AnesthesiaPhase 2NCT01479517
Open-Label Study of Efficacy and Recommended Dose of Kovacaine Mist for Anesthetizing Maxillary Teeth
A Phase 2 study testing Kovacaine Mist 0.1 mL x 4 sprays, Kovacaine Mist 0.2 mL x 2 sprays and Kovacaine Mist 0.2 mL x 1 spray in people with Anesthesia, run by St. Renatus, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of and recommended dosing regimen for unilateral administration of Kovacaine Mist in inducing pulpal anesthesia of the maxillary teeth for dental procedures. 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?
- Kovacaine Mist 0.1 mL x 4 sprays, Kovacaine Mist 0.2 mL x 2 sprays and Kovacaine Mist 0.2 mL x 1 spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Apr 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 subjects who are 18 years of age or older;
- requiring an operative restorative procedure on a single maxillary tooth with no evidence of pulpal pathology requiring local anesthesia;
- having normal lip, nose, eyelid, and cheek sensations;
- able to understand and sign the informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol;
- having patency of naris on same side of head as tooth requiring the dental procedure.
Who cannot join
- Inadequately controlled hypertension (blood pressures greater than 150/90) or untreated coronary heart disease;
- inadequately controlled thyroid disease including Hashimoto's thyroiditis and partial thyroidectomy;
- having frequent nose bleeds (10 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, benzocaine, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreens);
- history of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives; history of taking a monoamine oxidase inhibitor within the past 3 weeks;
Show all 13Show fewer
- are nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females will be required to take a urine pregnancy test on the day of but prior to study drug administration to rule out pregnancy);
- having used any investigational drug and/or participated in any clinical research trial within 30 days of baseline
- enlarged prostate
- narrow angle glaucoma
- use of oxymetazoline or phenylephrine nasal spray or oral decongestant on the day of the study
- congenital or idiopathic methemoglobinemia
- diabetes mellitus
Trial locations and contacts
1 site in 1 country.
United States1 site
Rock Dental Clinic
Colorado Springs, Colorado, 80919
About this study
Official title: A Phase II, Single-Site, Open-Label Clinical Trial To Evaluate The Efficacy And Recommended Dosing Regimen Of Kovacaine Mist Administered Unilaterally For Anesthetizing Maxillary Teeth In Healthy Dental Patients
The purpose of this study is to evaluate the efficacy of and recommended dosing regimen for unilateral administration of Kovacaine Mist in inducing pulpal anesthesia of the maxillary teeth for dental procedures.
Read the detailed description
This is a Phase II single-center, open-label clinical trial with three dosing regimens, designed to determine the efficacy and optimal dose of the Kovacaine Mist intranasal delivery system for inducing pulpal anesthesia of maxillary teeth numbers 4-13 (maxillary right second premolar to maxillary left second premolar). Kovacaine will be administered intranasally on the same side of the midline as the tooth on which the procedure will be performed in three dosing cohorts [four 100 μL, two 200 μL, or one 200 μL spray(s)] of 10 subjects each. The first cohort receiving 4 sprays will be completed before initiating study of the remaining two cohorts, which will be treated using a randomized, parallel-group design. Administration: Subjects in the 4- and 2-spray cohorts will be administered the same total dose of 12 mg tetracaine HCl/0.2 mg oxymetazoline HCl. The 4-spray cohort will be treated with a sequence of four 100-μL sprays at intervals of 4 minutes. The 2-spray cohort will be treated with a sequence of two 200 μL sprays 4 minutes apart. The 1-spray cohort will be administered one 200 μL spray, a total dose of 6 mg tetracaine HCl/0.1 mg oxymetazoline HCl, which is half the dose of the 2-spray cohort. Rescue: If the study drug does not provide sufficient anesthesia to allow for completion of the dental procedure, a rescue injection of articaine will be administered.
- Conditions
- Anesthesia
- Being tested
- Kovacaine Mist 0.1 mL x 4 sprays, Kovacaine Mist 0.2 mL x 2 sprays, Kovacaine Mist 0.2 mL x 1 spray
- Keywords
- operative, dental procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kovacaine Mist 0.1 mL x 4 spraysDrug
Also called Tetracaine HCl 3% and HCl 0.05%
Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.
Kovacaine Mist 0.2 mL x 2 spraysDrug
Also called Tetracaine HCl 3% and HCl 0.05%
Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.
Kovacaine Mist 0.2 mL x 1 sprayDrug
Also called Tetracaine HCl 3% and HCl 0.05%
Dose = 1 intranasal spray of study drug
| Study group | Role | What they receive |
|---|---|---|
| Kovacaine Mist 0.1 mL x 4 sprays | Experimental | Total dose: 12 mg tetracaine/0.2 mg oxymetazoline Receives: Drug: Kovacaine Mist 0.1 mL x 4 sprays |
| Kovacaine Mist 0.2 mL x 2 sprays | Experimental | Total dose: 12 mg tetracaine/0.2 mg oxymetazoline Receives: Drug: Kovacaine Mist 0.2 mL x 2 sprays |
| Kovacaine Mist, 0.2 mL x 1 spray | Experimental | Total dose: 6 mg tetracaine/0.1 mg oxymetazoline Receives: Drug: Kovacaine Mist 0.2 mL x 1 spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Subjects Receiving Kovacaine Mist Who do Not Require Rescue Anesthesia During the Operative Dental Procedure
Measured: at 15 minutes, with +10 minute window
Secondary outcomes (3)
The Incidence of Subjects Receiving Kovacaine Mist With Changes in Systolic and Diastolic Blood Pressure Exceeding +/- 25% of Preoperative Measurements Values.
