- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02457806
Comparison of Anesthetic Efficacy of Bilateral and Unillateral Application of Kovacaine Mist in Healthy Volunteers
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84124
- Jean Brown Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kovacaine Mist
3 sprays of Kovacaine Mist (Tetracaine HCl 3% and Oxymetazoline HCl 0.05%) in each nostril (bilateral dosing) administered 4 minutes apart
|
Active Spray with deliverable volume of 0.1 mL
Other Names:
|
Active Comparator: Kovacaine Mist and Placebo
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
|
Active Spray with deliverable volume of 0.1 mL
Other Names:
Aqueous solution to deliver 0.1 mL per unit
Other Names:
|
Active Comparator: Placebo and Kovacaine Mist
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
|
Active Spray with deliverable volume of 0.1 mL
Other Names:
Aqueous solution to deliver 0.1 mL per unit
Other Names:
|
Placebo Comparator: Placebo spray
3 sprays of placebo in each nostril administered 4 minutes apart
|
Aqueous solution to deliver 0.1 mL per unit
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Achievement of GPPA by teeth reaching an EPT of 80
Time Frame: 20 minutes of final spray
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of GPPA for bilateral versus placebo administration
Time Frame: 20 minutes of final spray
|
20 minutes of final spray
|
|
Incidence of PPA for individual teeth
Time Frame: 181 minutes
|
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
|
Time to onset and duration of PPA
Time Frame: 181 minutes
|
For all individually EPT-tested teeth achieving PPA, time to onset and duration of PPA for unilateral and bilateral drug administration
|
181 minutes
|
Mean highest EPT value reached for first molars (#3 and 14)
Time Frame: 181 minutes
|
181 minutes
|
|
Incidence of induction of PPA following the first, second and third doses of active drug administered unilaterally and bilaterally
Time Frame: 181 minutes
|
181 minutes
|
|
Correlation between positive responses on Subjective Numbness Assessment (DNA) and incidence of global EPT scores of 80
Time Frame: 181 minutes
|
181 minutes
|
|
Systolic Blood Pressure
Time Frame: 181 minutes
|
181 minutes
|
|
Diastolic Blood Pressure
Time Frame: 181 minutes
|
181 minutes
|
|
Heart Rate
Time Frame: 181 minutes
|
181 minutes
|
|
Adverse experiences spontaneously reported
Time Frame: 24 hours
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick R Brain, DDS, Jean Brown Research
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Anesthetics, Local
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Phenylephrine
- Oxymetazoline
- Tetracaine
Other Study ID Numbers
- SR 2-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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