Open-Label Study of Efficacy and Recommended Dose of Kovacaine Mist for Anesthetizing Maxillary Teeth

NCT01479517 | Completed Phase 2 Results

• 1 other identifier: SR 2-05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia

Keywords

operative; dental procedure

Outcome Measures

Primary Outcomes (1)

• The Proportion of Subjects Receiving Kovacaine Mist Who do Not Require Rescue Anesthesia During the Operative Dental Procedure

  at 15 minutes, with +10 minute window

Secondary Outcomes (3)

• The Incidence of Subjects Receiving Kovacaine Mist With Changes in Systolic and Diastolic Blood Pressure Exceeding +/- 25% of Preoperative Measurements Values.

  60 minutes

• The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.

  60 minutes

• Naris Examination

  60 minutes post drug administration

Study Arms (3)

Kovacaine Mist 0.1 mL x 4 sprays

EXPERIMENTAL

Total dose: 12 mg tetracaine/0.2 mg oxymetazoline

Drug: Kovacaine Mist 0.1 mL x 4 sprays

Kovacaine Mist 0.2 mL x 2 sprays

EXPERIMENTAL

Total dose: 12 mg tetracaine/0.2 mg oxymetazoline

Drug: Kovacaine Mist 0.2 mL x 2 sprays

Kovacaine Mist, 0.2 mL x 1 spray

EXPERIMENTAL

Total dose: 6 mg tetracaine/0.1 mg oxymetazoline

Drug: Kovacaine Mist 0.2 mL x 1 spray

Interventions

Kovacaine Mist 0.1 mL x 4 sprays DRUG

Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.

Also known as: Tetracaine HCl 3% and HCl 0.05%

Kovacaine Mist 0.1 mL x 4 sprays

Kovacaine Mist 0.2 mL x 2 sprays DRUG

Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.

Also known as: Tetracaine HCl 3% and HCl 0.05%

Kovacaine Mist 0.2 mL x 2 sprays

Kovacaine Mist 0.2 mL x 1 spray DRUG

Dose = 1 intranasal spray of study drug

Also known as: Tetracaine HCl 3% and HCl 0.05%

Kovacaine Mist, 0.2 mL x 1 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Rock Dental Clinic

Colorado Springs, Colorado, 80919, 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: Christina Sletten, DDS
• Organization: Rock Dental Clinic

719-599-9700

Study Officials

• Christina Sletten, DDS

  Rock Dental Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: January 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 29, 2016
• Results First Posted: December 29, 2016

Record last verified: 2016-11

Locations

US (1)