Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel

NCT01591616 | Completed Phase 4 Results

• 1 other identifier: TP73
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To establish Oraqix is safe when used on adolescent volunteers.

Conditions

Periodontal Disease

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  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).

  5, 10, 15, 30, 60, 90, 120, and 240 minutes

Secondary Outcomes (9)

• Safety

  blood draws pre-dose, 2 and 4 hours postdose

• Vital Signs (Pulse)

  Pre-dose and every 10 minute to 240 minutes post-dose.

• Vital Signs (Systolic Pressure)

  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)

  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)

  Pre-dose, 1 hour, 2 hour, 4 hour post-dose.

Study Arms (1)

Oraqix for tooth extraction

OTHER

Drug: lidocaine and prilocaine

Interventions

lidocaine and prilocaine DRUG

Appropriate dose of Oraqix based on weight will be given before tooth extraction

Also known as: Oraqix periodontal gel

Oraqix for tooth extraction

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dentsply International: lead

Study Sites (1)

Virginia Commonweath School of Dentistry

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Tegwyn H. Brickhouse, DDS, PhD
• Organization: Virginia Commonwealth University, School of Dentistry

thbrickhouse@vcu.edu

(804) 827-2699

Study Officials

• Tegwyn Brickhouse, D.D.S PhD

  Virginia Commonweath School of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: May 4, 2012
• Study Start: April 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 7, 2020
• Results First Posted: April 3, 2014

Record last verified: 2020-07

Locations

US (1)