Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth

NCT01660893 | Terminated Phase 3 Results

• 1 other identifier: SR 3-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

Conditions

Anesthesia

Keywords

operative; dental procedure

Outcome Measures

Primary Outcomes (1)

• Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no).

  at 15 minutes with a 3 minute window

Secondary Outcomes (13)

• Intraoral Soft-tissue Anesthesia (Yes/no)

  at 15 minutes with a 3 minute window

• Number of Participants With Heart Rate Higher Than 125 Bpm

  at any time within 120 minutes following drug administration

• Number of Participants With Heart Rate Lower Than 50 Bpm

  at any time within 120 minutes following drug administration

• Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg

  at any time within 120 minutes following drug administration

• Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg

  at any time within 120 minutes following drug administration

Study Arms (3)

Kovacaine Mist, 3 sprays unilateral

EXPERIMENTAL

Tetracaine HCl 3% and oxymetazoline HCl 0.05%

Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05%

Tetracaine Only, 3 sprays unilateral

EXPERIMENTAL

Tetracaine HCl 3%

Drug: Tetracaine HCl 3%

Placebo, 3 sprays unilateral

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Tetracaine HCl 3% and oxymetazoline HCl 0.05% DRUG

3 unilateral intranasal sprays per dose

Also known as: Kovacaine Mist

Kovacaine Mist, 3 sprays unilateral

Tetracaine HCl 3% DRUG

3 unilateral intranasal sprays per dose

Tetracaine Only, 3 sprays unilateral

Placebo DRUG

3 unilateral intranasal sprays per dose

Placebo, 3 sprays unilateral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (other than a maxillary first, second, or third molar) 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.
• Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
• Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive.

You may not qualify if:

• Inadequately controlled hypertension (blood pressure greater than 140/90 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 last 24 hours.
• 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 30 days prior to study participation.
• Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.
• History of congenital or idiopathic methemoglobinemia

Sponsors & Collaborators

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

Study Sites (3)

University of Maryland, Baltimore

Baltimore, Maryland, 20740, United States

Location

Family and Cosmetic Dentistry

Salt Lake City, Utah, 84124, United States

Location

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

Results Point of Contact

• Title: Dr. Sharon M. Gordon
• Organization: University of Maryland

sgordon@dental.umaryland.edu

410-706-1656

Study Officials

• Paul A. Moore, DMD/PhD/MPH

  University of Pittsburgh

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 9, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 5, 2017
• Results First Posted: September 5, 2017

Record last verified: 2017-08

Locations

US (3)