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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01365624
First received: June 1, 2011
Last updated: January 3, 2013
Last verified: January 2013
Results First Received: August 2, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy Subjects
Intervention: Drug: Ketorolac tromethamine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
February 2008 through April 2008; Clinical Unit

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After subjects had given their informed consent, subjects were required to pass a screening visit within 3 weeks prior to study drug administration.

Reporting Groups
  Description
Ketorolac Tromethamine (Elderly Adults ≥ 65) Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Ketorolac Tromethamine (Nonelderly Adults < 65) Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)

Participant Flow:   Overall Study
    Ketorolac Tromethamine (Elderly Adults ≥ 65)     Ketorolac Tromethamine (Nonelderly Adults < 65)  
STARTED     15     15  
COMPLETED     15     15  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ketorolac Tromethamine (Elderly Adults ≥ 65) Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Ketorolac Tromethamine (Nonelderly Adults < 65) Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Total Total of all reporting groups

Baseline Measures
    Ketorolac Tromethamine (Elderly Adults ≥ 65)     Ketorolac Tromethamine (Nonelderly Adults < 65)     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     15     15  
>=65 years     15     0     15  
Age  
[units: years]
Mean ± Standard Deviation
  71.9  ± 5.9     44.2  ± 10.3     58.1  ± 16.3  
Gender  
[units: participants]
     
Female     8     6     14  
Male     7     9     16  
Region of Enrollment  
[units: participants]
     
United States     15     15     30  



  Outcome Measures
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1.  Primary:   Cmax (Maximum Plasma Concentration)   [ 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 ]

2.  Primary:   Tmax (Time to Reach Maximum Plasma Concentration)   [ 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 ]

3.  Primary:   AUClast (Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Time Point Post-dose   [ 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 ]

4.  Primary:   AUC (Area Under the Plasma Concentration-time Profile From Time 0 to Infinity   [ 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 ]

5.  Primary:   t1/2z (Terminal Half-life)   [ 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 ]

6.  Primary:   MRT (Mean Residence Time)   [ 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: dbregman@lpicrd.com


No publications provided by Luitpold Pharmaceuticals

Publications automatically indexed to this study:

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01365624     History of Changes
Other Study ID Numbers: ROX 2007-02
Study First Received: June 1, 2011
Results First Received: August 2, 2012
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration