AnesthesiaPhase 3NCT01660893
Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth
A Phase 3 study testing Tetracaine HCl 3% and oxymetazoline HCl 0.05% and Tetracaine HCl 3% in people with Anesthesia, run by St. Renatus, LLC at 3 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Tetracaine HCl 3% and oxymetazoline HCl 0.05% and Tetracaine HCl 3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2012to Sep 2012
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (other than a maxillary first, second, or third molar) 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.
- Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
- Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive.
Who cannot join
- Inadequately controlled hypertension (blood pressure greater than 140/90 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 last 24 hours.
- 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.
Show all 11Show fewer
- 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 30 days prior to study participation.
- Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.
- History of congenital or idiopathic methemoglobinemia
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland, Baltimore
Baltimore, Maryland, 20740
Family and Cosmetic Dentistry
Salt Lake City, Utah, 84124
Jean Brown Research
Salt Lake City, Utah, 84124
About this study
Official title: A Phase III, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Tetracaine Alone and to Placebo for Anesthetizing Maxillary Teeth in Adults
The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.
Read the detailed description
The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure.
A total of 140 subjects, randomized 2:2:1 (Kovacaine Mist:Tetracaine alone:Placebo) will be enrolled to achieve 125 completed subjects; a total of 50 Kovacaine Mist subjects, 50 tetracaine alone subjects and 25 placebo subjects. Recruitment will be from diverse dental patient populations. At the two study sites, a balanced enrollment of 70 subjects each is planned to allow for a potential 10% drop-out rate.
- Conditions
- Anesthesia
- Being tested
- Tetracaine HCl 3% and oxymetazoline HCl 0.05%, Tetracaine HCl 3%, Placebo
- Keywords
- operative, dental procedure
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
3 unilateral intranasal sprays per dose
Tetracaine HCl 3%Drug
3 unilateral intranasal sprays per dose
PlaceboDrug
3 unilateral intranasal sprays per dose
| Study group | Role | What they receive |
|---|---|---|
| Kovacaine Mist, 3 sprays unilateral | Experimental | Tetracaine HCl 3% and oxymetazoline HCl 0.05% Receives: Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05% |
| Tetracaine Only, 3 sprays unilateral | Experimental | Tetracaine HCl 3% Receives: Drug: Tetracaine HCl 3% |
| Placebo, 3 sprays unilateral | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no).
Measured: at 15 minutes with a 3 minute window
Secondary outcomes (13)
Intraoral Soft-tissue Anesthesia (Yes/no)
Number of patients who reported no pain when incisive papilla and greater palatine foramen soft-tissue was tested with a probe
Measured: at 15 minutes with a 3 minute window
Number of Participants With Heart Rate Higher Than 125 Bpm
Measured: at any time within 120 minutes following drug administration
Number of Participants With Heart Rate Lower Than 50 Bpm
Measured: 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 to a Value Higher Than 160 mm Hg
Measured: 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 to a Value Lower Than 90 mm Hg
Measured: at any time within 120 minutes following drug administration
Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 90 mm Hg
Measured: at any time within 120 minutes following drug administration
Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg
Measured: at any time within 120 minutes following drug administration
Absolute Maximum Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Measured: from baseline to 120 minutes following drug administration
The Profile Over Time of Heart Rate
Measured: from baseline to 120 minutes following drug administration
Alcohol Sniff Test
The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of an alcohol swab.
Measured: administered at approximately 24 hours after drug administration
The Profile Over Time of Systolic Blood Pressure
Measured: from baseline to 120 minutes following drug administration
The Profile Over Time of Diastolic Blood Pressure
Measured: from baseline to 120 minutes following drug administration
Absolute Maximum Change From Baseline in Heart Rate
Measured: from baseline to 120 minutes following drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2012
- Study completionSep 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Renatus, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Triligent International, Rho, Inc.
- Responsible party
- Sponsor
- Investigators
- Paul A. Moore, DMD/PhD/MPH, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660893
- Sponsor's protocol ID
- SR 3-01
- Status last verified
- Aug 2017
- First submitted
- 2 Aug 2012
- Last updated
- 5 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Tetracaine Alone and to Placebo for Anesthetizing Maxillary Teeth in Adults
- ClinicalTrials.gov ID
- NCT01660893
- Acronym / sponsor ID
- SR 3-01
- Conditions
- Anesthesia
- Keywords
- operative, dental procedure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 26 participants (actual)
- Lead sponsor
- St. Renatus, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Triligent International, Rho, Inc.
- Study start
- Aug 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Posted 5 Sep 2017
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 compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.
Detailed description
The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure.
A total of 140 subjects, randomized 2:2:1 (Kovacaine Mist:Tetracaine alone:Placebo) will be enrolled to achieve 125 completed subjects; a total of 50 Kovacaine Mist subjects, 50 tetracaine alone subjects and 25 placebo subjects. Recruitment will be from diverse dental patient populations. At the two study sites, a balanced enrollment of 70 subjects each is planned to allow for a potential 10% drop-out rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kovacaine Mist, 3 sprays unilateral | Experimental | Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05%Tetracaine HCl 3% and oxymetazoline HCl 0.05% |
| Tetracaine Only, 3 sprays unilateral | Experimental | Drug: Tetracaine HCl 3%Tetracaine HCl 3% |
| Placebo, 3 sprays unilateral | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 (other than a maxillary first, second, or third molar) 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.
Key exclusion criteria (11 listed)
- Inadequately controlled hypertension (blood pressure greater than 140/90 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 last 24 hours.
- History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
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 Mist3 unilateral intranasal sprays per dose | Drug | Kovacaine Mist, 3 sprays unilateral |
| Tetracaine HCl 3%3 unilateral intranasal sprays per dose | Drug | Tetracaine Only, 3 sprays unilateral |
| Placebo3 unilateral intranasal sprays per dose | Drug | Placebo, 3 sprays unilateral |
Primary outcome
Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no).
Time frame: at 15 minutes with a 3 minute window
13 secondary outcomes
Intraoral Soft-tissue Anesthesia (Yes/no)
Time frame: at 15 minutes with a 3 minute window
Number of Participants With Heart Rate Higher Than 125 Bpm
Time frame: at any time within 120 minutes following drug administration
Number of Participants With Heart Rate Lower Than 50 Bpm
Time frame: 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 to a Value Higher Than 160 mm Hg
Time frame: 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 to a Value Lower Than 90 mm Hg
Time frame: at any time within 120 minutes following drug administration
Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 90 mm Hg
Time frame: at any time within 120 minutes following drug administration
Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg
Time frame: at any time within 120 minutes following drug administration
Absolute Maximum Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Time frame: from baseline to 120 minutes following drug administration
The Profile Over Time of Heart Rate
Time frame: from baseline to 120 minutes following drug administration
Alcohol Sniff Test
Time frame: administered at approximately 24 hours after drug administration
The Profile Over Time of Systolic Blood Pressure
Time frame: from baseline to 120 minutes following drug administration
The Profile Over Time of Diastolic Blood Pressure
Time frame: from baseline to 120 minutes following drug administration
Absolute Maximum Change From Baseline in Heart Rate
Time frame: from baseline to 120 minutes following drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul A. Moore, DMD/PhD/MPH study director
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tetracaine HCl 3% and oxymetazoline HCl 0.05% and Tetracaine HCl 3% in people with Anesthesia, run by St. Renatus, LLC at 3 sites 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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 5 Sep 2017). 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?
Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no). (time frame: at 15 minutes with a 3 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 5 Sep 2017.