AnesthesiaPhase 1NCT02457806
Comparison of Anesthetic Efficacy of Bilateral and Unillateral Application of Kovacaine Mist in Healthy Volunteers
A Phase 1 study testing Tetracaine HCl 3% and Oxymetazoline HCl 0.05% in people with Anesthesia, run by St. Renatus, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Tetracaine HCl 3% and Oxymetazoline HCl 0.05%, Placebo spray
- Keywords
- Dental Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%Drug
Also called Kovacaine Mist
Active Spray with deliverable volume of 0.1 mL
Placebo sprayDrug
Also called Placebo
Aqueous solution to deliver 0.1 mL per unit
| Study group | Role | What they receive |
|---|---|---|
| Kovacaine Mist | Experimental | 3 sprays of Kovacaine Mist (Tetracaine HCl 3% and Oxymetazoline HCl 0.05%) in each nostril (bilateral dosing) administered 4 minutes apart Receives: Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% |
| Kovacaine Mist and Placebo | Active comparator | 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 Receives: Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%; Drug: Placebo spray |
| Placebo and Kovacaine Mist | Active comparator | 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 Receives: Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%; Drug: Placebo spray |
| Placebo spray | Placebo comparator | 3 sprays of placebo in each nostril administered 4 minutes apart Receives: Drug: Placebo spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 minutes of final spray
Secondary outcomes (10)
Incidence of GPPA for bilateral versus placebo administration
Measured: 20 minutes of final spray
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
Measured: 181 minutes
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
Measured: 181 minutes
Mean highest EPT value reached for first molars (#3 and 14)
Measured: 181 minutes
Incidence of induction of PPA following the first, second and third doses of active drug administered unilaterally and bilaterally
Measured: 181 minutes
Correlation between positive responses on Subjective Numbness Assessment (DNA) and incidence of global EPT scores of 80
Measured: 181 minutes
Systolic Blood Pressure
Measured: 181 minutes
Diastolic Blood Pressure
Measured: 181 minutes
Heart Rate
Measured: 181 minutes
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Renatus, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick R Brain, DDS, Principal investigator, Jean Brown Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457806
- Sponsor's protocol ID
- SR 2-04
- Status last verified
- Nov 2016
- First submitted
- 21 May 2015
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02457806
- Acronym / sponsor ID
- SR 2-04
- Conditions
- Anesthesia
- Keywords
- Dental Anesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- St. Renatus, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Kovacaine Mist | Experimental | Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%3 sprays of Kovacaine Mist (Tetracaine HCl 3% and Oxymetazoline HCl 0.05%) in each nostril (bilateral dosing) administered 4 minutes apart |
| Kovacaine Mist and Placebo | Active comparator | Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%, Drug: Placebo spray3 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 |
| Placebo and Kovacaine Mist | Active comparator | Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%, Drug: Placebo spray3 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 |
| Placebo spray | Placebo comparator | Drug: Placebo spray3 sprays of placebo in each nostril administered 4 minutes apart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetracaine HCl 3% and Oxymetazoline HCl 0.05%Also: Kovacaine MistActive Spray with deliverable volume of 0.1 mL | Drug | Kovacaine Mist, Kovacaine Mist and Placebo, Placebo and Kovacaine Mist |
| Placebo sprayAlso: PlaceboAqueous solution to deliver 0.1 mL per unit | Drug | Kovacaine Mist and Placebo, Placebo and Kovacaine Mist, Placebo spray |
Primary outcome
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
10 secondary outcomes
Incidence of GPPA for bilateral versus placebo administration
Time frame: 20 minutes of final spray
Incidence of PPA for individual teeth
Time frame: 181 minutes
Time to onset and duration of PPA
Time frame: 181 minutes
Mean highest EPT value reached for first molars (#3 and 14)
Time frame: 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
Correlation between positive responses on Subjective Numbness Assessment (DNA) and incidence of global EPT scores of 80
Time frame: 181 minutes
Systolic Blood Pressure
Time frame: 181 minutes
Diastolic Blood Pressure
Time frame: 181 minutes
Heart Rate
Time frame: 181 minutes
Adverse experiences spontaneously reported
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick R Brain, DDS principal investigator
Jean Brown Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tetracaine HCl 3% and Oxymetazoline HCl 0.05% in people with Anesthesia, run by St. Renatus, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of GPPA by teeth reaching an EPT of 80 (time frame: 20 minutes of final spray). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2016.