AnesthesiaPhase 3NCT01745380
Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Adults
A Phase 3 study testing Tetracaine HCl 3% and Oxymetazoline HCl 0.05% 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, 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%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2013to May 2013
- 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 (anterior or premolar tooth #4 to #13) 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 (the treatment tooth).
- Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
- Seated systolic blood pressure (SBP) between 95 and 150 mm Hg, inclusive, and seated diastolic blood pressure (DBP) between 60 and 100 mm Hg, inclusive.
Who cannot join
- Inadequately controlled hypertension (blood pressure greater than 150/100 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 24 hours preceding study entry.
- 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.
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- 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 the 30 days prior to study participation.
- 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
Center for Dental Research Loma Linda University School
Loma Linda, California, 92350
University of Pennsylvania, School of Dental Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Placebo for Anesthetizing Maxillary Teeth in Adults
The purpose of this study is to compare the efficacy of Kovacaine Mist, 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. The maxillary teeth will be categorized in two subsets, anteriors (teeth numbers 6 to 11) and premolars (teeth numbers 4, 5, 12 and 13).
The intent is to treat 150 subjects at 3 study sites, 2:1 randomization within each study site, and an overall goal of 100 subjects treated with Kovacaine Mist and 50 treated with placebo. Recruitment will be from diverse dental patient populations with at least 25% of subjects over 50 years of age. Randomization will be within strata defined by age (≤50 and >50 years).
- Conditions
- Anesthesia
- Being tested
- Tetracaine HCl 3% and Oxymetazoline HCl 0.05%, 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
The study drug is regional anesthetic delivered intranasally on the same side as the operative tooth
PlaceboDrug
Also called inactive ingredients
The placebo spray was identical in appearance to and was administered in the same volume and manner as the active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Kovacaine Mist | Experimental | Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Receives: Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% |
| Placebo | Placebo comparator | Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.
Measured: at 15 minutes, +3 minute window
Secondary outcomes (14)
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years)
If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome. This outcome is broken down by age group, 1) less than 50 years of age and 2) 50 years of age and older.
Measured: at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used
Number of Participants With a Heart Rate Higher Than 125 Bpm
Measured: at any time within 120 minutes following drug administration
Number of Participants With a 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/or 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/or to a Value Lower Than 90 mm Hg
Measured: at any time within 120 minutes following study drug administration
Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Higher Than 105 mm Hg
Measured: at any time within 120 minutes following study drug administration
Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and/or to a Value Lower Than 50 mm Hg
Measured: at any time within 120 minutes following study drug administration
Maximum Change From Baseline in Heart Rate
Measured: from baseline to 120 minutes following drug administration
Maximum Change From Baseline in Systolic Blood Pressure
Measured: from baseline to 120 minutes following drug administration
Maximum Change From Baseline in 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 alcohol on a cotton ball.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionMay 2013
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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Renatus, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Triligent International, Rho, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745380
- Sponsor's protocol ID
- SR 3-03
- Status last verified
- Dec 2016
- First submitted
- 4 Dec 2012
- Last updated
- 31 Jan 2017
- 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 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Placebo for Anesthetizing Maxillary Teeth in Adults
- ClinicalTrials.gov ID
- NCT01745380
- Acronym / sponsor ID
- SR 3-03
- Conditions
- Anesthesia
- Keywords
- operative, dental procedure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- St. Renatus, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Triligent International, Rho, Inc.
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Posted 31 Jan 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, 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. The maxillary teeth will be categorized in two subsets, anteriors (teeth numbers 6 to 11) and premolars (teeth numbers 4, 5, 12 and 13).
The intent is to treat 150 subjects at 3 study sites, 2:1 randomization within each study site, and an overall goal of 100 subjects treated with Kovacaine Mist and 50 treated with placebo. Recruitment will be from diverse dental patient populations with at least 25% of subjects over 50 years of age. Randomization will be within strata defined by age (≤50 and >50 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kovacaine Mist | Experimental | Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. |
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 (anterior or premolar tooth #4 to #13) 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 (the treatment tooth).
Key exclusion criteria (10 listed)
- Inadequately controlled hypertension (blood pressure greater than 150/100 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 24 hours preceding study entry.
- 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 MistThe study drug is regional anesthetic delivered intranasally on the same side as the operative tooth | Drug | Kovacaine Mist |
| PlaceboAlso: inactive ingredientsThe placebo spray was identical in appearance to and was administered in the same volume and manner as the active ingredient. | Drug | Placebo |
Primary outcome
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
Time frame: at 15 minutes, +3 minute window
If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.
14 secondary outcomes
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years)
Time frame: at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used
Number of Participants With a Heart Rate Higher Than 125 Bpm
Time frame: at any time within 120 minutes following drug administration
Number of Participants With a 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/or 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/or to a Value Lower Than 90 mm Hg
Time frame: at any time within 120 minutes following study drug administration
Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Higher Than 105 mm Hg
Time frame: at any time within 120 minutes following study drug administration
Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and/or to a Value Lower Than 50 mm Hg
Time frame: at any time within 120 minutes following study drug administration
Maximum Change From Baseline in Heart Rate
Time frame: from baseline to 120 minutes following drug administration
Maximum Change From Baseline in Systolic Blood Pressure
Time frame: from baseline to 120 minutes following drug administration
Maximum Change From Baseline in 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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% 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 10 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 31 Jan 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 31 Jan 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?
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. (time frame: at 15 minutes, +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 31 Jan 2017.