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| Name | Class |
|---|---|
| Triligent International | INDUSTRY |
| Rho, Inc. | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetracaine HCl 3% and Oxymetazoline HCl 0.05% | Drug | The study drug is regional anesthetic delivered intranasally on the same side as the operative tooth |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 15 minutes, +3 minute window |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received Three Sprays and Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. | A participant will receive two sprays and Study Dental Procedure will begin. If the participant does not have sufficient anesthesia a third sprays will be given. If after the third spray, the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic. This outcome analyzes just the participants who received the third spray and whether or not they completed the Study Dental Procedure without need for rescue by injection of local anesthesia. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dental Research Loma Linda University School | Loma Linda | California | 92350 | United States | ||
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Subjects were screened and enrolled at 3 sites in the U.S.
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| ID | Title | Description |
|---|---|---|
| FG000 | Kovacaine Mist | 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. Tetracaine HCl 3% and Oxymetazoline HCl 0.05% |
| FG001 | Placebo | Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Kovacaine Mist | 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. Tetracaine HCl 3% and Oxymetazoline HCl 0.05% |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | at 15 minutes, +3 minute window |
|
Approximately 24 hours following drug administration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Kovacaine Mist | 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. Tetracaine HCl 3% and Oxymetazoline HCl 0.05% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment | (runny nose) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elliott V. Hersh, Principal Investigator | University of Pennsylvania School of Dental Medicine | 215-898-9686 | evhersh@pobox.upenn.edu |
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| ID | Term |
|---|---|
| D013748 | Tetracaine |
| ID | Term |
|---|---|
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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|
| Placebo | Drug | The placebo spray was identical in appearance to and was administered in the same volume and manner as the active ingredient. |
|
|
| 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 | at any time within 120 minutes following drug administration |
| Number of Participants With a Heart Rate Lower Than 50 Bpm | 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 | 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 | 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 | 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 | at any time within 120 minutes following study drug administration |
| Maximum Change From Baseline in Heart Rate | from baseline to 120 minutes following drug administration |
| Maximum Change From Baseline in Systolic Blood Pressure | from baseline to 120 minutes following drug administration |
| Maximum Change From Baseline in Diastolic Blood Pressure | from baseline to 120 minutes following drug administration |
| The Profile Over Time of Heart Rate | 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. | administered at approximately 24 hours after drug administration |
| The Profile Over Time of Systolic Blood Pressure | from baseline to 120 minutes following drug administration |
| The Profile Over Time of Diastolic Blood Pressure | from baseline to 120 minutes following drug administration |
| at 25 minutes, +3 minute window |
| University of Maryland, Baltimore |
| Baltimore |
| Maryland |
| 20740 |
| United States |
| University of Pennsylvania, School of Dental Medicine | Philadelphia | Pennsylvania | 19104 | United States |
Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Participants were only analyzed in their corresponding age group. | Posted | Number | percentage of participants | at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used |
|
|
|
| Secondary | Number of Participants With a Heart Rate Higher Than 125 Bpm | Posted | Number | participants | at any time within 120 minutes following drug administration |
|
|
|
| Secondary | Number of Participants With a Heart Rate Lower Than 50 Bpm | Posted | Number | participants | at any time within 120 minutes following drug administration |
|
|
|
| Secondary | 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 | Posted | Number | participants | at any time within 120 minutes following drug administration |
|
|
|
| Secondary | 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 | Posted | Number | participants | at any time within 120 minutes following study drug administration |
|
|
|
| Secondary | 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 | Posted | Number | participants | at any time within 120 minutes following study drug administration |
|
|
|
| Secondary | 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 | Posted | Number | participants | at any time within 120 minutes following study drug administration |
|
|
|
| Secondary | Maximum Change From Baseline in Heart Rate | Posted | Mean | Standard Deviation | bpm | from baseline to 120 minutes following drug administration |
|
|
|
| Secondary | Maximum Change From Baseline in Systolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | from baseline to 120 minutes following drug administration |
|
|
|
| Secondary | Maximum Change From Baseline in Diastolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | from baseline to 120 minutes following drug administration |
|
|
|
| Secondary | The Profile Over Time of Heart Rate | Posted | Mean | Standard Deviation | beats per minute | from baseline to 120 minutes following drug administration |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | cm | administered at approximately 24 hours after drug administration |
|
|
|
| Secondary | The Profile Over Time of Systolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | from baseline to 120 minutes following drug administration |
|
|
|
| Secondary | The Profile Over Time of Diastolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | from baseline to 120 minutes following drug administration |
|
|
|
| Other Pre-specified | Number of Participants Who Received Three Sprays and Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. | A participant will receive two sprays and Study Dental Procedure will begin. If the participant does not have sufficient anesthesia a third sprays will be given. If after the third spray, the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic. This outcome analyzes just the participants who received the third spray and whether or not they completed the Study Dental Procedure without need for rescue by injection of local anesthesia. | This analysis is only of the participants who received 3 sprays. It does not include participants who only received 2 sprays. | Posted | Number | participants | at 25 minutes, +3 minute window |
|
|
|
| 0 |
| 100 |
| 83 |
| 100 |
| EG001 | Placebo | Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered. Placebo | 0 | 50 | 15 | 50 |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment | (throat pain or discomfort) |
|
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment | (nasal stinging or burning sensation) |
|
| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment | (abnormal taste sensation) |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Lacrimation Increased | Eye disorders | MedDRA 15.0 | Systematic Assessment | (tearing or watery eyes) |
|
| Systolic BP Increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Diastolic BP Increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Intranasal Hypoaesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| greater than 50 |
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| 30 mins |
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| 45 mins |
|
| 60 mins |
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| 90 mins |
|
| 120 mins |
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| 30 mins |
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| 45 mins |
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| 60 mins |
|
| 90 mins |
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| 120 mins |
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| 30 mins |
|
| 45 mins |
|
| 60 mins |
|
| 90 mins |
|
| 120 mins |
|