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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01660893
• Other study ID #: SR 3-01
• Status: Terminated
• Phase: Phase 3
• First received: August 2, 2012
• Last updated: May 15, 2015
• Start date: August 2012
• Est. completion date: September 2012

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, Tetracaine only, 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• 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 (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 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%
3 unilateral intranasal sprays per dose
• Tetracaine HCl 3%
3 unilateral intranasal sprays per dose
• Placebo
3 unilateral intranasal sprays per dose

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	Family and Cosmetic Dentistry	Salt Lake City	Utah
United States	Jean Brown Research	Salt Lake City	Utah

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
Primary	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	No
Secondary	Intraoral soft-tissue anesthesia (yes/no) and the time to onset and duration of such soft-tissue anesthesia.		at 15 minutes with a 3 minute window	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 to a value higher than 140 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 to a value lower than 90 mm Hg		at any time within 120 minutes following drug administration	Yes
Secondary	Increase from baseline in Diastolic blood pressure greater than or equal to 15 mm Hg and to a value higher than 95 mm Hg		at any time within 120 minutes following drug administration	Yes
Secondary	Decrease from baseline in Diastolic blood pressure greater than or equal to 10 mm Hg and to a value lower than 50 mm Hg		at any time within 120 minutes following 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