AnesthesiaPhase 2NCT01952990
Safety and Pharmacokinetics of Kovacaine Nasal Spray in Pediatric Subjects
A Phase 2 study testing Tetracaine HCl 3% and Oxymetazoline HCl 0.05% in people with Anesthesia, run by St. Renatus, LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine the pharmacokinetics and safety of a nasal spray containing the anesthetic drug Tetracaine in combination with Oxymetazoline in healthy 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?
- Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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.
- Sufficiently healthy as determined by the investigator to receive the test medications.
- 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.
- Within the 10th and 90th percentiles for weight by age.
- Can breathe through both nostrils.
- Body mass index from 14 and 30 kg/m2 inclusive.
Who cannot join
- Any chronic or currently uncontrolled psychiatric, 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.
- Inadequately controlled thyroid disease of any type.
- Has clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory evaluation during screening.
- Currently experiencing seasonal or perennial allergic rhinitis, recurrent nose-bleeds or asthma, or has a significant history of these conditions, in the opinion of the Investigator.
- Current, including the last 30 days, sinusitis or other upper respiratory infections, nasal congestion or use of a "sinus medication" within the 48 hours prior to anticipated study participation.
- Nasal polyps, significant nasal or sinus surgery or other abnormality that may interfere with the dose administration.
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- History of allergy to or intolerance of tetracaine, oxymetazoline, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
- 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 at the baseline visit to rule out pregnancy.)
- Having received any investigational drug (including Kovacaine Mist) and/or participation in any clinical trial within 30 days of study participation.
- History of congenital or idiopathic methemoglobinemia.
- 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.
- Have a history of pseudocholinesterase deficiency or previous prolonged paralysis with succinylcholine or difficulty waking up from general anesthesia.
- Fever defined as body temperature ≥100.4 (38°C) on the day of and prior to study drug administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
AXIS Clinical Trials Research Center
Los Angeles, California, 90036
About this study
Official title: A Single-Center, Study Evaluating The Pharmacokinetics Of Tetracaine, Para-Butylaminobenzoic Acid, And Oxymetazoline After Intranasal Administration Of Kovacaine Mist To Healthy Pediatric Subjects
The purpose of this study is to determine the pharmacokinetics and safety of a nasal spray containing the anesthetic drug Tetracaine in combination with Oxymetazoline in healthy pediatric subjects.
Read the detailed description
The purpose of this study is to determine the pharmacokinetics and safety of tetracaine, para- butylaminobenzoic acid (PBBA), and oxymetazoline after intranasal administration of the recommended, weight-based Phase 3 dose of Kovacaine Mist (Tetracaine Hydrochloride with Oxymetazoline Hydrochloride) to healthy pediatric subjects.
Kovacaine Mist is an anesthetic solution containing 3% tetracaine hydrochloride and 0.05% oxymetazoline hydrochloride. A single spray dose of 100 μL Kovacaine Mist contains 3 mg tetracaine HCl and 0.05 mg oxymetazoline HCl. A two-100 μL spray dose (a total of 200 μL) of Kovacaine Mist contains 6 mg tetracaine HCl and 0.1 mg oxymetazoline HCl. A two-200 μL spray dose (a total of 400 μL) of Kovacaine Mist contains 12 mg tetracaine HCl and 0.2 mg oxymetazoline HCl.
Kovacaine Mist will be administered based on the weight of the subject as summarized in the table below. Subjects weighing 10 to <20 kg will receive 1 intranasal spray of 100 μL of Kovacaine Mist at time D0. Subjects weighing 20 to <40 kg will receive 2 intranasal sprays of 100 μL (total dose 200 μL) administered 4 minutes apart at times D0 and D4. Subjects weighing 40 kg or more will receive 2 intranasal sprays of 200 μL (total dose 400 μL) administered 4 minutes apart at times D0 and D4.
