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Trial record 96 of 463 for:    KETOROLAC

Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01365611
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : April 30, 2013
Last Update Posted : March 15, 2017
Sponsor:
Information provided by:
Egalet Ltd

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy Subjects
Interventions Drug: Ketorolac tromethamine
Drug: Fluticasone Propionate
Enrollment 36
Recruitment Details February 7, 2007 - May 22, 2007; Clinical Unit
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description

A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.

Subjects received a single daily intranasal dose of 200mg fluticasone propionate on Days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.

Period Title: Overall Study
Started 36
Completed 36
Not Completed 0
Arm/Group Title All Study Participants
Hide Arm/Group Description A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6. Subjects received a single daily intranasal dose of 200mg fluticasone propionate on Days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
<=18 years
1
   2.8%
Between 18 and 65 years
35
  97.2%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
33.7  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
10
  27.8%
Male
26
  72.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 36 participants
36
1.Primary Outcome
Title Cmax (the Maximum Observed Plasma Concentration of Ketorolac Tromethamine)
Hide Description [Not Specified]
Time Frame PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Tromethamine (Given Alone) Fluticasone Propionate + Ketorolac Tromethamine
Hide Arm/Group Description:
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: ng/mL
2128  (1042.5) 1948  (1018.3)
2.Primary Outcome
Title Tmax (the Time to Maximum Concentration of Ketorolac Tromethamine)
Hide Description [Not Specified]
Time Frame PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Tromethamine (Given Alone) Fluticasone Propionate + Ketorolac Tromethamine
Hide Arm/Group Description:
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
Overall Number of Participants Analyzed 36 36
Median (Full Range)
Unit of Measure: hours
0.750
(0.25 to 1.00)
0.750
(0.25 to 1.00)
3.Primary Outcome
Title AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose of Ketorolac Tromethamine).
Hide Description [Not Specified]
Time Frame PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Tromethamine (Given Alone) Fluticasone Propionate + Ketorolac Tromethamine
Hide Arm/Group Description:
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: ng*hours/mL
7991  (4364.2) 7610  (4076.8)
4.Primary Outcome
Title AUC Inf (the AUC From Time Zero to Infinity, Where Possible)
Hide Description [Not Specified]
Time Frame PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
The half-life could not be estimated for a subject due to the nature of the subject's PK profile.
Arm/Group Title Ketorolac Tromethamine (Given Alone) Fluticasone Propionate + Ketorolac Tromethamine
Hide Arm/Group Description:
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
Overall Number of Participants Analyzed 35 36
Mean (Standard Deviation)
Unit of Measure: ng*hours/mL
8970  (4575) 8276  (4380.7)
5.Primary Outcome
Title t1/2z (the Terminal Half-life of Ketorolac Tromethamine, Where Possible)
Hide Description [Not Specified]
Time Frame PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
The half-life could not be estimated for a subject due to the nature of the subject's PK profile.
Arm/Group Title Ketorolac Tromethamine (Given Alone) Fluticasone Propionate + Ketorolac Tromethamine
Hide Arm/Group Description:
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
Overall Number of Participants Analyzed 35 36
Mean (Standard Deviation)
Unit of Measure: hours
5.95  (2.105) 5.49  (2.004)
6.Primary Outcome
Title MRT (the Mean Residence Time of Ketorolac Tromethamine, Where Possible)
Hide Description [Not Specified]
Time Frame PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
The half-life could not be estimated for a subject due to the nature of the subject's PK profile.
Arm/Group Title Ketorolac Tromethamine (Given Alone) Fluticasone Propionate + Ketorolac Tromethamine
Hide Arm/Group Description:
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
Overall Number of Participants Analyzed 35 36
Mean (Standard Deviation)
Unit of Measure: hours
7.05  (2.141) 6.53  (2.354)
Time Frame 3 months and 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketorolac Tromethamine (Given Alone) Fluticasone Propionate + Ketorolac Tromethamine
Hide Arm/Group Description A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6. Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
All-Cause Mortality
Ketorolac Tromethamine (Given Alone) Fluticasone Propionate + Ketorolac Tromethamine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ketorolac Tromethamine (Given Alone) Fluticasone Propionate + Ketorolac Tromethamine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/36 (0.00%)      0/36 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ketorolac Tromethamine (Given Alone) Fluticasone Propionate + Ketorolac Tromethamine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/36 (22.22%)      7/36 (19.44%)    
General disorders     
Fatigue * 1  1/36 (2.78%)  1 2/36 (5.56%)  2
Nervous system disorders     
Headache * 1  4/36 (11.11%)  5 1/36 (2.78%)  1
Somnolence * 1  1/36 (2.78%)  1 4/36 (11.11%)  4
Respiratory, thoracic and mediastinal disorders     
Sneezing * 1  2/36 (5.56%)  2 0/36 (0.00%)  0
*
Indicates events were collected by non-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 ext 828
Responsible Party: David Bregman, M.D., Ph.D., Luitpold Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01365611     History of Changes
Other Study ID Numbers: ROX 2006-04
First Submitted: June 1, 2011
First Posted: June 3, 2011
Results First Submitted: August 9, 2012
Results First Posted: April 30, 2013
Last Update Posted: March 15, 2017