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Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Periodontal Disease
Intervention Drug: lidocaine and prilocaine
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oraqix for Tooth Extraction
Hide Arm/Group Description lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
Period Title: Overall Study
Started 16
Completed 15
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Oraqix for Tooth Extraction
Hide Arm/Group Description lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
16
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
9
  56.3%
Male
7
  43.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Pharmacokinetics
Hide Description 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).
Time Frame 5, 10, 15, 30, 60, 90, 120, and 240 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Cmax Prilocaine Cmax 2,6-xylidine Cmax O-toluidine Cmax
Hide Arm/Group Description:
[Not Specified]
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Overall Number of Participants Analyzed 15 15 11 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
89.9
(66%)
41.8
(60.6%)
3.72
(48.5%)
5.13
(51.2%)
2.Primary Outcome
Title Pharmacokinetics
Hide Description 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).
Time Frame 5, 10, 15, 30, 60, 90, 120, and 240 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Tmax Prilocaine Tmax 2,6-xylidine Tmax O-toluidine Tmax
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
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Overall Number of Participants Analyzed 15 15 11 15
Geometric Mean (Full Range)
Unit of Measure: hours
0.500
(0.0833 to 0.650)
0.500
(0.0833 to 0.650)
1.50
(0.650 to 4.00)
1.50
(1.00 to 1.50)
3.Secondary Outcome
Title Safety
Hide Description

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.

Time Frame blood draws pre-dose, 2 and 4 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title % MetHemoglobin (MetHb) Time Point -20 Minutes % MetHemoglobin (MetHb) Time Point -10 Minutes % MetHemoglobin (MetHb) Time Point 0 Minutes % MetHemoglobin (MetHb) Time Point 10 Minutes % MetHemoglobin (MetHb) Time Point 20 Minutes % MetHemoglobin (MetHb) Time Point 30 Minutes % MetHemoglobin (MetHb) Time Point 40 Minutes % MetHemoglobin (MetHb) Time Point 50 Minutes % MetHemoglobin (MetHb) Time Point 60 Minutes % MetHemoglobin (MetHb) Time Point 70 Minutes % MetHemoglobin (MetHb) Time Point 80 Minutes % MetHemoglobin (MetHb) Time Point 90 Minutes % MetHemoglobin (MetHb) Time Point 100 Minutes % MetHemoglobin (MetHb) Time Point 110 Minutes % MetHemoglobin (MetHb) Time Point 120 Minutes % MetHemoglobin (MetHb) Time Point 130 Minutes % MetHemoglobin (MetHb) Time Point 140 Minutes % MetHemoglobin (MetHb) Time Point 150 Minutes % MetHemoglobin (MetHb) Time Point 160 Minutes % MetHemoglobin (MetHb) Time Point 170 Minutes % MetHemoglobin (MetHb) Time Point 180 Minutes % MetHemoglobin (MetHb) Time Point 190 Minutes % MetHemoglobin (MetHb) Time Point 200 Minutes % MetHemoglobin (MetHb) Time Point 210 Minutes % MetHemoglobin (MetHb) Time Point 220 Minutes % MetHemoglobin (MetHb) Time Point 230 Minutes % MetHemoglobin (MetHb) Time Point 240 Minutes
Hide Arm/Group Description:
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
Overall Number of Participants Analyzed 16 16 16 15 15 15 16 16 16 16 16 16 16 16 16 16 16 15 15 15 15 15 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: Percentage MetHb
1.3  (0.24) 1.3  (0.26) 1.2  (0.20) 1.2  (0.20) 1.3  (0.18) 1.5  (0.43) 1.5  (0.20) 1.6  (0.19) 1.7  (0.28) 1.7  (0.30) 1.5  (0.35) 1.5  (0.40) 1.5  (0.39) 1.6  (0.19) 1.5  (0.32) 1.5  (0.29) 1.4  (0.28) 1.4  (0.26) 1.3  (0.34) 1.2  (0.47) 1.4  (0.15) 1.4  (0.17) 1.5  (0.20) 1.4  (0.18) 1.4  (0.13) 1.5  (0.14) 1.4  (0.15)
4.Secondary Outcome
Title Vital Signs (Pulse)
Hide Description 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.
Time Frame Pre-dose and every 10 minute to 240 minutes post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vital Signs (Pulse Rate), - 20 Minutes Pre-dose Vital Signs (Pulse Rate), - 10 Minutes Pre-dose Vital Signs (Pulse Rate), 0 Minutes Pre-dose Vital Signs (Pulse Rate), 10 Minutes Post-dose Vital Signs (Pulse Rate), 20 Minutes Post-dose Vital Signs (Pulse Rate), 30 Minutes Post-dose Vital Signs (Pulse Rate), 40 Minutes Post-dose Vital Signs (Pulse Rate), 50 Minutes Post-dose Vital Signs (Pulse Rate), 60 Minutes Post-dose Vital Signs (Pulse Rate), 70 Minutes Post-dose Vital Signs (Pulse Rate), 80 Minutes Post-dose Vital Signs (Pulse Rate), 90 Minutes Post-dose Vital Signs (Pulse Rate), 100 Minutes Post-dose Vital Signs (Pulse Rate), 110 Minutes Post-dose Vital Signs (Pulse Rate), 120 Minutes Post-dose Vital Signs (Pulse Rate), 130 Minutes Post-dose Vital Signs (Pulse Rate), 140 Minutes Post-dose Vital Signs (Pulse Rate), 150 Minutes Post-dose Vital Signs (Pulse Rate), 160 Minutes Post-dose Vital Signs (Pulse Rate), 170 Minutes Post-dose Vital Signs (Pulse Rate), 180 Minutes Post-dose Vital Signs (Pulse Rate), 190 Minutes Post-dose Vital Signs (Pulse Rate), 200 Minutes Post-dose Vital Signs (Pulse Rate), 210 Minutes Post-dose Vital Signs (Pulse Rate), 220 Minutes Post-dose Vital Signs (Pulse Rate), 230 Minutes Post-dose Vital Signs (Pulse Rate), 240 Minutes Post-dose
Hide Arm/Group Description:
[Not Specified]
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Overall Number of Participants Analyzed 16 16 16 15 14 14 16 16 16 16 16 16 16 16 16 16 16 15 15 15 15 15 15 15 15 15 15
Mean (Full Range)
Unit of Measure: Beats per minute
74
(58 to 98)
72
(54 to 90)
72
(60 to 95)
79
(59 to 101)
71
(58 to 89)
72
(56 to 94)
71
(55 to 86)
70
(54 to 86)
71
(55 to 86)
74
(61 to 89)
72
(57 to 86)
71
(53 to 90)
70
(54 to 91)
72
(57 to 88)
70
(52 to 86)
71
(58 to 91)
72
(53 to 97)
72
(55 to 98)
74
(58 to 93)
74
(57 to 100)
73
(53 to 91)
72
(50 to 90)
75
(62 to 90)
72
(54 to 97)
70
(53 to 96)
72
(57 to 96)
77
(62 to 101)
5.Secondary Outcome
Title Vital Signs (Systolic Pressure)
Hide Description [Not Specified]
Time Frame Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vital Signs (Systolic), - 20 Minutes Pre-dose Vital Signs (Systolic), - 10 Minutes Pre-dose Vital Signs (Systolic), 0 Minutes Pre-dose Vital Signs (Systolic), 10 Minutes Post-dose Vital Signs (Systolic), 20 Minutes Post-dose Vital Signs (Systolic), 30 Minutes Post-dose Vital Signs (Systolic), 40 Minutes Post-dose Vital Signs (Systolic), 50 Minutes Post-dose Vital Signs (Systolic), 60 Minutes Post-dose Vital Signs (Systolic), 70 Minutes Post-dose Vital Signs (Systolic) 80 Minutes Post-dose Vital Signs (Systolic), 90 Minutes Post-dose Vital Signs (Systolic), 100 Minutes Post-dose Vital Signs (Systolic), 110 Minutes Post-dose Vital Signs (Systolic), 120 Minutes Post-dose Vital Signs (Systolic), 130 Minutes Post-dose Vital Signs (Systolic), 140 Minutes Post-dose Vital Signs (Systolic), 150 Minutes Post-dose Vital Signs (Systolic), 160 Minutes Post-dose Vital Signs (Systolic), 170 Minutes Post-dose Vital Signs (Systolic), 180 Minutes Post-dose Vital Signs (Systolic), 190 Minutes Post-dose Vital Signs (Systolic), 200 Minutes Post-dose Vital Signs (Systolic), 210 Minutes Post-dose Vital Signs (Systolic), 220 Minutes Post-dose Vital Signs (Systolic), 230 Minutes Post-dose Vital Signs (Systolic), 240 Minutes Post-dose
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
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Overall Number of Participants Analyzed 16 16 16 15 14 14 16 16 16 16 16 16 16 16 16 16 16 15 15 15 15 15 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: mmHg
110  (11.5) 104  (9.4) 106  (9.1) 115  (9.7) 109  (7.9) 108  (9.4) 106  (9.8) 106  (9.6) 105  (12.1) 106  (7.9) 104  (11.0) 106  (9.7) 106  (9.9) 106  (10.7) 106  (11.4) 105  (8.9) 108  (8.0) 107  (8.4) 105  (10.7) 106  (9.6) 104  (10.2) 103  (10.7) 103  (10.9) 102  (9.2) 104  (10.8) 102  (10.6) 102  (11.7)
6.Secondary Outcome
Title Vital Signs (Diastolic Pressure)
Hide Description [Not Specified]
Time Frame Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vital Signs (Diastolic), - 20 Minutes Pre-dose Vital Signs (Diastolic), - 10 Minutes Pre-dose Vital Signs (Diastolic), 0 Minutes Pre-dose Vital Signs (Diastolic), 10 Minutes Post-dose Vital Signs (Diastolic), 20 Minutes Post-dose Vital Signs (Diastolic), 30 Minutes Post-dose Vital Signs (Diastolic), 40 Minutes Post-dose Vital Signs (Diastolic), 50 Minutes Post-dose Vital Signs Diastolic(), 60 Minutes Post-dose Vital Signs (Diastolic), 70 Minutes Post-dose Vital Signs (Diastolic) 80 Minutes Post-dose Vital Signs (Diastolic), 90 Minutes Post-dose Vital Signs (Diastolic), 100 Minutes Post-dose Vital Signs (Diastolic), 110 Minutes Post-dose Vital Signs (Diastolic), 120 Minutes Post-dose Vital Signs Diastolic(), 130 Minutes Post-dose Vital Signs (Diastolic), 140 Minutes Post-dose Vital Signs (Diastolic), 150 Minutes Post-dose Vital Signs (Diastolic), 160 Minutes Post-dose Vital Signs (Diastolic), 170 Minutes Post-dose Vital Signs (Diastolic), 180 Minutes Post-dose Vital Signs (Diastolic), 190 Minutes Post-dose Vital Signs (Diastolic), 200 Minutes Post-dose Vital Signs (Diastolic), 210 Minutes Post-dose Vital Signs (Diastolic), 220 Minutes Post-dose Vital Signs (Diastolic), 230 Minutes Post-dose Vital Signs (Diastolic), 240 Minutes Post-dose
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
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Overall Number of Participants Analyzed 16 16 16 15 14 14 16 16 16 16 16 16 16 16 16 16 16 16 15 15 15 15 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: mmHg
63  (6.8) 60  (7.2) 63  (7.2) 69  (7.9) 63  (6.2) 64  (5.6) 62  (8.7) 62  (11.2) 62  (7.7) 62  (10.8) 62  (9.3) 64  (7.6) 63  (7.6) 63  (11.4) 60  (7.6) 62  (7.9) 62  (7.2) 63  (9.1) 63  (6.6) 60  (6.8) 60  (8.8) 61  (7.1) 60  (7.6) 59  (7.5) 57  (6.9) 57  (6.9) 60  (8.4)
7.Secondary Outcome
Title ECGs (Ventricular Heart Rate)
Hide Description Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Time Frame Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ventricular Heart Rate, Pre-dose Ventricular Heart Rate, 1 Hour Post-dose Ventricular Heart Rate, 2 Hour Post-dose Ventricular Heart Rate, 4 Hour Post-dose
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
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Overall Number of Participants Analyzed 15 15 15 16
Mean (Standard Deviation)
Unit of Measure: Beats per minute
73  (9.9) 70  (8.3) 71  (6.5) 74  (10.1)
8.Secondary Outcome
Title ECGs (PR Interval)
Hide Description Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Time Frame Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PR Interval, Pre-dose PR Interval, 1 Hour Post-dose PR Interval, 2 Hour Post-dose PR Interval, 4 Hour Post-dose
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
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Overall Number of Participants Analyzed 15 15 15 16
Mean (Standard Deviation)
Unit of Measure: milliseconds
148  (21.1) 147  (23.7) 147  (22.4) 139  (18.9)
9.Secondary Outcome
Title ECGs (QRS Duration)
Hide Description Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Time Frame Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title QRS Duration, Pre-dose QRS Duration, 1 Hour Post-dose QRS Duration, 2 Hour Post-dose QRS Duration, 4 Hour Post-dose
Hide Arm/Group Description:
[Not Specified]
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Overall Number of Participants Analyzed 15 15 15 16
Mean (Standard Deviation)
Unit of Measure: milliseconds
77  (5.7) 76  (4.5) 75  (7.5) 74  (5.3)
10.Secondary Outcome
Title ECGs (QT Interval)
Hide Description Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Time Frame Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title QT Interval, Pre-dose QT Interval, 1 Hour Post-dose QT Interval, 2 Hour Post-dose QT Interval, 4 Hour Post-dose
Hide Arm/Group Description:
[Not Specified]
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Overall Number of Participants Analyzed 15 15 15 16
Mean (Standard Deviation)
Unit of Measure: milliseconds
376  (22.5) 384  (19.3) 383  (19.0) 379  (25.8)
11.Secondary Outcome
Title ECGs (QTcB Interval)
Hide Description Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Time Frame Pre-dose, 1 hour, 2 hour, 4 hour post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title QTcB Interval, Pre-dose QTcB Interval, 1 Hour Post-dose QTcB Interval, 2 Hour Post-dose QTcB Interval, 4 Hour Post-dose
Hide Arm/Group Description:
[Not Specified]
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Overall Number of Participants Analyzed 15 15 15 16
Mean (Standard Deviation)
Unit of Measure: milliseconds
412  (19.0) 413  (21.9) 415  (18.6) 419  (21.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adverse Events
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Adverse Events
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adverse Events
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adverse Events
Affected / at Risk (%)
Total   2/16 (12.50%) 
Gastrointestinal disorders   
Nausea   2/16 (12.50%) 
Gagging   1/16 (6.25%) 
Vomiting   1/16 (6.25%) 
Nervous system disorders   
Tooth pain   1/16 (6.25%) 
Headache   1/16 (6.25%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The subject study was a post-approval requirement related to the approval of NDA 21-451 to evaluate the pharmacokinetics and safety of the Oraqix gel in pediatric patients. As the purpose of the study was solely to fulfill a post approval regulatory requirement, the information is considered proprietary to the sponsor (Dentsply International, Inc.) and disclosure by the Investigators to any third party (unless such disclosure was required by government regulations or laws) was prohibited.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tegwyn H. Brickhouse, DDS, PhD
Organization: Virginia Commonwealth University, School of Dentistry
Phone: (804) 827-2699
EMail: thbrickhouse@vcu.edu
Layout table for additonal information
Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT01591616     History of Changes
Other Study ID Numbers: TP73
First Submitted: June 24, 2011
First Posted: May 4, 2012
Results First Submitted: February 20, 2014
Results First Posted: April 3, 2014
Last Update Posted: April 3, 2014