- Conditions
- Anesthesia
- Being tested
- Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
- Keywords
- Pharmacokinetic
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
1 spray device is 0.2mL (200 μL) in volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl. Subjects receiving the 100 μL dose will receive half of the contents of one device using a dose divider. Subjects receiving the 200 μL dose will first receive half of the contents of one device using a dose divider and then 4 minutes later will receive the 2nd half by removing the dose divider. Subjects receiving the 400 μL dose will first receive the entire contents of one device and then 4 minutes later will receive the contents of a 2nd device.
| Study group | Role | What they receive |
|---|---|---|
| Kovacaine Mist | Experimental | Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Total dose is based on weight. Subjects weighing 10 to <20 kg will receive 1 intranasal spray of 100 μL. Subjects weighing 20 to <40 kg will receive 2 intranasal sprays of 100 μL (total dose 200 μL.
Subjects weighing 40 kg or more will receive 2 intranasal sprays of 200 μL (total dose 400 μL). Receives: Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of tetracaine
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Time to Peak Plasma Concentration (Cmax) of tetracaine
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Terminal elimination rate constant (λz) of tetracaine
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Elimination half-life (t½) of tetracaine
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Area under the plasma concentration versus time curve (AUC) of tetracaine
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Peak Plasma Concentration (Cmax) of para- butylaminobenzoic acid (PBBA)
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Time to Peak Plasma Concentration (Cmax) of para- butylaminobenzoic acid (PBBA)
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Terminal elimination rate constant (λz) of para- butylaminobenzoic acid (PBBA)
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Elimination half-life (t½) of para- butylaminobenzoic acid (PBBA)
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Area under the plasma concentration versus time curve (AUC) of para- butylaminobenzoic acid (PBBA)
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Peak Plasma Concentration (Cmax) of oxymetazoline
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Time to Peak Plasma Concentration (Cmax) of oxymetazoline
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Terminal elimination rate constant (λz) of oxymetazoline
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Elimination half-life (t½) of oxymetazoline
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Area under the plasma concentration versus time curve (AUC) of oxymetazoline
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Secondary outcomes (5)
Mean and Standard Deviation of Heart Rate
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Mean and Standard Deviation of Systolic Blood Pressure
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Mean and Standard Deviation of Diastolic Blood Pressure
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Mean and Standard Deviation of Temperature
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Mean and Standard Deviation of Oxygen Saturation
Measured: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Renatus, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Triligent International, Analytical Bio-Chemistry Laboratories, Inc., Rho, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952990
- Sponsor's protocol ID
- SR 2-07
- Status last verified
- May 2015
- First submitted
- 25 Sep 2013
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Study Evaluating The Pharmacokinetics Of Tetracaine, Para-Butylaminobenzoic Acid, And Oxymetazoline After Intranasal Administration Of Kovacaine Mist To Healthy Pediatric Subjects
- ClinicalTrials.gov ID
- NCT01952990
- Acronym / sponsor ID
- SR 2-07
- Conditions
- Anesthesia
- Keywords
- Pharmacokinetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- St. Renatus, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Triligent International, Analytical Bio-Chemistry Laboratories, Inc., Rho, Inc.
- Study start
- Sep 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
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 determine the pharmacokinetics and safety of a nasal spray containing the anesthetic drug Tetracaine in combination with Oxymetazoline in healthy pediatric subjects.
Detailed description
The purpose of this study is to determine the pharmacokinetics and safety of tetracaine, para- butylaminobenzoic acid (PBBA), and oxymetazoline after intranasal administration of the recommended, weight-based Phase 3 dose of Kovacaine Mist (Tetracaine Hydrochloride with Oxymetazoline Hydrochloride) to healthy pediatric subjects.
Kovacaine Mist is an anesthetic solution containing 3% tetracaine hydrochloride and 0.05% oxymetazoline hydrochloride. A single spray dose of 100 μL Kovacaine Mist contains 3 mg tetracaine HCl and 0.05 mg oxymetazoline HCl. A two-100 μL spray dose (a total of 200 μL) of Kovacaine Mist contains 6 mg tetracaine HCl and 0.1 mg oxymetazoline HCl. A two-200 μL spray dose (a total of 400 μL) of Kovacaine Mist contains 12 mg tetracaine HCl and 0.2 mg oxymetazoline HCl.
