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

A Phase III, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Tetracaine Alone and to Placebo for Anesthetizing Maxillary Teeth in Adults

The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

Study Overview

• Status: Terminated
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05%; Drug: Tetracaine HCl 3%; Drug: Placebo

Detailed Description

The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure.

A total of 140 subjects, randomized 2:2:1 (Kovacaine Mist:Tetracaine alone:Placebo) will be enrolled to achieve 125 completed subjects; a total of 50 Kovacaine Mist subjects, 50 tetracaine alone subjects and 25 placebo subjects. Recruitment will be from diverse dental patient populations. At the two study sites, a balanced enrollment of 70 subjects each is planned to allow for a potential 10% drop-out rate.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 20740
      • University of Maryland, Baltimore
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research
    • Salt Lake City, Utah, United States, 84124
      • Family and Cosmetic Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kovacaine Mist, 3 sprays unilateral; Tetracaine HCl 3% and oxymetazoline HCl 0.05%	Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05%; 3 unilateral intranasal sprays per dose; Other Names: Kovacaine Mist
Experimental: Tetracaine Only, 3 sprays unilateral; Tetracaine HCl 3%	Drug: Tetracaine HCl 3%; 3 unilateral intranasal sprays per dose
Placebo Comparator: Placebo, 3 sprays unilateral; Placebo	Drug: Placebo; 3 unilateral intranasal sprays per dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no).	at 15 minutes with a 3 minute window

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoral Soft-tissue Anesthesia (Yes/no)	Number of patients who reported no pain when incisive papilla and greater palatine foramen soft-tissue was tested with a probe	at 15 minutes with a 3 minute window
Number of Participants With Heart Rate Higher Than 125 Bpm		at any time within 120 minutes following drug administration
Number of Participants With Heart Rate Lower Than 50 Bpm		at any time within 120 minutes following drug administration
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		at any time within 120 minutes following drug administration
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		at any time within 120 minutes following drug administration
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 90 mm Hg		at any time within 120 minutes following drug administration
Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg		at any time within 120 minutes following drug administration
Absolute Maximum Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure		from baseline to 120 minutes following drug administration
The Profile Over Time of Heart Rate		from baseline to 120 minutes following drug administration
Alcohol Sniff Test	The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of an alcohol swab.	administered at approximately 24 hours after drug administration
The Profile Over Time of Systolic Blood Pressure		from baseline to 120 minutes following drug administration
The Profile Over Time of Diastolic Blood Pressure		from baseline to 120 minutes following drug administration
Absolute Maximum Change From Baseline in Heart Rate		from baseline to 120 minutes following drug administration

Collaborators and Investigators

• Sponsor: St. Renatus, LLC
• Collaborators: Rho, Inc.; Triligent International

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: August 2, 2012
• First Submitted That Met QC Criteria: August 8, 2012
• First Posted (Estimate): August 9, 2012

Study Record Updates

• Last Update Posted (Actual): September 5, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: operative; dental procedure
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Anesthetics, Local; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Phenylephrine; Oxymetazoline; Tetracaine
• Other Study ID Numbers: SR 3-01