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The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years

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ClinicalTrials.gov Identifier: NCT01363076
Recruitment Status : Completed
First Posted : June 1, 2011
Results First Posted : April 9, 2012
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):
Egalet Ltd

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Postoperative Pain
Intervention Drug: Ketorolac Tromethamine
Enrollment 20
Recruitment Details Recruitment Period: June 2007 - January 2008; Location: Stanford University Medical Center
Pre-assignment Details Screening procedure consisting of an interview and the following assessments: demographics, medical history, physical examination, concomitant medications within last 30 days, vital signs, clinical laboratory tests, pregnancy test (female subjects).
Arm/Group Title Ketorolac Tromethamine (15 mg) Ketorolac Tromethamine (30 mg)
Hide Arm/Group Description Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg. Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
Period Title: Overall Study
Started 7 13
Completed 7 12
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Ketorolac Tromethamine (15 mg) Ketorolac Tromethamine (30 mg) Total
Hide Arm/Group Description Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg. Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg. Total of all reporting groups
Overall Number of Baseline Participants 7 13 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 13 participants 20 participants
<=18 years
7
 100.0%
13
 100.0%
20
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 13 participants 20 participants
14.1  (0.7) 15.4  (1.6) 15.0  (1.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 13 participants 20 participants
Female
3
  42.9%
4
  30.8%
7
  35.0%
Male
4
  57.1%
9
  69.2%
13
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 13 participants 20 participants
7 13 20
1.Primary Outcome
Title Cmax (the Maximum Observed Plasma Concentration)
Hide Description Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.
Time Frame All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Tromethamine (15 mg) Ketorolac Tromethamine (30 mg)
Hide Arm/Group Description:
Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
Overall Number of Participants Analyzed 7 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
1153.9  (485.0) 1625.3  (538.5)
2.Primary Outcome
Title Tmax (The Time to Maximum Observed Plasma Concentration; ie. The Time at Which Cmax Occured)
Hide Description Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Pro. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. Individual plasma ketorolac concentrations were summarized by dose level for the PK population at each sampling time using n, arithmetic mean, SD, CV(%), geometric mean, 95% confidence intervals (CI) for the arithmetic mean, median, minimum, and maximum.
Time Frame All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Tromethamine (15 mg) Ketorolac Tromethamine (30 mg)
Hide Arm/Group Description:
Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
Overall Number of Participants Analyzed 7 13
Median (Full Range)
Unit of Measure: hr
0.720
(0.38 to 6.07)
0.780
(0.48 to 5.00)
3.Primary Outcome
Title AUClast (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint Post-dose)
Hide Description Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.
Time Frame All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Tromethamine (15 mg) Ketorolac Tromethamine (30 mg)
Hide Arm/Group Description:
Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
Overall Number of Participants Analyzed 7 13
Mean (Standard Deviation)
Unit of Measure: ng•h/mL
9308.2  (6214.2) 10662.1  (5383.5)
4.Primary Outcome
Title AUCinf (the AUC Time From Zero to Infinity, Where Possible)
Hide Description Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Pro. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. AUCinf calculated as: AUCinf = AUC(0-24) + (concentration at 24 hr/elimination constant).
Time Frame All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Tromethamine (15 mg) Ketorolac Tromethamine (30 mg)
Hide Arm/Group Description:
Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
Overall Number of Participants Analyzed 6 12
Mean (Standard Deviation)
Unit of Measure: ng•h/mL
10590.7  (7818.4) 11949.5  (6506.1)
5.Primary Outcome
Title AUC 0-24 (the AUC From Time Zero to 24 Hours Post-dose
Hide Description Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.
Time Frame All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Tromethamine (15 mg) Ketorolac Tromethamine (30 mg)
Hide Arm/Group Description:
Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
Overall Number of Participants Analyzed 7 12
Mean (Standard Deviation)
Unit of Measure: ng•h/mL
9600.5  (5959.9) 11317.2  (5666.1)
6.Primary Outcome
Title t1/2 (the Terminal Half-life, Where Possible)
Hide Description Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.
Time Frame All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Tromethamine (15 mg) Ketorolac Tromethamine (30 mg)
Hide Arm/Group Description:
Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
Overall Number of Participants Analyzed 6 12
Mean (Standard Deviation)
Unit of Measure: hr
6.678  (2.882) 5.031  (2.055)
7.Primary Outcome
Title MRT (Mean Residence Time)
Hide Description Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.
Time Frame All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Tromethamine (15 mg) Ketorolac Tromethamine (30 mg)
Hide Arm/Group Description:
Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
Overall Number of Participants Analyzed 6 12
Mean (Standard Deviation)
Unit of Measure: hr
9.664  (3.892) 6.727  (1.945)
Time Frame 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketorolac Tromethamine (15 mg) Ketorolac Tromethamine (30 mg)
Hide Arm/Group Description Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg. Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
All-Cause Mortality
Ketorolac Tromethamine (15 mg) Ketorolac Tromethamine (30 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ketorolac Tromethamine (15 mg) Ketorolac Tromethamine (30 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      1/13 (7.69%)    
Gastrointestinal disorders     
Vomiting  1  0/7 (0.00%)  0 1/13 (7.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ketorolac Tromethamine (15 mg) Ketorolac Tromethamine (30 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/7 (42.86%)      8/13 (61.54%)    
Gastrointestinal disorders     
Nausea  1  1/7 (14.29%)  1 1/13 (7.69%)  1
Vomiting  1  0/7 (0.00%)  0 2/13 (15.38%)  2
Injury, poisoning and procedural complications     
Procedural pain  1  0/7 (0.00%)  0 2/13 (15.38%)  2
Nervous system disorders     
Dysgeusia  1  0/7 (0.00%)  0 1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders     
Nasal discomfort  1  2/7 (28.57%)  2 1/13 (7.69%)  1
Rhinalgia  1  0/7 (0.00%)  0 1/13 (7.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: David Bregman, M.D., Ph.D.
Organization: Luitpold Pharmaceuticals, Inc.
Phone: 610-650-4200
Responsible Party: Egalet Ltd
ClinicalTrials.gov Identifier: NCT01363076     History of Changes
Other Study ID Numbers: ROX 2006-02
First Submitted: May 27, 2011
First Posted: June 1, 2011
Results First Submitted: March 8, 2012
Results First Posted: April 9, 2012
Last Update Posted: March 16, 2017