Phase 4
N=16
Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel
Periodontal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01591616 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Pharmacokinetics — 89.9; 41.8; 3.72; 5.13 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- lidocaine and prilocaine (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Dentsply International
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics |
0.500; 0.500; 1.50; 1.50 | — |
| SECONDARY Safety |
1.3; 1.3; 1.2; 1.2; 1.3; 1.5 | — |
| SECONDARY Vital Signs (Pulse) |
74; 72; 72; 79; 71; 72 | — |
| SECONDARY Vital Signs (Systolic Pressure) |
110; 104; 106; 115; 109; 108 | — |
| SECONDARY Vital Signs (Diastolic Pressure) |
63; 60; 63; 69; 63; 64 | — |
| SECONDARY ECGs (Ventricular Heart Rate) |
73; 70; 71; 74 | — |
| SECONDARY ECGs (PR Interval) |
148; 147; 147; 139 | — |
| SECONDARY ECGs (QRS Duration) |
77; 76; 75; 74 | — |
| SECONDARY ECGs (QT Interval) |
376; 384; 383; 379 | — |
| SECONDARY ECGs (QTcB Interval) |
412; 413; 415; 419 | — |
Summary
To establish Oraqix is safe when used on adolescent volunteers.
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
Data sourced from ClinicalTrials.gov (NCT01591616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.