Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Determine the Tolerability, Safety and Pharmacokinetics of Ketorolac Tromethamine by Intranasal Administration in Healthy Volunteers

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: NCT01363050
Recruitment Status : Completed
First Posted : June 1, 2011
Results First Posted : May 3, 2013
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):
Egalet Ltd

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy Volunteers
Intervention Drug: Ketorolac tromethamine
Enrollment 15
Recruitment Details January 9, 2006 - February 27, 2006; Clinical Unit
Pre-assignment Details After subjects had given their informed consent, subjects were required to pass a screening visit within 3 weeks prior to study drug administration.
Arm/Group Title Ketorolac Tromethamine
Hide Arm/Group Description Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Ketorolac Tromethamine
Hide Arm/Group Description Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
31.7  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
5
  33.3%
Male
10
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 15 participants
15
1.Primary Outcome
Title Cmax (the Maximum Observed Plasma Concentration)
Hide Description PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.
Time Frame Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.
Arm/Group Title Ketorolac Tromethamine
Hide Arm/Group Description:
Ketorolac tromethamine (Day 1) : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
1147.9  (186.0)
2.Primary Outcome
Title Tmax (the Time to Maximum Concentration)
Hide Description PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.
Time Frame Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.
Arm/Group Title Ketorolac Tromethamine
Hide Arm/Group Description:
Ketorolac tromethamine (Day 1) : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: hours
1.000
(1.00 to 7.92)
3.Primary Outcome
Title AUC 0-8h (the Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose)
Hide Description PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.
Time Frame Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.
Arm/Group Title Ketorolac Tromethamine
Hide Arm/Group Description:
Ketorolac tromethamine (Day 1): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: ng*hours/mL
4713.8  (744.8)
4.Primary Outcome
Title Cmax,ss (the Maximum Observed Plasma Concentration at Steady State)
Hide Description PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.
Time Frame Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.
Arm/Group Title Ketorolac Tromethamine
Hide Arm/Group Description:
Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
1382.6  (224.3)
5.Primary Outcome
Title Tmax,ss (the Time to Maximum Concentration at Steady State)
Hide Description PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.
Time Frame Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.
Arm/Group Title Ketorolac Tromethamine
Hide Arm/Group Description:
Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: hours
1.000
(1.00 to 3.00)
6.Primary Outcome
Title Cmin,ss (the Minimum Observed Plasma Concentration at Steady State)
Hide Description PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.
Time Frame Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.
Arm/Group Title Ketorolac Tromethamine
Hide Arm/Group Description:
Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
367.7  (67.7)
7.Primary Outcome
Title Tmin,ss (the Time to Minimum Concentration at Steady State)
Hide Description PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.
Time Frame Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.
Arm/Group Title Ketorolac Tromethamine
Hide Arm/Group Description:
Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: hours
0.000
(0.00 to 8.00)
8.Primary Outcome
Title AUCτ (the Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Steady-state)
Hide Description PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.
Time Frame Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.
Arm/Group Title Ketorolac Tromethamine
Hide Arm/Group Description:
Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: ng*hours/mL
6379.2  (1031.0)
9.Primary Outcome
Title MRT (the Mean Residence Time
Hide Description PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.
Time Frame Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.
Arm/Group Title Ketorolac Tromethamine
Hide Arm/Group Description:
Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: hours
3.368  (0.056)
Time Frame 1 month and 3 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketorolac Tromethamine
Hide Arm/Group Description Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
All-Cause Mortality
Ketorolac Tromethamine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ketorolac Tromethamine
Affected / at Risk (%) # Events
Total   0/15 (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
Affected / at Risk (%) # Events
Total   14/15 (93.33%)    
Eye disorders   
Lacrimation increased * 1  2/15 (13.33%)  4
Gastrointestinal disorders   
Lip dry * 1  1/15 (6.67%)  1
Nausea * 1  1/15 (6.67%)  1
General disorders   
Catheter site haematoma * 1  1/15 (6.67%)  1
Feeling cold * 1  1/15 (6.67%)  1
Infections and infestations   
Rhinitis * 1  1/15 (6.67%)  2
Musculoskeletal and connective tissue disorders   
Myalgia * 1  1/15 (6.67%)  1
Nervous system disorders   
Dizziness * 1  1/15 (6.67%)  1
Headache * 1  3/15 (20.00%)  4
Paraesthesia * 1  1/15 (6.67%)  1
Psychiatric disorders   
Anxiety * 1  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
Nasal discomfort * 1  4/15 (26.67%)  10
Rhinorrhoea * 1  1/15 (6.67%)  1
Sneezing * 1  2/15 (13.33%)  2
Throat irritation * 1  2/15 (13.33%)  3
Vascular disorders   
Orthostatic hypotension * 1  1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.1
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: Egalet Ltd
ClinicalTrials.gov Identifier: NCT01363050     History of Changes
Other Study ID Numbers: ROX 2005-03
First Submitted: May 27, 2011
First Posted: June 1, 2011
Results First Submitted: August 29, 2012
Results First Posted: May 3, 2013
Last Update Posted: March 16, 2017