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

Anesthesia Clinical Trial

Official title:

Phase 1, Randomized, Double-Blind, Placebo-Controlled, 4-Period, Complete Cross-Over Comparison of the Anesthetic Efficacy of Bilateral and Unilateral Application of Kovacaine Mist in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457806
• Other study ID #: SR 2-04
• Status: Completed
• Phase: Phase 1
• First received: May 21, 2015
• Last updated: November 8, 2016
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2016
• Source: St. Renatus, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Qualified and consenting healthy subjects will be randomly assigned in a double-blind manner to sequences of four randomly ordered study periods with inter-treatment "washout" periods of 3 to 14 days. The four study regimens, which will be applied in random order will be:

• Regimen1. Three sprays of Kovacaine Mist in each nostril (bilateral dosing);

• Regimen 2. Three sprays of Kovacaine Mist in the right nostril and three sprays of placebo in the left nostril (right-sided unilateral dosing);

• Regimen 3. Three sprays of Kovacaine Mist in the left nostril and three sprays of placebo in the right nostril (left-sided unilateral dosing);

• Regimen 4. Three sprays of placebo in each nostril (placebo dosing).

During each testing period, eight representative maxillary teeth (#s 3, 4, 6, 8, 9, 11, 13 and 14) will be assessed for anesthesia using standard EPT testing. EPT testing will be conducted on the eight representative teeth at the following time points (minutes relative to the first spray of study drug): T-5, T3, T7, T11, T16, T21, T26T31, T41, T51, T61, T76, T91, T121, T151, and T181. If EPT testing of a target tooth is not possible (e.g., missing or does not meet inclusion criterion #2) tooth substitution is permissible. For molar teeth, #2 may replace #3 and #15 may replace #14. For premolar teeth, #5 may replace #4 and #12 may replace #13. The same replacements will be made for all testing sessions, and the actual teeth tested will be documented in the CRF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Active Spray with deliverable volume of 0.1 mL
• Placebo spray
Aqueous solution to deliver 0.1 mL per unit

Locations

Country	Name	City	State
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
St. Renatus, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of GPPA for bilateral versus placebo administration		20 minutes of final spray	No
Secondary	Incidence of PPA for individual teeth	For all individually EPT-tested teeth the incidence of Profound Pulpal Anesthesia (PPA) defined as reaching an EPT of 80 within 20 minutes, with unilateral and bilateral drug administration	181 minutes	No
Secondary	Time to onset and duration of PPA	For all individually EPT-tested teeth achieving PPA, time to onset and duration of PPA for unilateral and bilateral drug administration	181 minutes	No
Secondary	Mean highest EPT value reached for first molars (#3 and 14)		181 minutes	No
Secondary	Incidence of induction of PPA following the first, second and third doses of active drug administered unilaterally and bilaterally		181 minutes	No
Secondary	Correlation between positive responses on Subjective Numbness Assessment (DNA) and incidence of global EPT scores of 80		181 minutes	No
Secondary	Systolic Blood Pressure		181 minutes	Yes
Secondary	Diastolic Blood Pressure		181 minutes	Yes
Secondary	Heart Rate		181 minutes	Yes
Secondary	Adverse experiences spontaneously reported	Adverse experiences spontaneously reported by subjects, or observed by study personnel including those encountered on nasal and airway examination (NAE), incidence rates for systolic and diastolic blood pressure and heart rate exceeding +/- 25% of pre-study values	24 hours	Yes