Clinical trial NCT01660893: Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anesthesia
Keywords: operative
dental procedure
Lead sponsor: St. Renatus, LLC
Sponsor class: INDUSTRY
Collaborators: name: Triligent International
name: Rho, Inc.
First posted: 2012-08-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

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

Primary outcomes:
measure: Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no).
timeFrame: at 15 minutes with a 3 minute window
Secondary outcomes:
measure: Intraoral Soft-tissue Anesthesia (Yes/no)
timeFrame: at 15 minutes with a 3 minute window
measure: Number of Participants With Heart Rate Higher Than 125 Bpm
timeFrame: at any time within 120 minutes following drug administration
measure: Number of Participants With Heart Rate Lower Than 50 Bpm
timeFrame: at any time within 120 minutes following drug administration
measure: 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
timeFrame: at any time within 120 minutes following drug administration
measure: 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
timeFrame: at any time within 120 minutes following drug administration
measure: 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
timeFrame: at any time within 120 minutes following drug administration
measure: 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
timeFrame: at any time within 120 minutes following drug administration
measure: Absolute Maximum Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
timeFrame: from baseline to 120 minutes following drug administration
measure: The Profile Over Time of Heart Rate
timeFrame: from baseline to 120 minutes following drug administration
measure: Alcohol Sniff Test
timeFrame: administered at approximately 24 hours after drug administration
measure: The Profile Over Time of Systolic Blood Pressure
timeFrame: from baseline to 120 minutes following drug administration
measure: The Profile Over Time of Diastolic Blood Pressure
timeFrame: from baseline to 120 minutes following drug administration
measure: Absolute Maximum Change From Baseline in Heart Rate
timeFrame: from baseline to 120 minutes following drug administration
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Salt Lake City
country: United States
facility: Family and Cosmetic Dentistry
state: Utah
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: University of Pittsburgh
name: Paul A. Moore, DMD/PhD/MPH
role: STUDY_DIRECTOR
References: