Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Adults - Full Text View

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 adults.

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 Adults

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:

Completion of the Study Dental Procedure without need for rescue by injection of local anesthetic (yes/no) when two intranasal sprays are used. [ Time Frame: at 15 minutes, +3 minute window ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Completion of the Study Dental Procedure without need for rescue by injection of local anesthetic (yes/no) by age group (≤50 and >50 years) [ Time Frame: at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used ] [ Designated as safety issue: No ]
Heart Rate higher than 125 bpm [ Time Frame: at any time within 120 minutes following drug administration ] [ Designated as safety issue: Yes ]
Heart Rate lower than 50 bpm [ Time Frame: at any time within 120 minutes following drug administration ] [ Designated as safety issue: Yes ]
Increase from baseline in Systolic blood pressure greater than or equal to 25 mm Hg and/or to a value higher than 160 mm Hg [ Time Frame: at any time within 120 minutes following drug administration ] [ Designated as safety issue: Yes ]
Decrease from baseline in Systolic blood pressure greater than or equal to 15 mm Hg and/or to a value lower than 90 mm Hg [ Time Frame: at any time within 120 minutes following study drug administration ] [ Designated as safety issue: Yes ]
Increase from baseline in Diastolic blood pressure greater than or equal to 15 mm Hg and/or to a value higher than 105 mm Hg [ Time Frame: at any time within 120 minutes following study drug administration ] [ Designated as safety issue: Yes ]
Decrease from baseline in Diastolic blood pressure greater than or equal to 10 mm Hg and/or to a value lower than 50 mm Hg [ Time Frame: at any time within 120 minutes following study drug administration ] [ Designated as safety issue: Yes ]
Maximum change from baseline in Heart Rate, Systolic blood pressure and Diastolic blood pressure [ Time Frame: from baseline to 120 minutes following drug administration ] [ Designated as safety issue: Yes ]
The profile over time of Heart Rate, Systolic blood pressure and Diastolic blood pressure [ Time Frame: from baseline to 120 minutes following drug administration ] [ Designated as safety issue: Yes ]
Alcohol Sniff Test [ Time Frame: administered at approximately 24 hours after drug administration ] [ Designated as safety issue: Yes ]

Other Outcome Measures:

Completion of the Study Dental Procedure without need for rescue by injection of local anesthetic (yes/no) when three intranasal sprays are used. [ Time Frame: at 25 minutes, +3 minute window ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	February 2013
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Kovacaine Mist Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.	Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% Other Name: Kovacaine Mist
Placebo Comparator: Placebo Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.	Drug: Placebo

Detailed Description:

The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure. The maxillary teeth will be categorized in two subsets, anteriors (teeth numbers 6 to 11) and premolars (teeth numbers 4, 5, 12 and 13).

The intent is to treat 150 subjects at 3 study sites, 2:1 randomization within each study site, and an overall goal of 100 subjects treated with Kovacaine Mist and 50 treated with placebo. Recruitment will be from diverse dental patient populations with at least 25% of subjects over 50 years of age. Randomization will be within strata defined by age (≤50 and >50 years).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female 18 years of age or older.
Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (anterior or premolar tooth #4 to #13) with no evidence of pulpal pathology.
Normal lip, nose, eyelid, and cheek sensation.
Able to understand and sign the study informed consent document, communicate with the Investigators, and understand and comply with the requirements of the protocol.
Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure (the treatment tooth).
Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
Seated systolic blood pressure (SBP) between 95 and 150 mm Hg, inclusive, and seated diastolic blood pressure (DBP) between 60 and 100 mm Hg, inclusive.

Exclusion Criteria:

Inadequately controlled hypertension (blood pressure greater than 150/100 mm Hg).
Inadequately controlled active thyroid disease of any type.
Frequent nose bleeds (≥ 5 per month).
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 articaine, 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 take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
Having received any investigational drug and/or participation in any clinical trial within the 30 days prior to study participation.
History of congenital or idiopathic methemoglobinemia.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745380

Contacts

Contact: Jim Mulvahill

9702820156 ext 26

jmulvahill@st-renatus.com

Locations

United States, California
Center for Dental Research Loma Linda University School	Recruiting
Loma Linda, California, United States, 92350
Contact: Yiming Li, DDS,MDS,PhD 909-558-8069 yli@llu.edu
Principal Investigator: Yiming Li, DDS,MSD,PhD
United States, Maryland
University of Maryland, Baltimore	Recruiting
Baltimore, Maryland, United States, 20740
Contact: Sharon M Gordon, DDS,MPH,PhD 410-706-1656 PainFree@umaryland.edu
Principal Investigator: Sharon M. Gordon, DDS/MPH/PhD
United States, Pennsylvania
University of Pennsylvania, School of Dental Medicine	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elliot V Hersh, DMD,MS,PhD 215-898-9686 evhersh@pobox.upenn.edu
Principal Investigator: Elliot V Hersh, DMD/MS/Ph.D

Sponsors and Collaborators

St. Renatus, LLC

Triligent International

Tegra Analytics

More Information

No publications provided

Responsible Party:	St. Renatus, LLC
ClinicalTrials.gov Identifier:	NCT01745380 History of Changes
Other Study ID Numbers:	SR 3-03
Study First Received:	December 4, 2012
Last Updated:	March 5, 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
Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents
Mydriatics
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013