0.2 mL x 2 Sprays
n=10 participants at risk
Total dose: 12 mg tetracaine/0.2 mg oxymetazoline
Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.
|
Kovacaine Mist, 0.2 mL x 1 Spray
n=10 participants at risk
Total dose: 6 mg tetracaine/0.1 mg oxymetazoline
Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug
|
|---|---|---|---|
|
Eye disorders
Lacrimation increased
|
0.00%
0/10 • 24 hours post-dosing
|
30.0%
3/10 • 24 hours post-dosing
|
40.0%
4/10 • 24 hours post-dosing
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
1/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
|
General disorders
Adverse drug reaction
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
|
General disorders
Feeling cold
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
|
Investigations
Blood pressure increased
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
|
General disorders
Application site discomfort
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
|
General disorders
Application site pain
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
2/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
2/10 • 24 hours post-dosing
|
20.0%
2/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
30.0%
3/10 • 24 hours post-dosing
|
40.0%
4/10 • 24 hours post-dosing
|
20.0%
2/10 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
30.0%
3/10 • 24 hours post-dosing
|
20.0%
2/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hypoaesthesia
|
20.0%
2/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
10.0%
1/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
20.0%
2/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
70.0%
7/10 • 24 hours post-dosing
|
80.0%
8/10 • 24 hours post-dosing
|
60.0%
6/10 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
10.0%
1/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Intranasal Hypoaesthesia
|
0.00%
0/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
|
General disorders
Injection Site Anaesthesia
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
|
Gastrointestinal disorders
Dental Discomfort
|
0.00%
0/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
|
Injury, poisoning and procedural complications
Post Procedural Discomfort
|
0.00%
0/10 • 24 hours post-dosing
|
10.0%
1/10 • 24 hours post-dosing
|
0.00%
0/10 • 24 hours post-dosing
|
Additional Information
Christina Sletten, DDS
Rock Dental Clinic
Phone: 719-599-9700
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place