Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Triligent International | INDUSTRY |
| Rho, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, 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.
A total of 140 subjects, randomized 2:2:1 (Kovacaine Mist:Tetracaine alone:Placebo) will be enrolled to achieve 125 completed subjects; a total of 50 Kovacaine Mist subjects, 50 tetracaine alone subjects and 25 placebo subjects. Recruitment will be from diverse dental patient populations. At the two study sites, a balanced enrollment of 70 subjects each is planned to allow for a potential 10% drop-out rate.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kovacaine Mist, 3 sprays unilateral | Experimental | Tetracaine HCl 3% and oxymetazoline HCl 0.05% |
|
| Tetracaine Only, 3 sprays unilateral | Experimental | Tetracaine HCl 3% |
|
| Placebo, 3 sprays unilateral | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetracaine HCl 3% and oxymetazoline HCl 0.05% | Drug | 3 unilateral intranasal sprays per dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no). | at 15 minutes with a 3 minute window |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoral Soft-tissue Anesthesia (Yes/no) | Number of patients who reported no pain when incisive papilla and greater palatine foramen soft-tissue was tested with a probe | at 15 minutes with a 3 minute window |
| Number of Participants With Heart Rate Higher Than 125 Bpm |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul A. Moore, DMD/PhD/MPH | University of Pittsburgh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore | Baltimore | Maryland | 20740 | United States | ||
| Family and Cosmetic Dentistry |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Kovacaine Mist, 3 Sprays Unilateral | Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose |
| FG001 | Tetracaine Only, 3 Sprays Unilateral | Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose |
| FG002 | Placebo, 3 Sprays Unilateral | Placebo Placebo: 3 unilateral intranasal sprays per dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Kovacaine Mist, 3 Sprays Unilateral | Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose |
| BG001 | Tetracaine Only, 3 Sprays Unilateral |
| 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 | Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no). | Posted | Count of Participants | Participants | at 15 minutes with a 3 minute window |
|
24 hours
Not provided
Not provided
| 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, 3 Sprays Unilateral | Tetracaine HCl 3% and oxymetazoline HCl 0.05% Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral discomfort | Gastrointestinal disorders | MedDRA (15.0) |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sharon M. Gordon | University of Maryland | 410-706-1656 | sgordon@dental.umaryland.edu |
Not provided
| ID | Term |
|---|---|
| D013748 | Tetracaine |
| ID | Term |
|---|---|
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tetracaine HCl 3% | Drug | 3 unilateral intranasal sprays per dose |
|
| Placebo | Drug | 3 unilateral intranasal sprays per dose |
|
| at any time within 120 minutes following drug administration |
| Number of Participants With 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 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 to a Value Lower Than 90 mm Hg | at any time within 120 minutes following drug administration |
| Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 90 mm Hg | at any time within 120 minutes following drug administration |
| Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg | at any time within 120 minutes following drug administration |
| Absolute Maximum Change From Baseline in Systolic Blood Pressure and 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 an alcohol swab. | 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 |
| Absolute Maximum Change From Baseline in Heart Rate | from baseline to 120 minutes following drug administration |
| Salt Lake City |
| Utah |
| 84124 |
| United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
Tetracaine HCl 3%
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose
| BG002 | Placebo, 3 Sprays Unilateral | Placebo Placebo: 3 unilateral intranasal sprays per dose |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo
Placebo: 3 unilateral intranasal sprays per dose
|
|
| Secondary | Intraoral Soft-tissue Anesthesia (Yes/no) | Number of patients who reported no pain when incisive papilla and greater palatine foramen soft-tissue was tested with a probe | Posted | Count of Participants | Participants | at 15 minutes with a 3 minute window |
|
|
|
| Secondary | Number of Participants With Heart Rate Higher Than 125 Bpm | Posted | Count of Participants | Participants | at any time within 120 minutes following drug administration |
|
|
|
| Secondary | Number of Participants With Heart Rate Lower Than 50 Bpm | Posted | Count of Participants | 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 to a Value Higher Than 160 mm Hg | Posted | Count of Participants | 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 to a Value Lower Than 90 mm Hg | Posted | Count of Participants | Participants | at any time within 120 minutes following drug administration |
|
|
|
| Secondary | Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 90 mm Hg | Posted | Count of Participants | Participants | at any time within 120 minutes following drug administration |
|
|
|
| Secondary | Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg | Posted | Count of Participants | Participants | at any time within 120 minutes following drug administration |
|
|
|
| Secondary | Absolute Maximum Change From Baseline in Systolic Blood Pressure and 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 | bpm | 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 an alcohol swab. | 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 |
|
|
|
| Secondary | Absolute Maximum Change From Baseline in Heart Rate | Posted | Mean | Standard Deviation | bpm | from baseline to 120 minutes following drug administration |
|
|
|
| 0 |
| 10 |
| 9 |
| 10 |
| EG001 | Tetracaine Only, 3 Sprays Unilateral | Tetracaine HCl 3% Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose | 0 | 10 | 10 | 10 |
| EG002 | Placebo, 3 Sprays Unilateral | Placebo Placebo: 3 unilateral intranasal sprays per dose | 0 | 6 | 6 | 6 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Runny nose |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Intranasal stinging or burning |
|
| Dysgeusia | Nervous system disorders | MedDRA (15.0) | Abnormal taste |
|
| Headache | Nervous system disorders | MedDRA (15.0) |
|
| Dizziness | Nervous system disorders | MedDRA (15.0) |
|
| Lacrimation increased | Eye disorders | MedDRA (15.0) | Tearing or watery eyes |
|
| Vision blurred | Eye disorders | MedDRA (15.0) |
|
| Hypoaesthesia eye | Eye disorders | MedDRA (15.0) | Numbness around eye |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA (15.0) |
|
| Pharyngeal Hypoaesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Intranasal Hypoaesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Anaesthetic Complication | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
Not provided
Not provided
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
|
|
|
| 30 Minutes |
|
| 45 Minutes |
|
| 60 Minutes |
|
| 90 Minutes |
|
| 120 Minutes |
|
|
| 30 Minutes |
|
| 45 Minutes |
|
| 60 Minutes |
|
| 90 Minutes |
|
| 120 Minutes |
|
|
| 30 Minutes |
|
| 45 Minutes |
|
| 60 Minutes |
|
| 90 Minutes |
|
| 120 Minutes |
|