Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Adults

NCT01745380 | Completed Phase 3 Results

• 1 other identifier: SR 3-03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Anesthesia

Keywords

operative; dental procedure

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.

  If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.

  at 15 minutes, +3 minute window

Secondary Outcomes (14)

• Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years)

  at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used

• Number of Participants With a Heart Rate Higher Than 125 Bpm

  at any time within 120 minutes following drug administration

• Number of Participants With a 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/or 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/or to a Value Lower Than 90 mm Hg

  at any time within 120 minutes following study drug administration

Other Outcomes (1)

• Number of Participants Who Received Three Sprays and Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.

  at 25 minutes, +3 minute window

Study Arms (2)

Kovacaine Mist

EXPERIMENTAL

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%

Placebo

PLACEBO COMPARATOR

Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.

Drug: Placebo

Interventions

Tetracaine HCl 3% and Oxymetazoline HCl 0.05% DRUG

The study drug is regional anesthetic delivered intranasally on the same side as the operative tooth

Also known as: Kovacaine Mist

Kovacaine Mist

Placebo DRUG

The placebo spray was identical in appearance to and was administered in the same volume and manner as the active ingredient.

Also known as: inactive ingredients

Placebo

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 (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Center for Dental Research Loma Linda University School

Loma Linda, California, 92350, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 20740, United States

Location

University of Pennsylvania, School of Dental Medicine

Philadelphia, Pennsylvania, 19104, 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: Elliott V. Hersh, Principal Investigator
• Organization: University of Pennsylvania School of Dental Medicine

evhersh@pobox.upenn.edu

215-898-9686

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: December 4, 2012
• First Posted: December 10, 2012
• Study Start: February 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 31, 2017
• Results First Posted: January 31, 2017

Record last verified: 2016-12

Locations

US (3)