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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

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

Condition or disease Intervention/treatment Phase
Periodontal Disease Drug: lidocaine and prilocaine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 Start Date : April 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Oraqix for tooth extraction Drug: lidocaine and prilocaine
Appropriate dose of Oraqix based on weight will be given before tooth extraction
Other Name: Oraqix periodontal gel




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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. ]
  4. 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 ]
  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591616


Locations
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United States, Virginia
Virginia Commonweath School of Dentistry
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Dentsply International
Investigators
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Principal Investigator: Tegwyn Brickhouse, D.D.S PhD Virginia Commonweath School of Dentistry

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Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT01591616     History of Changes
Other Study ID Numbers: TP73
First Posted: May 4, 2012    Key Record Dates
Results First Posted: April 3, 2014
Last Update Posted: April 3, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Prilocaine
Lidocaine, Prilocaine Drug Combination
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Combined