Comparison of Anesthetic Efficacy of Bilateral and Unillateral Application of Kovacaine Mist in Healthy Volunteers

NCT02457806 | Completed Phase 1

• 1 other identifier: SR 2-04
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy of Kovacaine Mist administered bilaterally to that of Kovacaine Mist administered unilaterally with respect to global profound pulpal anesthesia in target teeth numbers 4-13.

Conditions

Anesthesia

Keywords

Dental Anesthesia

Outcome Measures

Primary Outcomes (1)

• Achievement of GPPA by teeth reaching an EPT of 80

  Achievement of Global Profound Pulpal Anesthesia (GPPA) as having all three target maxillary teeth \[nos. 4(or 5), 6, and 8 for the right side or nos. 9, 11, and 13 (or 12) for the left-side\] reach an EPT of 80 within 20 minutes of the final spray of study drug

  20 minutes of final spray

Secondary Outcomes (10)

• Incidence of GPPA for bilateral versus placebo administration

  20 minutes of final spray

• Incidence of PPA for individual teeth

  181 minutes

• Time to onset and duration of PPA

  181 minutes

• Mean highest EPT value reached for first molars (#3 and 14)

  181 minutes

• Incidence of induction of PPA following the first, second and third doses of active drug administered unilaterally and bilaterally

  181 minutes

Study Arms (4)

Kovacaine Mist

EXPERIMENTAL

3 sprays of Kovacaine Mist (Tetracaine HCl 3% and Oxymetazoline HCl 0.05%) in each nostril (bilateral dosing) administered 4 minutes apart

Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Kovacaine Mist and Placebo

ACTIVE COMPARATOR

3 sprays of Kovacaine Mist (Tetracaine HCl 3% and Oxymetazoline HCl 0.05%) in the right nostril and three sprays of placebo in the left nostril (right-sided unilateral dosing) administered 4 minutes apart

Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%; Drug: Placebo spray

Placebo and Kovacaine Mist

ACTIVE COMPARATOR

3 sprays of Kovacaine Mist (Tetracaine HCl 3% and Oxymetazoline HCl 0.05%) in the left nostril and 3 sprays of placebo in the right nostril (left-sided dosing) administered 4 minutes apart

Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%; Drug: Placebo spray

Placebo spray

PLACEBO COMPARATOR

3 sprays of placebo in each nostril administered 4 minutes apart

Drug: Placebo spray

Interventions

Tetracaine HCl 3% and Oxymetazoline HCl 0.05% DRUG

Active Spray with deliverable volume of 0.1 mL

Also known as: Kovacaine Mist

Kovacaine Mist; Kovacaine Mist and Placebo; Placebo and Kovacaine Mist

Placebo spray DRUG

Aqueous solution to deliver 0.1 mL per unit

Also known as: Placebo

Kovacaine Mist and Placebo; Placebo and Kovacaine Mist; Placebo spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18 years of age or older.
• Eight representative maxillary teeth \[(3 (or 2), 4 (or 5), 6, 8, 9, 11, 13 (or 12), and 14 (or15)\] free of observable decay (or other pathology), crowns or veneers, all of which have EPT values of 10-50 at screening.
• Normal lip, nose, eyelid, palate, and cheek sensation.
• Patency of both left and right nasal airways.
• Ability to understand and willingness to sign the study informed consent form, communicate with study investigators, and understand and comply with the requirements of the study protocol.

You may not qualify if:

• Poorly controlled hypertension (blood pressure greater than 150/90 mmHg) or history of coronary heart disease.
• Diabetes mellitus.
• Any active thyroid disease other than S/P thyroidectomy on thyroid hormone replacement with TSH values in the normal range.
• History or presence of narrow-angle glaucoma.
• Prostatic enlargement.
• History of sinus/nasal surgery that, in the opinion of the investigator, could confound study results.
• History of frequent nose bleeds.
• Receipt of 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, succinylcholine, or para-aminobenzoic acid (as found in PABA-containing sunscreens).
• History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite antioxidants.
• History of drug abuse.
• Use of a monoamine oxidase inhibitor within the 3 weeks immediately prior to anticipated study participation.
• Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females will be required to undergo pregnancy testing to rule out pregnancy)
• Use of any investigational drug and/or participation in a clinical research trial within 30 days of the first study dosing day.
• Requirement for uninterrupted use of any medication with actions that might, in the opinion of the involved investigator, confound interpretation of study results.

Sponsors & Collaborators

• St. Renatus, LLC: lead

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, 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

Study Officials

• Patrick R Brain, DDS

  Jean Brown Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: May 29, 2015
• Study Start: August 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

US (1)