AnesthesiaPhase 2NCT01701505
Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects
A Phase 2 study testing 400uL of Kovacaine Mist, 200uL of Kovacaine Mist and 120uL of Kovacaine Mist in people with Anesthesia, run by St. Renatus, LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- 400uL of Kovacaine Mist, 200uL of Kovacaine Mist and 120uL of Kovacaine Mist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female 3-17 years of age inclusive.
- Need for an operative restorative dental procedure on a single vital maxillary primary tooth (#A to J) or permanent tooth (#4 to13), other than a maxillary permanent first, second or third molar, requiring local anesthesia with an expected treatment duration not exceeding 60 minutes.
- 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.
- If age 8 and above, able to understand and provide informed assent.
- Patient or parent/guardian able to communicate with the investigator and comply with the requirements of the protocol.
- Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.
- Minimum weight: Subjects in Cohorts A and B (age 6 and above) must weigh at least 20kg (44 lb.). Subjects in Cohort C (age 3 and above) must weigh at least 10kg (22 lb.).
Who cannot join
- Dental care requiring a local anesthetic within the 24 hours prior to anticipated study participation.
- 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 take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
- Inadequately controlled thyroid disease of any type.
Show all 16Show fewer
- Use of 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).
- Anticipated need for use of 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.
- Clinically relevant history of sinus/nasal surgery, recent epistaxis, nasal congestion or sinus infections, or use of a "sinus medication" within the 48 hours prior to anticipated study participation.
- History of alcoholism and/or drug abuse.
- Pulpal pathology in the index tooth.
- Anticipated need for use of nitrous oxide before or during the Study Dental Procedure.
- Any chronic or currently uncontrolled psychogenic, neurological, endocrine, pulmonary, cardiovascular, renal, gastrointestinal or hepatic disease or condition with manifestations that might confound interpretation of study results or make receipt of study medication a source of risk for adverse outcome.
- Fever defined as body temperature ≥100° (37°C) on the day of and prior to study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Single-Center, Open-Label, Randomized, Parallel-Groups, Dose-Ranging Study to Assess the Efficacy and Safety of Intranasally Administered Kovacaine Mist for Anesthetizing Maxillary Teeth in Pediatric Subjects
The purpose of this study is to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.
Read the detailed description
This is a single-center, open-label, randomized, parallel-groups, dose-ranging study to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.
The study will employ an open-label design to determine the lowest effective doses (LEDs), and assess the safety and efficacy of Kovacaine Mist administered intranasally for inducing pulpal anesthesia of maxillary primary teeth numbers A to J and maxillary permanent teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure, and will be carried out in healthy children of either sex between the ages of 3 and 17 years, inclusive.
- Conditions
- Anesthesia
- Being tested
- 400uL of Kovacaine Mist, 200uL of Kovacaine Mist, 120uL of Kovacaine Mist
- Keywords
- operative, dental procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400uL of Kovacaine MistDrug
Also called Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
2 unilateral intranasal sprays of 200uL each.
200uL of Kovacaine MistDrug
Also called Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
2 unilateral intranasal sprays of 100uL each.
120uL of Kovacaine MistDrug
Also called Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
2 unilateral intranasal sprays of 60uL each.
| Study group | Role | What they receive |
|---|---|---|
| Kovacaine Mist High Dose | Experimental | 400uL of Kovacaine Mist, as 2 sprays of 200uL. Receives: Drug: 400uL of Kovacaine Mist |
| Kovacaine Mist Mid Dose | Experimental | 200uL of Kovacaine Mist, as 2 sprays of 100uL. Receives: Drug: 200uL of Kovacaine Mist |
| Kovacaine Mist Low Dose | Experimental | 120uL of Kovacaine Mist, as 2 sprays of 60uL. Receives: Drug: 120uL of Kovacaine Mist |
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 14 minutes with a 3 minute window
Secondary outcomes (7)
Naris Examination (NE) to Assess Reactions to the Study Drug.
The principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding.
Measured: At Baseline and 120 Minutes
Systolic Blood Pressure
Measured: At Baseline, 12 minutes, and 120 minutes
Diastolic Blood Pressure
Measured: At Baseline, 12 minutes, and 120 minutes
Heart Rate
Measured: At Baseline, 12 minutes, and 120 minutes
Oxygen Saturation
Measured: At Baseline, 12 minutes, and 120 minutes
Number of Participants With Adverse Events by Dose Level and Age
Measured: from baseline to 24 hours following drug administration
Incidence of Adverse Events by Dose Level Regardless of Age
Measured: from baseline to 24 hours 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 posted5 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2012
- Study completionOct 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT01701505
- Sponsor's protocol ID
- SR 2-03
- Status last verified
- Jul 2017
- First submitted
- 2 Oct 2012
- 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 2, Single-Center, Open-Label, Randomized, Parallel-Groups, Dose-Ranging Study to Assess the Efficacy and Safety of Intranasally Administered Kovacaine Mist for Anesthetizing Maxillary Teeth in Pediatric Subjects
- ClinicalTrials.gov ID
- NCT01701505
- Acronym / sponsor ID
- SR 2-03
- Conditions
- Anesthesia
- Keywords
- operative, dental procedure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- St. Renatus, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Triligent International, Rho, Inc.
- Study start
- Oct 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Oct 2012 (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 assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.
Detailed description
This is a single-center, open-label, randomized, parallel-groups, dose-ranging study to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.
The study will employ an open-label design to determine the lowest effective doses (LEDs), and assess the safety and efficacy of Kovacaine Mist administered intranasally for inducing pulpal anesthesia of maxillary primary teeth numbers A to J and maxillary permanent teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure, and will be carried out in healthy children of either sex between the ages of 3 and 17 years, inclusive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kovacaine Mist High Dose | Experimental | Drug: 400uL of Kovacaine Mist400uL of Kovacaine Mist, as 2 sprays of 200uL. |
| Kovacaine Mist Mid Dose | Experimental | Drug: 200uL of Kovacaine Mist200uL of Kovacaine Mist, as 2 sprays of 100uL. |
| Kovacaine Mist Low Dose | Experimental | Drug: 120uL of Kovacaine Mist120uL of Kovacaine Mist, as 2 sprays of 60uL. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male or female 3-17 years of age inclusive.
- Need for an operative restorative dental procedure on a single vital maxillary primary tooth (#A to J) or permanent tooth (#4 to13), other than a maxillary permanent first, second or third molar, requiring local anesthesia with an expected treatment duration not exceeding 60 minutes.
- 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.
- If age 8 and above, able to understand and provide informed assent.
Key exclusion criteria (16 listed)
- Dental care requiring a local anesthetic within the 24 hours prior to anticipated study participation.
- 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 take a urine pregnancy test 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 |
|---|---|---|
| 400uL of Kovacaine MistAlso: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%2 unilateral intranasal sprays of 200uL each. | Drug | Kovacaine Mist High Dose |
| 200uL of Kovacaine MistAlso: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%2 unilateral intranasal sprays of 100uL each. | Drug | Kovacaine Mist Mid Dose |
| 120uL of Kovacaine MistAlso: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%2 unilateral intranasal sprays of 60uL each. | Drug | Kovacaine Mist Low Dose |
Primary outcome
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
Time frame: at 14 minutes with a 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.
7 secondary outcomes
Naris Examination (NE) to Assess Reactions to the Study Drug.
Time frame: At Baseline and 120 Minutes
Systolic Blood Pressure
Time frame: At Baseline, 12 minutes, and 120 minutes
Diastolic Blood Pressure
Time frame: At Baseline, 12 minutes, and 120 minutes
Heart Rate
Time frame: At Baseline, 12 minutes, and 120 minutes
Oxygen Saturation
Time frame: At Baseline, 12 minutes, and 120 minutes
Number of Participants With Adverse Events by Dose Level and Age
Time frame: from baseline to 24 hours following drug administration
Incidence of Adverse Events by Dose Level Regardless of Age
Time frame: from baseline to 24 hours following 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.
Paul A. Moore, DMD/PhD/MPH study director
University of Pittsburgh
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 400uL of Kovacaine Mist, 200uL of Kovacaine Mist and 120uL of Kovacaine Mist 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 8 inclusion and 16 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 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 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: at 14 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 30 Aug 2017.