AnesthesiaPhase 2NCT01807624
Safety and Pharmacokinetics of Kovacaine Nasal Spray (24 Hour Blood Collection)
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/pharmacodynamics and safety of a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline with blood draws over 24 hours. Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2013
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-breast-feeding female subjects between the ages of 18 and 75 years (inclusive).
- Can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol.
- Body mass index between 18 and 35 BMI.
- Sufficiently healthy as determined by the investigator to receive the test medications and undergo the scheduled study procedure.
- Can breathe through both nostrils.
- Screening BP ≤ 140/90 mm Hg.
Who cannot join
- History of clinically significant respiratory, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, including cardiac arrhythmia, narrow angle glaucoma and benign prostatic hypertrophy (in men), uncontrolled thyroid disease (including Hashimoto's Thyroiditis and lymphocytic thyroiditis), uncontrolled diabetes mellitus or any other condition which, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Has clinically significant abnormal findings on the physical examination, medical history, electrocardiogram (ECG), or clinical laboratory evaluation during screening. This includes current upper respiratory infections.
- 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 polyps, significant nasal or sinus surgery or other abnormality that may interfere with the dose administration.
- History of allergic or adverse responses to tetracaine, other ester local anesthetics, PBBA, oxymetazoline and its preservatives, or para-aminobenzoic acid as found in PABA containing sunscreens or any comparable or similar product.
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- Donation of blood or plasma within 30 days of the first dose of Study Drug.
- Participation in a clinical trial within 30 days prior to the first dose of Study Drug.
- Use of any new over-the-counter (OTC) medication, including topical anesthetic creams or gels, vitamins, within seven days prior to the first dose of the Study Drug or during the study unless approved by the Principal Investigator.
- Any prescription medication, whose dose is not stable at the time of screening, as determined by the Principal Investigator.
- Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of Study Drug or during the study.
- Smoking or use of tobacco products within 6 months prior to the first dose of Study Drug or during the study.
- Female trying to conceive, is pregnant, suspected of being pregnant, or is lactating. (Females of child-bearing potential will be required to take a serum pregnancy test at screening (up to 21 days prior to the start of the study, including the day of the study), as well as a urine pregnancy test at check-in to rule out pregnancy.)
- Positive serum pregnancy test at screening or urine pregnancy test at check-in for all women of childbearing potential.
- Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C, or a positive urine screen for alcohol, drugs of abuse, or cotinine.
- Have a history of pseudocholinesterase deficiency or previous prolonged paralysis with succinylcholine or difficulty waking up from general anesthesia.
- Have a history of alcoholism and/or drug abuse.
- Have taken a monoamine oxidase inhibitor or vasopressor drug within the past 3 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pharmacokinetics Of Tetracaine, Para-Butylaminobenzoic Acid, And Oxymetazoline After Intranasal Administration Of The Highest Phase 3 Dose Of Kovacaine™ Mist To Healthy Volunteers
The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline with blood draws over 24 hours.
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 highest Phase 3 dose of Kovacaine Mist (Tetracaine Hydrochloride with Oxymetazoline Hydrochloride) to healthy volunteers.
This is an open-label, single-treatment, single-dose study in healthy volunteers in which all subjects will receive the highest Phase 3 dose of Kovacaine Mist on one occasion. No randomization is necessary for this single treatment, single dose study. A single study center will participate.
Each subject will receive a single dose of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) consisting of 3 sprays (each 0.2 mL) in one nostril not taking longer than 8 minutes, for a total 0.6 mL dose containing 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl.
The total dosing period will be 8 minutes. Subjects will be required to fast 10 hours prior to dosing and for four (4) hours after dosing. Water will be allowed ad lib during the study except for one (1) hour prior through one (1) hour after dose administration. Subjects will be admitted to the study unit no later than 2100 hours of the evening prior to drug administration and will remain in the unit until the 24 hour blood sample is collected and discharge procedures are completed.
- 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 Nasal Spray
1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl (para-butylaminobenzoic acid or PABA is active metabolite)
| Study group | Role | What they receive |
|---|---|---|
| Kovacaine Mist | Experimental | Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure 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.
Cmax of Oxymetazoline and PBBA
Measured: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Tmax of Oxymetazoline and PBBA
Measured: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Half-life of Oxymetazoline and PBBA
Measured: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
AUC0-t of Oxymetazoline and PBBA
Measured: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
AUC0-infinity of Oxymetazoline and PBBA
Measured: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Secondary outcomes (8)
Increase in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication
Measured: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Decrease in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication
Measured: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Increase in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication
Measured: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Decrease in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication
Measured: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Increase in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication
Measured: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Decrease in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication
Measured: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
SpO2 Increase of > 5% on 2 Consecutive Measurements After Administration of Study Medication
Measured: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
SpO2 Decrease of > 5% on 2 Consecutive Measurements After Administration of Study Medication
Measured: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 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 posted8 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2013
- Study completionMar 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Renatus, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Triligent International, Rho, Inc., Analytical Bio-Chemistry Laboratories, Inc.
- Responsible party
- Sponsor
- Investigators
- Jim Mulvahill, Study chair, St. Renatus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807624
- Sponsor's protocol ID
- SR 2-06
- Status last verified
- Jul 2017
- First submitted
- 5 Mar 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
- The Pharmacokinetics Of Tetracaine, Para-Butylaminobenzoic Acid, And Oxymetazoline After Intranasal Administration Of The Highest Phase 3 Dose Of Kovacaine™ Mist To Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01807624
- Acronym / sponsor ID
- SR 2-06
- Conditions
- Anesthesia
- Keywords
- Pharmacokinetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- St. Renatus, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Triligent International, Rho, Inc., Analytical Bio-Chemistry Laboratories, Inc.
- Study start
- Mar 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Posted 29 Dec 2016
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/pharmacodynamics and safety of a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline with blood draws over 24 hours.
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 highest Phase 3 dose of Kovacaine Mist (Tetracaine Hydrochloride with Oxymetazoline Hydrochloride) to healthy volunteers.
This is an open-label, single-treatment, single-dose study in healthy volunteers in which all subjects will receive the highest Phase 3 dose of Kovacaine Mist on one occasion. No randomization is necessary for this single treatment, single dose study. A single study center will participate.
Each subject will receive a single dose of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) consisting of 3 sprays (each 0.2 mL) in one nostril not taking longer than 8 minutes, for a total 0.6 mL dose containing 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl.
The total dosing period will be 8 minutes. Subjects will be required to fast 10 hours prior to dosing and for four (4) hours after dosing. Water will be allowed ad lib during the study except for one (1) hour prior through one (1) hour after dose administration. Subjects will be admitted to the study unit no later than 2100 hours of the evening prior to drug administration and will remain in the unit until the 24 hour blood sample is collected and discharge procedures are completed.
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% - 3 sprays will be administered at the start of the procedure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or non-pregnant, non-breast-feeding female subjects between the ages of 18 and 75 years (inclusive).
- Can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol.
- Body mass index between 18 and 35 BMI.
- Sufficiently healthy as determined by the investigator to receive the test medications and undergo the scheduled study procedure.
- Can breathe through both nostrils.
Key exclusion criteria (18 listed)
- History of clinically significant respiratory, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, including cardiac arrhythmia, narrow angle glaucoma and benign prostatic hypertrophy (in men), uncontrolled thyroid disease (including Hashimoto's Thyroiditis and lymphocytic thyroiditis), uncontrolled diabetes mellitus or any other condition which, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Has clinically significant abnormal findings on the physical examination, medical history, electrocardiogram (ECG), or clinical laboratory evaluation during screening. This includes current upper respiratory infections.
- 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 polyps, significant nasal or sinus surgery or other abnormality that may interfere with the dose administration.
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 Nasal Spray1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl (para-butylaminobenzoic acid or PABA is active metabolite) | Drug | Kovacaine Mist |
Primary outcome
Cmax of Oxymetazoline and PBBA
Time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Tmax of Oxymetazoline and PBBA
Time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Half-life of Oxymetazoline and PBBA
Time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
AUC0-t of Oxymetazoline and PBBA
Time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
AUC0-infinity of Oxymetazoline and PBBA
Time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
8 secondary outcomes
Increase in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication
Time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Decrease in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication
Time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Increase in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication
Time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Decrease in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication
Time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Increase in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication
Time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
Decrease in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication
Time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
SpO2 Increase of > 5% on 2 Consecutive Measurements After Administration of Study Medication
Time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
SpO2 Decrease of > 5% on 2 Consecutive Measurements After Administration of Study Medication
Time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray
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.
Jim Mulvahill study chair
St. Renatus
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 6 inclusion and 18 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 29 Dec 2016). 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?
Cmax of Oxymetazoline and PBBA (time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray). The study lists 5 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 30 Aug 2017.