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Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply International
ClinicalTrials.gov Identifier:
NCT01591616
First received: June 24, 2011
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

To establish Oraqix is safe when used on adolescent volunteers.


Condition Intervention Phase
Periodontal Disease
Drug: lidocaine and prilocaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dentsply International:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 5, 10, 15, 30, 60, 90, 120, and 240 minutes ] [ Designated as safety issue: No ]
    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:
  • Safety [ Time Frame: blood draws pre-dose, 2 and 4 hours postdose ] [ Designated as safety issue: Yes ]

    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • ECGs (Ventricular Heart Rate) [ Time Frame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.


Enrollment: 16
Study Start Date: April 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591616

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

No publications provided

Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT01591616     History of Changes
Other Study ID Numbers: TP73
Study First Received: June 24, 2011
Results First Received: February 20, 2014
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
EMLA
Anesthetics
Anesthetics, Combined
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014