Clinical trial NCT01591616: Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel
Official title: A Phase 4 Pediatric Study to Assess the Pharmacokinetics and Safety of Oraqix Gel in Healthy Children and Adolescent Volunteers Following Tooth Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontal Disease
Lead sponsor: Dentsply Sirona Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-04
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To establish Oraqix is safe when used on adolescent volunteers.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 6 and 17 and eleven twelfths
* requires tooth extraction
* healthy having not taken any prescription or over the counter medications within 60 days of first visit
* must be a minimum of 15 kg

Exclusion Criteria:

* anesthesia required for treatment other than study material
* given blood within 90 days of first visit
* pregnant
* allergic to local anesthetic
* documented history of glucose-6-phosphate dehydrogenase deficiency
* history of congenital idiopathic methemoglobinemia
* does not have a loose tooth easily extracted or who, in the opinion of the Investigator, is not suitable for tooth extraction using only topical anesthetic

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 5, 10, 15, 30, 60, 90, 120, and 240 minutes
Secondary outcomes:
measure: Safety
timeFrame: blood draws pre-dose, 2 and 4 hours postdose
measure: Vital Signs (Pulse)
timeFrame: Pre-dose and every 10 minute to 240 minutes post-dose.
measure: Vital Signs (Systolic Pressure)
timeFrame: Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
measure: Vital Signs (Diastolic Pressure)
timeFrame: Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose
measure: ECGs (Ventricular Heart Rate)
timeFrame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
measure: ECGs (PR Interval)
timeFrame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
measure: ECGs (QRS Duration)
timeFrame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
measure: ECGs (QT Interval)
timeFrame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
measure: ECGs (QTcB Interval)
timeFrame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonweath School of Dentistry
state: Virginia
Study officials:
affiliation: Virginia Commonweath School of Dentistry
name: Tegwyn Brickhouse, D.D.S PhD
role: PRINCIPAL_INVESTIGATOR
References: