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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 pediatric patients.
The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to demonstrate the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary permanent teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) or maxillary primary teeth numbers A to J (maxillary right second primary molar to maxillary left second primary molar) sufficient to allow completion of the Study Dental Procedure. The maxillary teeth will be categorized in two subsets, anterior teeth (permanent teeth numbers 6 to 11 and primary teeth numbers C to H) and posterior teeth (permanent teeth numbers 4, 5, 12, 13 and primary teeth numbers A, B, I, J).
The intent is to treat 90 male and female subjects aged 3 to 17 years, inclusive, at 3 study sites, 2:1 randomization within each study site, and an overall goal of 60 subjects treated with Kovacaine Mist and 30 treated with placebo. Subjects will receive Kovacaine Mist or placebo (2:1) according to the kit randomization plan within three dosing strata (100 µL, 200 µL or 400 µL) based on subject weight at entry: subjects weighing 10 to <20 kg, 20 to <40 kg and ≥ 40 kg will be assigned to the 100 µL, 200 µL or 400 µL dose group, respectively. Recruitment will be from diverse pediatric dental patient populations. To ensure adequate representation in the 3 dose/weight groups, each stratum will contain at least 25% of subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kovacaine Mist | Experimental | Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total); |
|
| Placebo | Placebo Comparator | Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total); |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetracaine HCl 3% and Oxymetazoline HCl 0.05% | Drug | Intranasally administered regional anesthetic |
|
| 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. | 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - 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 Dosage Cohort. | 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. | 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Kovacaine Mist | Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total); Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic |
| FG001 | Placebo | Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total); Placebo: Inactive ingredients supplied in identical nasal sprayer |
| 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% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total); Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic |
| 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 | Count of Participants | Participants | 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window |
|
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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% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total); Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yiming Li, DDS | Loma Linda University | 909-558-4600 | kkellingsworth@llu.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 | Inactive ingredients supplied in identical nasal sprayer |
|
|
| Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. by Age Group (3-5, 6-11, and 12-17 Years Old, Inclusive). | 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. | 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window |
| Incidence of Adverse Events (AEs) by Dosage Cohort | Patients with AEs | from baseline to 24 hours following drug administration |
| Incidence of Adverse Events (AEs) by Age Group | Patients with AEs | from baseline to 24 hours following drug administration |
| Results of Naris Examination (NE) - Patency and Ulcerations | The investigators evaluated the treatment naris for patency and ulcerations. Patency was evaluated as followed: The nostril not used for dosing study drug was manually occluded and the subject was asked to sniff gently. Airflow in the naris was used to determine if it was patent (yes) or not (no). For ulcers, the investigators performed a visual examination for the presence of ulcers and recorded if they were present (yes) or not (no). | 120 minutes post drug administration |
| Maximum Change From Baseline in Heart Rate | from baseline to 24 hours following drug administration |
| Maximum Change From Baseline in Systolic Blood Pressure | from baseline to 24 hours following drug administration |
| Maximum Change From Baseline in Diastolic Blood Pressure | from baseline to 24 hours following drug administration |
| Results of Naris Examination (NE) - Color | The investigators performed a visual inspection and evaluated the treatment naris for color of the mucosa. The investigator determined what color (Pink, Slightly Red, Red) best matched and recorded the results. | 120 minutes post drug administration |
| Results of Naris Examination (NE) - Inflammation | 120 minutes post drug administration |
| Results of Naris Examination (NE) - Bleeding | 120 minutes post drug administration |
| Big Grins |
| Fort Collins |
| Colorado |
| 80525 |
| United States |
| BG001 | Placebo | Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total); Placebo: Inactive ingredients supplied in identical nasal sprayer |
| BG002 | 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 |
|
| OG001 | Placebo | Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total); Placebo: Inactive ingredients supplied in identical nasal sprayer |
|
|
| Secondary | Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.by Dosage Cohort. | 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. | Subjects were in only 1 of 3 dosage cohort. Either 100 µL, 200 µL, or 400 µL. | Posted | Count of Participants | Participants | 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window |
|
|
|
| Secondary | Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. by Age Group (3-5, 6-11, and 12-17 Years Old, Inclusive). | 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. | Patients are grouped by age | Posted | Count of Participants | Participants | 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window |
|
|
|
| Secondary | Incidence of Adverse Events (AEs) by Dosage Cohort | Patients with AEs | Patients grouped by dosage cohort | Posted | Number | Count of participants | from baseline to 24 hours following drug administration |
|
|
|
| Secondary | Incidence of Adverse Events (AEs) by Age Group | Patients with AEs | Patients group by age | Posted | Number | Count of participants | from baseline to 24 hours following drug administration |
|
|
|
| Secondary | Results of Naris Examination (NE) - Patency and Ulcerations | The investigators evaluated the treatment naris for patency and ulcerations. Patency was evaluated as followed: The nostril not used for dosing study drug was manually occluded and the subject was asked to sniff gently. Airflow in the naris was used to determine if it was patent (yes) or not (no). For ulcers, the investigators performed a visual examination for the presence of ulcers and recorded if they were present (yes) or not (no). | Posted | Count of Participants | Participants | 120 minutes post drug administration |
|
|
|
| Secondary | Maximum Change From Baseline in Heart Rate | Posted | Mean | Standard Deviation | bpm | from baseline to 24 hours following drug administration |
|
|
|
| Secondary | Maximum Change From Baseline in Systolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | from baseline to 24 hours following drug administration |
|
|
|
| Secondary | Maximum Change From Baseline in Diastolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | from baseline to 24 hours following drug administration |
|
|
|
| Secondary | Results of Naris Examination (NE) - Color | The investigators performed a visual inspection and evaluated the treatment naris for color of the mucosa. The investigator determined what color (Pink, Slightly Red, Red) best matched and recorded the results. | Posted | Count of Participants | Participants | 120 minutes post drug administration |
|
|
|
| Secondary | Results of Naris Examination (NE) - Inflammation | Posted | Count of Participants | Participants | 120 minutes post drug administration |
|
|
|
| Secondary | Results of Naris Examination (NE) - Bleeding | Posted | Count of Participants | Participants | 120 minutes post drug administration |
|
|
|
| 0 |
| 60 |
| 40 |
| 60 |
| EG001 | Placebo | Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total); Placebo: Inactive ingredients supplied in identical nasal sprayer | 0 | 30 | 18 | 30 |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | (runny nose) |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | (stinging or burning sensation) |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | Systematic Assessment | (tearing or watery eyes) |
|
| Pharyngeal Hypoaesthesia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Injection Site Pain | General disorders | Systematic Assessment |
|
| Injection Site Anaesthesia | General disorders | Systematic Assessment |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| 200 µL |
|
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| 400 µL |
|
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| 6 to 11 years |
|
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| 12 to 17 years |
|
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| 200 µL |
|
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| 400 µL |
|
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| 6 to 11 years |
|
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| 12 to 17 years |
|
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| Red |
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| Inflammation |
|
| Significant / Major |
|