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Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel

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ClinicalTrials.gov Identifier: NCT01591616
Recruitment Status : Completed
First Posted : May 4, 2012
Results First Posted : April 3, 2014
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):
Dentsply International

Tracking Information
First Submitted Date  ICMJE June 24, 2011
First Posted Date  ICMJE May 4, 2012
Results First Submitted Date  ICMJE February 20, 2014
Results First Posted Date  ICMJE April 3, 2014
Last Update Posted Date April 3, 2014
Study Start Date  ICMJE April 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2014)
Pharmacokinetics [ Time Frame: 5, 10, 15, 30, 60, 90, 120, and 240 minutes ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
Pharmacokinetics [ Time Frame: 5, 10, 15, 30, 60, 90 and 120 minutes ]
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
Change History Complete list of historical versions of study NCT01591616 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2014)
  • Safety [ Time Frame: blood draws pre-dose, 2 and 4 hours postdose ]
    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.
  • Vital Signs (Pulse) [ Time Frame: Pre-dose and every 10 minute to 240 minutes post-dose. ]
    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.
  • Vital Signs (Systolic Pressure) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose. ]
    Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
  • ECGs (PR Interval) [ Time Frame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose. ]
    Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
  • ECGs (QRS Duration) [ Time Frame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose. ]
    Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
  • ECGs (QT Interval) [ Time Frame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose. ]
    Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
  • ECGs (QTcB Interval) [ Time Frame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose. ]
    Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
Safety [ Time Frame: blood draws pre-dose, 2 and 4 hours postdose ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel
Official Title  ICMJE A Phase 4 Pediatric Study to Assess the Pharmacokinetics and Safety of Oraqix Gel in Healthy Children and Adolescent Volunteers Following Tooth Extraction
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Periodontal Disease
Intervention  ICMJE Drug: lidocaine and prilocaine
Appropriate dose of Oraqix based on weight will be given before tooth extraction
Other Name: Oraqix periodontal gel
Study Arms  ICMJE Oraqix for tooth extraction
Intervention: Drug: lidocaine and prilocaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2014)
16
Original Actual Enrollment  ICMJE
 (submitted: May 2, 2012)
15
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01591616
Other Study ID Numbers  ICMJE TP73
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dentsply International
Study Sponsor  ICMJE Dentsply International
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tegwyn Brickhouse, D.D.S PhD Virginia Commonweath School of Dentistry
PRS Account Dentsply International
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP