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Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01365624
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : February 6, 2013
Last Update Posted : February 6, 2013
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy Subjects
Intervention Drug: Ketorolac tromethamine
Enrollment 30
Recruitment Details February 2008 through April 2008; 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 (Elderly Adults ≥ 65) Ketorolac Tromethamine (Nonelderly Adults < 65)
Hide Arm/Group Description Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril) Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Period Title: Overall Study
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Ketorolac Tromethamine (Elderly Adults ≥ 65) Ketorolac Tromethamine (Nonelderly Adults < 65) Total
Hide Arm/Group Description Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril) Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril) Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
15
 100.0%
15
  50.0%
>=65 years
15
 100.0%
0
   0.0%
15
  50.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
71.9  (5.9) 44.2  (10.3) 58.1  (16.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
8
  53.3%
6
  40.0%
14
  46.7%
Male
7
  46.7%
9
  60.0%
16
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Cmax (Maximum Plasma Concentration)
Hide Description [Not Specified]
Time Frame Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Tromethamine (Elderly Adults ≥ 65) Ketorolac Tromethamine (Nonelderly Adults < 65)
Hide Arm/Group Description:
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
1782.286  (1184.843) 1840.111  (995.930)
2.Primary Outcome
Title Tmax (Time to Reach Maximum Plasma Concentration)
Hide Description [Not Specified]
Time Frame Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Tromethamine (Elderly Adults ≥ 65) Ketorolac Tromethamine (Nonelderly Adults < 65)
Hide Arm/Group Description:
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Overall Number of Participants Analyzed 15 15
Median (Full Range)
Unit of Measure: hours
0.750
(0.50 to 1.00)
0.750
(0.25 to 1.00)
3.Primary Outcome
Title AUClast (Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Time Point Post-dose
Hide Description [Not Specified]
Time Frame Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Tromethamine (Elderly Adults ≥ 65) Ketorolac Tromethamine (Nonelderly Adults < 65)
Hide Arm/Group Description:
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: ng*hours/mL
7323.5  (4633.1) 6536.5  (3361.8)
4.Primary Outcome
Title AUC (Area Under the Plasma Concentration-time Profile From Time 0 to Infinity
Hide Description [Not Specified]
Time Frame Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.
Arm/Group Title Ketorolac Tromethamine (Elderly Adults ≥ 65) Ketorolac Tromethamine (Nonelderly Adults < 65)
Hide Arm/Group Description:
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: ng*hours/mL
8794.8  (4129.4) 6890.8  (3448.5)
5.Primary Outcome
Title t1/2z (Terminal Half-life)
Hide Description [Not Specified]
Time Frame Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.
Arm/Group Title Ketorolac Tromethamine (Elderly Adults ≥ 65) Ketorolac Tromethamine (Nonelderly Adults < 65)
Hide Arm/Group Description:
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: hours
4.521  (1.142) 3.313  (0.961)
6.Primary Outcome
Title MRT (Mean Residence Time)
Hide Description [Not Specified]
Time Frame Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.
Arm/Group Title Ketorolac Tromethamine (Elderly Adults ≥ 65) Ketorolac Tromethamine (Nonelderly Adults < 65)
Hide Arm/Group Description:
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: hours
6.024  (1.496) 4.441  (1.060)
Time Frame 1 month and 1 week
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketorolac Tromethamine (Elderly Adults ≥ 65) Ketorolac Tromethamine (Nonelderly Adults < 65)
Hide Arm/Group Description Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril) Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
All-Cause Mortality
Ketorolac Tromethamine (Elderly Adults ≥ 65) Ketorolac Tromethamine (Nonelderly Adults < 65)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ketorolac Tromethamine (Elderly Adults ≥ 65) Ketorolac Tromethamine (Nonelderly Adults < 65)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      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 (Elderly Adults ≥ 65) Ketorolac Tromethamine (Nonelderly Adults < 65)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      1/15 (6.67%)    
Infections and infestations     
Hordeolum * 1  1/15 (6.67%)  1 0/15 (0.00%)  0
Nervous system disorders     
Headache * 1  0/15 (0.00%)  0 1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01365624     History of Changes
Other Study ID Numbers: ROX 2007-02
First Submitted: June 1, 2011
First Posted: June 3, 2011
Results First Submitted: August 2, 2012
Results First Posted: February 6, 2013
Last Update Posted: February 6, 2013