Clinical trial NCT01745380: Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Adults
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Placebo for Anesthetizing Maxillary Teeth in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2012-12-10
Enrollment: 150
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, 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. The maxillary teeth will be categorized in two subsets, anteriors (teeth numbers 6 to 11) and premolars (teeth numbers 4, 5, 12 and 13).

The intent is to treat 150 subjects at 3 study sites, 2:1 randomization within each study site, and an overall goal of 100 subjects treated with Kovacaine Mist and 50 treated with placebo. Recruitment will be from diverse dental patient populations with at least 25% of subjects over 50 years of age. Randomization will be within strata defined by age (≤50 and \>50 years).

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 (anterior or premolar tooth #4 to #13) 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 (the treatment tooth).
* Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
* Seated systolic blood pressure (SBP) between 95 and 150 mm Hg, inclusive, and seated diastolic blood pressure (DBP) between 60 and 100 mm Hg, inclusive.

Exclusion Criteria:

* Inadequately controlled hypertension (blood pressure greater than 150/100 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 24 hours preceding study entry.
* 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 the 30 days prior to study participation.
* History of congenital or idiopathic methemoglobinemia.

Primary outcomes:
measure: Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
timeFrame: at 15 minutes, +3 minute window
Secondary outcomes:
measure: Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years)
timeFrame: at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used
measure: Number of Participants With a Heart Rate Higher Than 125 Bpm
timeFrame: at any time within 120 minutes following drug administration
measure: Number of Participants With a 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/or 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/or to a Value Lower Than 90 mm Hg
timeFrame: at any time within 120 minutes following study drug administration
measure: Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Higher Than 105 mm Hg
timeFrame: at any time within 120 minutes following study drug administration
measure: Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and/or to a Value Lower Than 50 mm Hg
timeFrame: at any time within 120 minutes following study drug administration
measure: Maximum Change From Baseline in Heart Rate
timeFrame: from baseline to 120 minutes following drug administration
measure: Maximum Change From Baseline in Systolic Blood Pressure
timeFrame: from baseline to 120 minutes following drug administration
measure: Maximum Change From Baseline in 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
Other outcomes:
measure: Number of Participants Who Received Three Sprays and Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
timeFrame: at 25 minutes, +3 minute window
Locations:
city: Loma Linda
country: United States
facility: Center for Dental Research Loma Linda University School
state: California
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Philadelphia
country: United States
facility: University of Pennsylvania, School of Dental Medicine
state: Pennsylvania
Study officials:
References: