Periodontal DiseasePhase 4NCT01591616
Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel
A Phase 4 study testing lidocaine and prilocaine in people with Periodontal Disease, run by Dentsply International at 1 site in United States.
Trial summary
To establish Oraqix is safe when used on adolescent volunteers. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- lidocaine and prilocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonweath School of Dentistry
Richmond, Virginia, 23298
About this study
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
To establish Oraqix is safe when used on adolescent volunteers.
Read the 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.
- Conditions
- Periodontal Disease
- Being tested
- lidocaine and prilocaine
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine and prilocaineDrug
Also called Oraqix periodontal gel
Appropriate dose of Oraqix based on weight will be given before tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Oraqix for tooth extraction | Other | Not described Receives: Drug: lidocaine and prilocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5, 10, 15, 30, 60, 90, 120, and 240 minutes
Secondary outcomes (9)
Safety
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.
Measured: blood draws pre-dose, 2 and 4 hours postdose
Vital Signs (Pulse)
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.
Measured: Pre-dose and every 10 minute to 240 minutes post-dose.
Vital Signs (Systolic Pressure)
Measured: 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)
Measured: 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)
Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Measured: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
ECGs (PR Interval)
Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Measured: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
ECGs (QRS Duration)
Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Measured: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
ECGs (QT Interval)
Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Measured: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
ECGs (QTcB Interval)
Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Measured: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startApr 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tegwyn Brickhouse, D.D.S PhD, Principal investigator, Virginia Commonweath School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591616
- Sponsor's protocol ID
- TP73
- Status last verified
- Jul 2020
- First submitted
- 24 Jun 2011
- Last updated
- 7 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01591616
- Acronym / sponsor ID
- TP73
- Conditions
- Periodontal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Dentsply InternationalIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 4 May 2012 (estimated)
- Results
- Posted 3 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oraqix for tooth extraction | Other | Drug: lidocaine and prilocaine |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine and prilocaineAlso: Oraqix periodontal gelAppropriate dose of Oraqix based on weight will be given before tooth extraction | Drug | Oraqix for tooth extraction |
Primary outcome
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).
9 secondary outcomes
Safety
Time frame: blood draws pre-dose, 2 and 4 hours postdose
Vital Signs (Pulse)
Time frame: Pre-dose and every 10 minute 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.
ECGs (PR Interval)
Time frame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
ECGs (QRS Duration)
Time frame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
ECGs (QT Interval)
Time frame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
ECGs (QTcB Interval)
Time frame: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tegwyn Brickhouse, D.D.S PhD principal investigator
Virginia Commonweath School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lidocaine and prilocaine in people with Periodontal Disease, run by Dentsply International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (time frame: 5, 10, 15, 30, 60, 90, 120, and 240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.