Comparison of Intranasal Kovacaine Mist, Tetracaine Alone... | NCT01710787

Status Module

Name	Class
Triligent International	INDUSTRY
Rho, Inc.	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kovacaine Mist, 3 sprays unilateral	Experimental	Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine Only, 3 sprays unilateral	Experimental	Tetracaine HCl 3%	Drug: Tetracaine HCl 3%
Placebo, 3 sprays unilateral	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%	Drug	3 unilateral intranasal sprays per dose	Kovacaine Mist, 3 sprays unilateral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic.	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.	at 15 minutes with a 3 minute window

Secondary Outcomes

Measure	Description	Time Frame
Intraoral Soft-tissue Anesthesia (Yes/no)	Number of patients who reported no pain when incisive papilla soft-tissue was tested with a probe at designated timepoints	at Baseline, 15, 30, 45, 60, 90, and 120 minutes with a 3 minute window
Number of Participants With a Heart Rate Higher Than 125 Bpm

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female 18 years of age or older.
Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (other than a maxillary first, second, or third molar) with no evidence of pulpal pathology.
Normal lip, nose, eyelid, and cheek sensation.
Able to understand and sign the study informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol.
Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.
Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive.

Exclusion Criteria:

Inadequately controlled hypertension (blood pressure greater than 140/90 mm Hg).
Inadequately controlled active thyroid disease of any type.
Frequent nose bleeds (≥ 5 per month).
Having received dental care requiring a local anesthetic within the last 24 hours.
History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives.
Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
Having received any investigational drug and/or participation in any clinical trial within 30 days prior to study participation.
Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.
History of congenital or idiopathic methemoglobinemia

Name	Affiliation	Role
Paul A. Moore, DMD/PhD/MPH	University of Pittsburgh	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Buffalo		Buffalo	New York	14214-8004	United States
Family and Cosmetic Dentistry

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26892312	Derived	Ciancio SG, Marberger AD, Ayoub F, Garlapo DA, Pantera EA Jr, Pantera CT, Al-Mubarak S, Sobieraj BD, He DY, Myneni SR. Comparison of 3 intranasal mists for anesthetizing maxillary teeth in adults: A randomized, double-masked, multicenter phase 3 clinical trial. J Am Dent Assoc. 2016 May;147(5):339-347.e1. doi: 10.1016/j.adaj.2015.11.009. Epub 2016 Feb 15.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001	Tetracaine Only, 3 Sprays Unilateral

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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
BG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
BG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00044 BG00144 BG00222 BG003110

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic.

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.

Posted

Number

95% Confidence Interval

percentage of patients

at 15 minutes with a 3 minute window

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts
Participants	OG00044 OG00144 OG00222

Title

Denominators

Categories

Title	Measurements
	OG00084.1(69.9 to 93.4) OG00127.3(15 to 42.8) OG00227.3(10.7 to 50.2)

Secondary

Intraoral Soft-tissue Anesthesia (Yes/no)

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

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts

Secondary

Number of Participants With a Heart Rate Higher Than 125 Bpm

Posted

Count of Participants

Participants

at any time within 120 minutes following drug administration

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts
Participants	OG000

Secondary

Number of Participants With a Heart Rate Lower Than 50 Bpm

Posted

Count of Participants

Participants

at any time within 120 minutes following drug administration

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts
Participants	OG000

Secondary

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

Posted

Count of Participants

Participants

at any time within 120 minutes following drug administration

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts
Participants	OG000

Secondary

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

Posted

Count of Participants

Participants

at any time within 120 minutes following drug administration

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts
Participants	OG000

Secondary

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

Posted

Count of Participants

Participants

at any time within 120 minutes following drug administration

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts
Participants	OG000

Secondary

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

Posted

Number

participants

at any time within 120 minutes following drug administration

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts
Participants	OG000

Secondary

Absolute Maximum Change From Baseline in Heart Rate

Posted

Mean

Standard Deviation

bpm

from baseline to 120 minutes following drug administration

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts
Participants	OG000

Secondary

Absolute Maximum Change From Baseline in Systolic Blood Pressure

Posted

Mean

Standard Deviation

mm Hg

from baseline to 120 minutes following drug administration

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts
Participants	OG000

Secondary

Absolute Maximum Change From Baseline in Diastolic Blood Pressure

Posted

Mean

Standard Deviation

mmHg

from baseline to 120 minutes following drug administration

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts
Participants	OG000

Secondary

The Profile Over Time of Heart Rate

Posted

Mean

Standard Deviation

beats per minute

from baseline to 120 minutes following drug administration

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts
Participants	OG000

Secondary

The Profile Over Time of Systolic Blood Pressure

Posted

Mean

Standard Deviation

mmHg

from baseline to 120 minutes following drug administration

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts
Participants	OG000

Secondary

The Profile Over Time of Diastolic Blood Pressure

Posted

Mean

Standard Deviation

mmHg

from baseline to 120 minutes following drug administration

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts
Participants	OG000

Secondary

Alcohol Sniff Test

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

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Units	Counts
Participants	OG000

Secondary

Intraoral Soft-tissue Anesthesia (Onset and Duration)

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

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.

Posted

Mean

Standard Deviation

minutes

up to 120 mins post-dose

ID	Title	Description
OG000	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
OG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
OG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	44	42	44
EG001	Tetracaine Only, 3 Sprays Unilateral	Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose	1	44	44	44
EG002	Placebo, 3 Sprays Unilateral	Placebo Placebo: 3 unilateral intranasal sprays per dose	0	22	11	22

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cellulitis Orbital	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected22 at risk
Headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected22 at risk
Sinusitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected44 at risk EG0011 affected44 at risk EG0020 affected22 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	(runny nose)	EG00017 affected44 at risk EG00116 affected44 at risk EG0020 affected22 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment		EG00015 affected44 at risk EG00127 affected44 at risk EG0023 affected22 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment		EG00010 affected44 at risk EG0015 affected44 at risk EG0021 affected22 at risk
Pharyngeal hypoaesthesia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	(throat numbness)	EG0007 affected44 at risk EG0018 affected44 at risk EG0020 affected22 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment		EG0006 affected44 at risk EG0014 affected44 at risk EG0020 affected22 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment		EG0004 affected44 at risk EG0011 affected44 at risk EG0020 affected22 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment		EG0004 affected44 at risk EG0011 affected44 at risk EG0020 affected22 at risk
Headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment		EG0006 affected44 at risk EG0011 affected44 at risk EG0021 affected22 at risk
Lacrimation increased	Eye disorders	MedDRA 15.0	Systematic Assessment	(tearing or watery eyes)	EG0007 affected44 at risk EG0014 affected44 at risk EG0020 affected22 at risk
Hypertension	Vascular disorders	MedDRA 15.0	Systematic Assessment		EG0004 affected44 at risk EG0011 affected44 at risk EG0021 affected22 at risk
Intranasal Hypoaesthesia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment		EG0007 affected44 at risk EG0015 affected44 at risk EG0022 affected22 at risk
Toothache	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	(Dental Pain, usually attributed to insufficient anesthesia)	EG0002 affected44 at risk EG00110 affected44 at risk EG0025 affected22 at risk
Bradycardia	Cardiac disorders	MedDRA 15.0	Systematic Assessment		EG0004 affected44 at risk EG0012 affected44 at risk EG0021 affected22 at risk
Tachycardia	Cardiac disorders	MedDRA 15.0	Systematic Assessment		EG0003 affected44 at risk EG0012 affected44 at risk EG0020 affected22 at risk

ID	Term
D062366	para-Aminobenzoates
D062365	Aminobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons