AnesthesiaPhase 3NCT01844830
Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Pediatric Patients
A Phase 3 study testing Tetracaine HCl 3% and Oxymetazoline HCl 0.05% in people with Anesthesia, run by St. Renatus, LLC at 2 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 pediatric patients. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- 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
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2013to Jul 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female 3-17 years of age inclusive.
- Need for an operative restorative dental procedure and requiring local anesthesia on a single vital maxillary primary tooth (#A to J) or permanent tooth (#4 to13), with no evidence of pulpal pathology.
- Normal lip, nose, eyelid, and cheek sensation.
- Accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document.
- Subject able to understand and provide assent to an age-appropriate subject assent form (as defined by local practice or regulation).
- Patient or parent/guardian able to communicate with the investigator and comply with the requirements of the protocol.
- Patency of the naris on the same side as the tooth undergoing the Study Dental Procedure (the Study Treatment Tooth).
Who cannot join
- 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 lidocaine, oxymetazoline, epinephrine, or sulfite preservatives.
- 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 undergo urine testing on the day of, but prior to, study drug administration to rule out pregnancy.)
- Inadequately controlled thyroid disease of any type.
Show all 10Show fewer
- Having received any investigational drug (including Kovacaine Mist) and/or participation in any clinical trial within 30 days of study participation.
- Frequent nose bleeds (≥ 5 per month).
- History of congenital or idiopathic methemoglobinemia.
- Presence of an upper respiratory infection and/or fever defined as body temperature ≥100.4° (38°C) on the day of and prior to study drug administration.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Big Grins
Fort Collins, Colorado, 80525
Center for Dental Research Loma Linda University School
Loma Linda, California, 92350
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 Pediatric Patients
The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for inducing pulpal anesthesia of the maxillary teeth in pediatric patients.
Read the detailed description
The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to demonstrate the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary permanent teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) or maxillary primary teeth numbers A to J (maxillary right second primary molar to maxillary left second primary molar) sufficient to allow completion of the Study Dental Procedure. The maxillary teeth will be categorized in two subsets, anterior teeth (permanent teeth numbers 6 to 11 and primary teeth numbers C to H) and posterior teeth (permanent teeth numbers 4, 5, 12, 13 and primary teeth numbers A, B, I, J).
The intent is to treat 90 male and female subjects aged 3 to 17 years, inclusive, at 3 study sites, 2:1 randomization within each study site, and an overall goal of 60 subjects treated with Kovacaine Mist and 30 treated with placebo. Subjects will receive Kovacaine Mist or placebo (2:1) according to the kit randomization plan within three dosing strata (100 µL, 200 µL or 400 µL) based on subject weight at entry: subjects weighing 10 to <20 kg, 20 to <40 kg and ≥ 40 kg will be assigned to the 100 µL, 200 µL or 400 µL dose group, respectively. Recruitment will be from diverse pediatric dental patient populations. To ensure adequate representation in the 3 dose/weight groups, each stratum will contain at least 25% of subjects.
- 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
Intranasally administered regional anesthetic
PlaceboDrug
Also called Intranasal administration of inactive ingredients
Inactive ingredients supplied in identical nasal sprayer
| Study group | Role | What they receive |
|---|---|---|
| Kovacaine Mist | Experimental | Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total); Receives: Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% |
| Placebo | Placebo comparator | Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total); 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: 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window
Secondary outcomes (11)
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.by Dosage Cohort.
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: 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. by Age Group (3-5, 6-11, and 12-17 Years Old, Inclusive).
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: 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window
Incidence of Adverse Events (AEs) by Dosage Cohort
Patients with AEs
Measured: from baseline to 24 hours following drug administration
Incidence of Adverse Events (AEs) by Age Group
Patients with AEs
Measured: from baseline to 24 hours following drug administration
Results of Naris Examination (NE) - Patency and Ulcerations
The investigators evaluated the treatment naris for patency and ulcerations.
Patency was evaluated as followed: The nostril not used for dosing study drug was manually occluded and the subject was asked to sniff gently. Airflow in the naris was used to determine if it was patent (yes) or not (no).
For ulcers, the investigators performed a visual examination for the presence of ulcers and recorded if they were present (yes) or not (no).
Measured: 120 minutes post drug administration
Maximum Change From Baseline in Heart Rate
Measured: from baseline to 24 hours following drug administration
Maximum Change From Baseline in Systolic Blood Pressure
Measured: from baseline to 24 hours following drug administration
Maximum Change From Baseline in Diastolic Blood Pressure
Measured: from baseline to 24 hours following drug administration
Results of Naris Examination (NE) - Color
The investigators performed a visual inspection and evaluated the treatment naris for color of the mucosa. The investigator determined what color (Pink, Slightly Red, Red) best matched and recorded the results.
Measured: 120 minutes post drug administration
Results of Naris Examination (NE) - Inflammation
Measured: 120 minutes post drug administration
Results of Naris Examination (NE) - Bleeding
Measured: 120 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 posted1 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 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
- 90 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
- NCT01844830
- Sponsor's protocol ID
- SR 3-04
- Status last verified
- Jul 2017
- First submitted
- 29 Apr 2013
- Last updated
- 30 Aug 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 30 Aug 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 Pediatric Patients
- ClinicalTrials.gov ID
- NCT01844830
- Acronym / sponsor ID
- SR 3-04
- Conditions
- Anesthesia
- Keywords
- operative, dental procedure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- St. Renatus, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Triligent International, Rho, Inc.
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Posted 30 Aug 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 pediatric patients.
Detailed description
The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to demonstrate the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary permanent teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) or maxillary primary teeth numbers A to J (maxillary right second primary molar to maxillary left second primary molar) sufficient to allow completion of the Study Dental Procedure. The maxillary teeth will be categorized in two subsets, anterior teeth (permanent teeth numbers 6 to 11 and primary teeth numbers C to H) and posterior teeth (permanent teeth numbers 4, 5, 12, 13 and primary teeth numbers A, B, I, J).
The intent is to treat 90 male and female subjects aged 3 to 17 years, inclusive, at 3 study sites, 2:1 randomization within each study site, and an overall goal of 60 subjects treated with Kovacaine Mist and 30 treated with placebo. Subjects will receive Kovacaine Mist or placebo (2:1) according to the kit randomization plan within three dosing strata (100 µL, 200 µL or 400 µL) based on subject weight at entry: subjects weighing 10 to <20 kg, 20 to <40 kg and ≥ 40 kg will be assigned to the 100 µL, 200 µL or 400 µL dose group, respectively. Recruitment will be from diverse pediatric dental patient populations. To ensure adequate representation in the 3 dose/weight groups, each stratum will contain at least 25% of subjects.
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% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total); |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total); |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male or female 3-17 years of age inclusive.
- Need for an operative restorative dental procedure and requiring local anesthesia on a single vital maxillary primary tooth (#A to J) or permanent tooth (#4 to13), with no evidence of pulpal pathology.
- Normal lip, nose, eyelid, and cheek sensation.
- Accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document.
- Subject able to understand and provide assent to an age-appropriate subject assent form (as defined by local practice or regulation).
Key exclusion criteria (10 listed)
- 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 lidocaine, oxymetazoline, epinephrine, or sulfite preservatives.
- 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 undergo urine testing on the day of, but prior to, study drug administration to rule out pregnancy.)
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 MistIntranasally administered regional anesthetic | Drug | Kovacaine Mist |
| PlaceboAlso: Intranasal administration of inactive ingredientsInactive ingredients supplied in identical nasal sprayer | Drug | Placebo |
Primary outcome
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
Time frame: 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - 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.
11 secondary outcomes
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.by Dosage Cohort.
Time frame: 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. by Age Group (3-5, 6-11, and 12-17 Years Old, Inclusive).
Time frame: 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window
Incidence of Adverse Events (AEs) by Dosage Cohort
Time frame: from baseline to 24 hours following drug administration
Incidence of Adverse Events (AEs) by Age Group
Time frame: from baseline to 24 hours following drug administration
Results of Naris Examination (NE) - Patency and Ulcerations
Time frame: 120 minutes post drug administration
Maximum Change From Baseline in Heart Rate
Time frame: from baseline to 24 hours following drug administration
Maximum Change From Baseline in Systolic Blood Pressure
Time frame: from baseline to 24 hours following drug administration
Maximum Change From Baseline in Diastolic Blood Pressure
Time frame: from baseline to 24 hours following drug administration
Results of Naris Examination (NE) - Color
Time frame: 120 minutes post drug administration
Results of Naris Examination (NE) - Inflammation
Time frame: 120 minutes post drug administration
Results of Naris Examination (NE) - Bleeding
Time frame: 120 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 30 Aug 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.
2 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 2 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 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 30 Aug 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: 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - 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 30 Aug 2017.