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

This study has been completed.
Sponsor:
Collaborators:
Triligent International
Tegra Analytics
Information provided by (Responsible Party):
St. Renatus, LLC
ClinicalTrials.gov Identifier:
NCT01844830
First received: April 29, 2013
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Anesthesia
Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by St. Renatus, LLC:

Primary Outcome Measures:
  • Completion of the Study Dental Procedure without need for rescue by injection of local anesthetic (yes/no). [ Time Frame: 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window ] [ Designated as safety issue: 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


Secondary Outcome Measures:
  • 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 Frame: 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window ] [ Designated as safety issue: 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

  • 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 Frame: 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window ] [ Designated as safety issue: 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

  • Incidence of adverse events (AEs) by dose and age group. [ Time Frame: from baseline to 120 minutes following drug administration ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: May 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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);
Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Other Name: Kovacaine Mist
Placebo Comparator: 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);
Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844830

Locations
United States, California
Center for Dental Research Loma Linda University School
Loma Linda, California, United States, 92350
United States, Colorado
Big Grins
Fort Collins, Colorado, United States, 80525
Sponsors and Collaborators
St. Renatus, LLC
Triligent International
Tegra Analytics
  More Information

No publications provided

Responsible Party: St. Renatus, LLC
ClinicalTrials.gov Identifier: NCT01844830     History of Changes
Other Study ID Numbers: SR 3-04
Study First Received: April 29, 2013
Last Updated: September 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Renatus, LLC:
operative
dental procedure

Additional relevant MeSH terms:
Tetracaine
Oxymetazoline
Phenylephrine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Autonomic Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents
Cardiotonic Agents
Mydriatics
Adrenergic alpha-1 Receptor Agonists
Protective Agents

ClinicalTrials.gov processed this record on August 19, 2014