Kovacaine Mist will be administered based on the weight of the subject as summarized in the table below. Subjects weighing 10 to <20 kg will receive 1 intranasal spray of 100 μL of Kovacaine Mist at time D0. Subjects weighing 20 to <40 kg will receive 2 intranasal sprays of 100 μL (total dose 200 μL) administered 4 minutes apart at times D0 and D4. Subjects weighing 40 kg or more will receive 2 intranasal sprays of 200 μL (total dose 400 μL) administered 4 minutes apart at times D0 and D4.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kovacaine Mist | Experimental | Drug: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Total dose is based on weight. Subjects weighing 10 to <20 kg will receive 1 intranasal spray of 100 μL. Subjects weighing 20 to <40 kg will receive 2 intranasal sprays of 100 μL (total dose 200 μL. Subjects weighing 40 kg or more will receive 2 intranasal sprays of 200 μL (total dose 400 μL). |
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.
- Sufficiently healthy as determined by the investigator to receive the test medications.
- 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.
Key exclusion criteria (14 listed)
- Any chronic or currently uncontrolled psychiatric, 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.
- Inadequately controlled thyroid disease of any type.
- Has clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory evaluation during screening.
- Currently experiencing seasonal or perennial allergic rhinitis, recurrent nose-bleeds or asthma, or has a significant history of these conditions, in the opinion of the Investigator.
- Current, including the last 30 days, sinusitis or other upper respiratory infections, nasal congestion or use of a "sinus medication" within the 48 hours prior to anticipated study participation.
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 Mist1 spray device is 0.2mL (200 μL) in volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl. Subjects receiving the 100 μL dose will receive half of the contents of one device using a dose divider. Subjects receiving the 200 μL dose will first receive half of the contents of one device using a dose divider and then 4 minutes later will receive the 2nd half by removing the dose divider. Subjects receiving the 400 μL dose will first receive the entire contents of one device and then 4 minutes later will receive the contents of a 2nd device. | Drug | Kovacaine Mist |
Primary outcome
Peak Plasma Concentration (Cmax) of tetracaine
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Time to Peak Plasma Concentration (Cmax) of tetracaine
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Terminal elimination rate constant (λz) of tetracaine
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Elimination half-life (t½) of tetracaine
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Area under the plasma concentration versus time curve (AUC) of tetracaine
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Peak Plasma Concentration (Cmax) of para- butylaminobenzoic acid (PBBA)
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Time to Peak Plasma Concentration (Cmax) of para- butylaminobenzoic acid (PBBA)
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Terminal elimination rate constant (λz) of para- butylaminobenzoic acid (PBBA)
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Elimination half-life (t½) of para- butylaminobenzoic acid (PBBA)
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Area under the plasma concentration versus time curve (AUC) of para- butylaminobenzoic acid (PBBA)
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Peak Plasma Concentration (Cmax) of oxymetazoline
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Time to Peak Plasma Concentration (Cmax) of oxymetazoline
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Terminal elimination rate constant (λz) of oxymetazoline
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Elimination half-life (t½) of oxymetazoline
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Area under the plasma concentration versus time curve (AUC) of oxymetazoline
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
5 secondary outcomes
Mean and Standard Deviation of Heart Rate
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Mean and Standard Deviation of Systolic Blood Pressure
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Mean and Standard Deviation of Diastolic Blood Pressure
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Mean and Standard Deviation of Temperature
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Mean and Standard Deviation of Oxygen Saturation
Time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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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.
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 Tetracaine HCl 3% and Oxymetazoline HCl 0.05% 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 14 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 8 Jun 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak Plasma Concentration (Cmax) of tetracaine (time frame: 0, 10, 30 minutes, and 1, 3, 6, 8, 9, 12, and 24 hours after completion of the last nasal spray). The study lists 15 primary outcomes in all. 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 8 Jun 2015.