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

NCT ID: NCT01844830

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-07-31

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 pediatric patients.

Detailed 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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Kovacaine Mist

Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);

Group Type: EXPERIMENTAL

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Intervention Type: DRUG

Intranasally administered regional anesthetic

Placebo

Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inactive ingredients supplied in identical nasal sprayer

Interventions

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Intranasally administered regional anesthetic

Intervention Type: DRUG

Placebo

Inactive ingredients supplied in identical nasal sprayer

Intervention Type: DRUG

Other Intervention Names

Kovacaine Mist; Intranasal administration of inactive ingredients

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Triligent International

INDUSTRY

Sponsor Role: collaborator

Rho, Inc.

INDUSTRY

Sponsor Role: collaborator

St. Renatus, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center for Dental Research Loma Linda University School

Loma Linda, California, United States

Big Grins

Fort Collins, Colorado, United States

Countries

United States

Other Identifiers

SR 3-04

Identifier Type: -

Identifier Source: org_study_id