Open-Label Study to Evaluate The Efficacy And Recommended Dosing Regimen Of Kovacaine Mist Administered Unilaterally For Anesthetizing Maxillary Teeth - Full Text View

Purpose

The purpose of this study is to evaluate the efficacy of and recommended dosing regimen for unilateral administration of Kovacaine Mist in inducing pulpal anesthesia of the maxillary teeth for dental procedures.

Condition	Intervention	Phase
Anesthesia	Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05% Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05%	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	A Phase II, Single-Site, Open-Label Clinical Trial To Evaluate The Efficacy And Recommended Dosing Regimen Of Kovacaine Mist Administered Unilaterally For Anesthetizing Maxillary Teeth In Healthy Dental Patients

Resource links provided by NLM:

MedlinePlus related topics: Dental Health

Drug Information available for: Phenylephrine Phenylephrine hydrochloride Tetracaine Tetracaine hydrochloride Oxymetazoline Oxymetazoline hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Cohort 1: The proportion of subjects receiving Kovacaine Mist who do not require rescue anesthesia during the operative dental procedure performed on a tooth in the range of 4 to 13. [ Time Frame: at 15 minutes, with +10 minute window ] [ Designated as safety issue: No ]
Cohort 1: The proportion of subjects receiving Kovacaine Mist who do not require rescue anesthesia during the operative dental procedure performed on tooth 3 or 14. [ Time Frame: 15 minutes, with +10 minute window ] [ Designated as safety issue: No ]
Cohort 2&3: The proportion of subjects receiving Kovacaine Mist who do not require rescue anesthesia during the operative dental procedure performed on a tooth in the range of 4 to 13. [ Time Frame: at 10 minutes, with +5 minute window ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The incidence of subjects receiving Kovacaine Mist with changes in systolic and diastolic blood pressure exceeding +/- 25% of preoperative measurements values. [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
The incidence of subjects receiving Kovacaine Mist with adverse changes in the naris airway. [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
The incidence of minor expected drug reactions after administration of Kovacaine Mist. [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
The proportion of subjects giving a positive response to evaluation question for subjective numbness assessment (SNA) after the procedure is completed. [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2012

Arms	Assigned Interventions
Experimental: Kovacaine Mist, 4 sprays unilateral	Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05% Nasal spray with 0.1 mL per spray. Dose = 4 sprays of study drug per subject delivered at 4-minute intervals.
Experimental: Kovacaine Mist, 2 sprays unilateral	Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05% Nasal spray with 0.2 mL per spray. Dose = 2 sprays of study drug per subject delivered at 4-minute intervals.
Experimental: Kovacaine Mist, 1 spray unilateral	Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05% Nasal spray with 0.2 mL per spray. Dose = 1 spray of study drug per subject.

Detailed Description:

This is a Phase II single-center, open-label clinical trial with three dosing regimens, designed to determine the efficacy and optimal dose of the Kovacaine Mist intranasal delivery system for inducing pulpal anesthesia of maxillary teeth numbers 4-13 (maxillary right second premolar to maxillary left second premolar). Kovacaine will be administered intranasally on the same side of the midline as the tooth on which the procedure will be performed in three dosing cohorts [four 100 μL, two 200 μL, or one 200 μL spray(s)] of 10 subjects each. The first cohort receiving 4 sprays will be completed before initiating study of the remaining two cohorts, which will be treated using a randomized, parallel-group design. Administration: Subjects in the 4- and 2-spray cohorts will be administered the same total dose of 12 mg tetracaine HCl/0.2 mg oxymetazoline HCl. The 4-spray cohort will be treated with a sequence of four 100-μL sprays at intervals of 4 minutes. The 2-spray cohort will be treated with a sequence of two 200 μL sprays 4 minutes apart. The 1-spray cohort will be administered one 200 μL spray, a total dose of 6 mg tetracaine HCl/0.1 mg oxymetazoline HCl, which is half the dose of the 2-spray cohort. Rescue: If the study drug does not provide sufficient anesthesia to allow for completion of the dental procedure, a rescue injection of articaine will be administered.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female subjects who are 18 years of age or older;
requiring an operative restorative procedure on a single maxillary tooth with no evidence of pulpal pathology requiring local anesthesia;
having normal lip, nose, eyelid, and cheek sensations;
able to understand and sign the informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol;
having patency of naris on same side of head as tooth requiring the dental procedure.

Exclusion Criteria:

Inadequately controlled hypertension (blood pressures greater than 150/90) or untreated coronary heart disease;
inadequately controlled thyroid disease including Hashimoto's thyroiditis and partial thyroidectomy;
having frequent nose bleeds (10 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, benzocaine, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreens);
history of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives; history of taking a monoamine oxidase inhibitor within the past 3 weeks;
are nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females will be required to take a urine pregnancy test on the day of but prior to study drug administration to rule out pregnancy);
having used any investigational drug and/or participated in any clinical research trial within 30 days of baseline
enlarged prostate
narrow angle glaucoma
use of oxymetazoline or phenylephrine nasal spray or oral decongestant on the day of the study
congenital or idiopathic methemoglobinemia
diabetes mellitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479517

Locations

United States, Colorado
Rock Dental Clinic
Colorado Springs, Colorado, United States, 80919

Sponsors and Collaborators

St. Renatus, LLC

Investigators

Principal Investigator:

Christina Sletten, DDS

Rock Dental Clinic

More Information

No publications provided

Responsible Party:	St. Renatus, LLC
ClinicalTrials.gov Identifier:	NCT01479517 History of Changes
Other Study ID Numbers:	SR 2-05
Study First Received:	November 22, 2011
Last Updated:	April 24, 2012
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
Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents
Mydriatics
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013