Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Adults

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745380
• Other study ID #: SR 3-03
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2012
• Last updated: May 15, 2015
• Start date: February 2013
• Est. completion date: May 2013

Study information

• Verified date: May 2015
• Source: St. Renatus, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

• Placebo

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	Center for Dental Research Loma Linda University School	Loma Linda	California
United States	University of Pennsylvania, School of Dental Medicine	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
St. Renatus, LLC	Rho, Inc., Triligent International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Completion of the Study Dental Procedure without need for rescue by injection of local anesthetic (yes/no) when three intranasal sprays are used.		at 25 minutes, +3 minute window	No
Primary	Completion of the Study Dental Procedure without need for rescue by injection of local anesthetic (yes/no) when two intranasal sprays are used.		at 15 minutes, +3 minute window	No
Secondary	Completion of the Study Dental Procedure without need for rescue by injection of local anesthetic (yes/no) by age group (=50 and >50 years)		at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used	No
Secondary	Heart Rate higher than 125 bpm		at any time within 120 minutes following drug administration	Yes
Secondary	Heart Rate lower than 50 bpm		at any time within 120 minutes following drug administration	Yes
Secondary	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		at any time within 120 minutes following drug administration	Yes
Secondary	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		at any time within 120 minutes following study drug administration	Yes
Secondary	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		at any time within 120 minutes following study drug administration	Yes
Secondary	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		at any time within 120 minutes following study drug administration	Yes
Secondary	Maximum change from baseline in Heart Rate, Systolic blood pressure and Diastolic blood pressure		from baseline to 120 minutes following drug administration	Yes
Secondary	The profile over time of Heart Rate, Systolic blood pressure and Diastolic blood pressure		from baseline to 120 minutes following drug administration	Yes
Secondary	Alcohol Sniff Test		administered at approximately 24 hours after drug administration	Yes