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

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 Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844830
• Other study ID #: SR 3-04
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2013
• Last updated: May 27, 2015
• Start date: May 2013
• Est. completion date: July 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 pediatric patients.

Description:

The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to demonstrate the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary permanent teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) or maxillary primary teeth numbers A to J (maxillary right second primary molar to maxillary left second primary molar) sufficient to allow completion of the Study Dental Procedure. The maxillary teeth will be categorized in two subsets, anterior teeth (permanent teeth numbers 6 to 11 and primary teeth numbers C to H) and posterior teeth (permanent teeth numbers 4, 5, 12, 13 and primary teeth numbers A, B, I, J).

The intent is to treat 90 male and female subjects aged 3 to 17 years, inclusive, at 3 study sites, 2:1 randomization within each study site, and an overall goal of 60 subjects treated with Kovacaine Mist and 30 treated with placebo. Subjects will receive Kovacaine Mist or placebo (2:1) according to the kit randomization plan within three dosing strata (100 µL, 200 µL or 400 µL) based on subject weight at entry: subjects weighing 10 to <20 kg, 20 to <40 kg and ≥ 40 kg will be assigned to the 100 µL, 200 µL or 400 µL dose group, respectively. Recruitment will be from diverse pediatric dental patient populations. To ensure adequate representation in the 3 dose/weight groups, each stratum will contain at least 25% of subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

• Male or female 3-17 years of age inclusive.

• Need for an operative restorative dental procedure and requiring local anesthesia on a single vital maxillary primary tooth (#A to J) or permanent tooth (#4 to13), with no evidence of pulpal pathology.

• Normal lip, nose, eyelid, and cheek sensation.

• Accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document.

• Subject able to understand and provide assent to an age-appropriate subject assent form (as defined by local practice or regulation).

• Patient or parent/guardian able to communicate with the investigator and comply with the requirements of the protocol.

• Patency of the naris on the same side as the tooth undergoing the Study Dental Procedure (the Study Treatment Tooth).

Exclusion Criteria:

• 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 lidocaine, 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 undergo urine testing on the day of, but prior to, study drug administration to rule out pregnancy.)

• Inadequately controlled thyroid disease of any type.

• Having received any investigational drug (including Kovacaine Mist) and/or participation in any clinical trial within 30 days of study participation.

• Frequent nose bleeds (= 5 per month).

• History of congenital or idiopathic methemoglobinemia.

• Presence of an upper respiratory infection and/or fever defined as body temperature =100.4° (38°C) on the day of and prior to study drug administration.

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	Big Grins	Fort Collins	Colorado
United States	Center for Dental Research Loma Linda University School	Loma Linda	California

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).	Time of dental procedure: for subjects who receive the 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window	100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - 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 dose (100 µL, 200 µL or 400 µL).	Time of dental procedure: for subjects who receive the 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window	100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - 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 (3-5, 6-11, and 12-17 years old, inclusive).	Time of dental procedure: for subjects who receive the 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window	100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window	No
Secondary	Incidence of adverse events (AEs) by dose and age group.		from baseline to 120 minutes following drug administration	Yes