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

NCT01844830 | Completed Phase 3 Results

• 1 other identifier: SR 3-04
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Anesthesia

Keywords

operative; dental procedure

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.

  If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.

  100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window

Secondary Outcomes (11)

• Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.by Dosage Cohort.

  100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window

• Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. by Age Group (3-5, 6-11, and 12-17 Years Old, Inclusive).

  100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window

• Incidence of Adverse Events (AEs) by Dosage Cohort

  from baseline to 24 hours following drug administration

• Incidence of Adverse Events (AEs) by Age Group

  from baseline to 24 hours following drug administration

• Results of Naris Examination (NE) - Patency and Ulcerations

  120 minutes post drug administration

Study Arms (2)

Kovacaine Mist

EXPERIMENTAL

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);

Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Placebo

PLACEBO COMPARATOR

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);

Drug: Placebo

Interventions

Tetracaine HCl 3% and Oxymetazoline HCl 0.05% DRUG

Intranasally administered regional anesthetic

Also known as: Kovacaine Mist

Kovacaine Mist

Placebo DRUG

Inactive ingredients supplied in identical nasal sprayer

Also known as: Intranasal administration of inactive ingredients

Placebo

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Renatus, LLC: lead
• Triligent International: collaborator
• Rho, Inc.: collaborator

Study Sites (2)

Center for Dental Research Loma Linda University School

Loma Linda, California, 92350, United States

Location

Big Grins

Fort Collins, Colorado, 80525, United States

Location

MeSH Terms

Interventions

Tetracaine

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Yiming Li, DDS
• Organization: Loma Linda University

kkellingsworth@llu.edu

909-558-4600

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 1, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 30, 2017
• Results First Posted: August 30, 2017

Record last verified: 2017-07

Locations

US (2)