Measured: 60 minutes
The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.
Measured: 60 minutes
Naris Examination
Number of patients with an abnormal naris examination finding.
Measured: 60 minutes post drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Renatus, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rho, Inc., Triligent International
- Responsible party
- Sponsor
- Investigators
- Christina Sletten, DDS, Principal investigator, Rock Dental Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479517
- Sponsor's protocol ID
- SR 2-05
- Status last verified
- Nov 2016
- First submitted
- 22 Nov 2011
- Last updated
- 29 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-Site, Open-Label Clinical Trial To Evaluate The Efficacy And Recommended Dosing Regimen Of Kovacaine Mist Administered Unilaterally For Anesthetizing Maxillary Teeth In Healthy Dental Patients
- ClinicalTrials.gov ID
- NCT01479517
- Acronym / sponsor ID
- SR 2-05
- Conditions
- Anesthesia
- Keywords
- operative, dental procedure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St. Renatus, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Rho, Inc., Triligent International
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 24 Nov 2011 (estimated)
- Results
- Posted 29 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of and recommended dosing regimen for unilateral administration of Kovacaine Mist in inducing pulpal anesthesia of the maxillary teeth for dental procedures.
Detailed description
This is a Phase II single-center, open-label clinical trial with three dosing regimens, designed to determine the efficacy and optimal dose of the Kovacaine Mist intranasal delivery system for inducing pulpal anesthesia of maxillary teeth numbers 4-13 (maxillary right second premolar to maxillary left second premolar). Kovacaine will be administered intranasally on the same side of the midline as the tooth on which the procedure will be performed in three dosing cohorts [four 100 μL, two 200 μL, or one 200 μL spray(s)] of 10 subjects each. The first cohort receiving 4 sprays will be completed before initiating study of the remaining two cohorts, which will be treated using a randomized, parallel-group design. Administration: Subjects in the 4- and 2-spray cohorts will be administered the same total dose of 12 mg tetracaine HCl/0.2 mg oxymetazoline HCl. The 4-spray cohort will be treated with a sequence of four 100-μL sprays at intervals of 4 minutes. The 2-spray cohort will be treated with a sequence of two 200 μL sprays 4 minutes apart. The 1-spray cohort will be administered one 200 μL spray, a total dose of 6 mg tetracaine HCl/0.1 mg oxymetazoline HCl, which is half the dose of the 2-spray cohort. Rescue: If the study drug does not provide sufficient anesthesia to allow for completion of the dental procedure, a rescue injection of articaine will be administered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kovacaine Mist 0.1 mL x 4 sprays | Experimental | Drug: Kovacaine Mist 0.1 mL x 4 spraysTotal dose: 12 mg tetracaine/0.2 mg oxymetazoline |
| Kovacaine Mist 0.2 mL x 2 sprays | Experimental | Drug: Kovacaine Mist 0.2 mL x 2 spraysTotal dose: 12 mg tetracaine/0.2 mg oxymetazoline |
| Kovacaine Mist, 0.2 mL x 1 spray | Experimental | Drug: Kovacaine Mist 0.2 mL x 1 sprayTotal dose: 6 mg tetracaine/0.1 mg oxymetazoline |
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 subjects who are 18 years of age or older;
- requiring an operative restorative procedure on a single maxillary tooth with no evidence of pulpal pathology requiring local anesthesia;
- having normal lip, nose, eyelid, and cheek sensations;
- able to understand and sign the informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol;
- having patency of naris on same side of head as tooth requiring the dental procedure.
Key exclusion criteria (13 listed)
- Inadequately controlled hypertension (blood pressures greater than 150/90) or untreated coronary heart disease;
- inadequately controlled thyroid disease including Hashimoto's thyroiditis and partial thyroidectomy;
- having frequent nose bleeds (10 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, benzocaine, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreens);
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 |
|---|---|---|
| Kovacaine Mist 0.1 mL x 4 spraysAlso: Tetracaine HCl 3% and HCl 0.05%Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals. | Drug | Kovacaine Mist 0.1 mL x 4 sprays |
| Kovacaine Mist 0.2 mL x 2 spraysAlso: Tetracaine HCl 3% and HCl 0.05%Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals. | Drug | Kovacaine Mist 0.2 mL x 2 sprays |
| Kovacaine Mist 0.2 mL x 1 sprayAlso: Tetracaine HCl 3% and HCl 0.05%Dose = 1 intranasal spray of study drug | Drug | Kovacaine Mist, 0.2 mL x 1 spray |
Primary outcome
The Proportion of Subjects Receiving Kovacaine Mist Who do Not Require Rescue Anesthesia During the Operative Dental Procedure
Time frame: at 15 minutes, with +10 minute window
3 secondary outcomes
The Incidence of Subjects Receiving Kovacaine Mist With Changes in Systolic and Diastolic Blood Pressure Exceeding +/- 25% of Preoperative Measurements Values.
Time frame: 60 minutes
The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.
Time frame: 60 minutes
Naris Examination
Time frame: 60 minutes post drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Christina Sletten, DDS principal investigator
Rock Dental Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kovacaine Mist 0.1 mL x 4 sprays, Kovacaine Mist 0.2 mL x 2 sprays and Kovacaine Mist 0.2 mL x 1 spray 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 13 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 29 Dec 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Proportion of Subjects Receiving Kovacaine Mist Who do Not Require Rescue Anesthesia During the Operative Dental Procedure (time frame: at 15 minutes, with +10 minute window). 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 29 Dec 2016.