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To establish Oraqix is safe when used on adolescent volunteers.
This is a single-center, uncontrolled, open-label, single administration patient study. Male and female subjects aged 6 through 17 years of age in need of primary tooth extraction will be recruited from the Principal Investigator's database and may be supplemented by advertising. Subjects who withdraw from the study prematurely will be replaced.
Subjects will undergo an initial screening visit at which eligibility will be determined. After completion of informed consent/assent a physical examination, vitals, 12-lead ECG, and dental examination will be conducted. A medical history will be documented and a blood sample will be collected for analysis of biochemistry, hematology and as appropriate, serum pregnancy assessment for females.
Subjects will return to the office approximately 1 to 10 days after Visit 1 for Visit 2. At Visit 2, study treatment will be administered and PK blood samples will be collected for analysis, and monitored for safety parameters. Up to a total of five cartridges of Oraqix® will be administered to the oral cavity in the area of the tooth extraction, based on the body weight of the subject. No more than five cartridges will be dispensed, since this is the maximum dose for this agent. The final sample will be collected 4 hours after administration of study material. An abbreviated dental examination will be conducted, any adverse events (AEs) will be documented and the subject will be discharged from the clinic.
All subjects will be contacted by telephone approximately 24 hours after administration of study treatment. Study personnel will enquire about the occurrence of any AEs that have occurred since leaving the office. If appropriate, further follow-up of AEs will be arranged. In the absence of any ongoing AEs requiring follow up the subject will be considered to have completed the study at the completion of the telephone call.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oraqix for tooth extraction | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine and prilocaine | Drug | Appropriate dose of Oraqix based on weight will be given before tooth extraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration). | 5, 10, 15, 30, 60, 90, 120, and 240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | The % MetHb levels and vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose. ECG taken at pre-dose and 1, 2 and 4h post dose, measurement of heart rate and PR, QRS, QT and QTcB intervals. Visual analogue scale conducted at pre-dose (immediately before Oraqix administration), immed. post extraction, at 0.25, 0.5, 1 and 2h post dose and prior to discharge just after 4h post dose. For each subject, phone call was made at +24h as follow up pursuant to the protocol. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tegwyn Brickhouse, D.D.S PhD | Virginia Commonweath School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonweath School of Dentistry | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oraqix for Tooth Extraction | lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oraqix for Tooth Extraction | lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Pharmacokinetics | The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 5, 10, 15, 30, 60, 90, 120, and 240 minutes |
|
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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 | Adverse Events |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tegwyn H. Brickhouse, DDS, PhD | Virginia Commonwealth University, School of Dentistry | (804) 827-2699 | thbrickhouse@vcu.edu |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 |
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| blood draws pre-dose, 2 and 4 hours postdose |
| Vital Signs (Pulse) | Vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose. | Pre-dose and every 10 minute to 240 minutes post-dose. |
| Vital Signs (Systolic Pressure) | Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose. |
| Vital Signs (Diastolic Pressure) | Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose |
| ECGs (Ventricular Heart Rate) | Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. | Pre-dose, 1 hour, 2 hour, 4 hour post-dose. |
| ECGs (PR Interval) | Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. | Pre-dose, 1 hour, 2 hour, 4 hour post-dose. |
| ECGs (QRS Duration) | Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. | Pre-dose, 1 hour, 2 hour, 4 hour post-dose. |
| ECGs (QT Interval) | Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. | Pre-dose, 1 hour, 2 hour, 4 hour post-dose. |
| ECGs (QTcB Interval) | Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. | Pre-dose, 1 hour, 2 hour, 4 hour post-dose. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | O-toluidine Cmax |
|
|
| Secondary | Safety | The % MetHb levels and vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose. ECG taken at pre-dose and 1, 2 and 4h post dose, measurement of heart rate and PR, QRS, QT and QTcB intervals. Visual analogue scale conducted at pre-dose (immediately before Oraqix administration), immed. post extraction, at 0.25, 0.5, 1 and 2h post dose and prior to discharge just after 4h post dose. For each subject, phone call was made at +24h as follow up pursuant to the protocol. | Posted | Mean | Standard Deviation | Percentage MetHb | blood draws pre-dose, 2 and 4 hours postdose |
|
|
|
| Primary | Pharmacokinetics | The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration). | Posted | Geometric Mean | Full Range | hours | 5, 10, 15, 30, 60, 90, 120, and 240 minutes |
|
|
|
| Secondary | Vital Signs (Pulse) | Vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose. | Posted | Mean | Full Range | Beats per minute | Pre-dose and every 10 minute to 240 minutes post-dose. |
|
|
|
| Secondary | Vital Signs (Systolic Pressure) | Posted | Mean | Standard Deviation | mmHg | Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose. |
|
|
|
| Secondary | Vital Signs (Diastolic Pressure) | Posted | Mean | Standard Deviation | mmHg | Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose |
|
|
|
| Secondary | ECGs (Ventricular Heart Rate) | Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. | Posted | Mean | Standard Deviation | Beats per minute | Pre-dose, 1 hour, 2 hour, 4 hour post-dose. |
|
|
|
| Secondary | ECGs (PR Interval) | Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. | Posted | Mean | Standard Deviation | milliseconds | Pre-dose, 1 hour, 2 hour, 4 hour post-dose. |
|
|
|
| Secondary | ECGs (QRS Duration) | Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. | Posted | Mean | Standard Deviation | milliseconds | Pre-dose, 1 hour, 2 hour, 4 hour post-dose. |
|
|
|
| Secondary | ECGs (QT Interval) | Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. | Posted | Mean | Standard Deviation | milliseconds | Pre-dose, 1 hour, 2 hour, 4 hour post-dose. |
|
|
|
| Secondary | ECGs (QTcB Interval) | Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated. | Posted | Mean | Standard Deviation | milliseconds | Pre-dose, 1 hour, 2 hour, 4 hour post-dose. |
|
|
|
| 0 |
| 16 |
| 2 |
| 16 |
| Gagging | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Tooth pain | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
The subject study was a post-approval requirement related to the approval of NDA 21-451 to evaluate the pharmacokinetics and safety of the Oraqix gel in pediatric patients. As the purpose of the study was solely to fulfill a post approval regulatory requirement, the information is considered proprietary to the sponsor (Dentsply International, Inc.) and disclosure by the Investigators to any third party (unless such disclosure was required by government regulations or laws) was prohibited.
| Organic Chemicals |
| D011318 | Prilocaine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |