Tolerability, Safety and Pharmacokinetics of Four Formulations of Ketorolac Tromethamine in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01355588
First received: May 16, 2011
Last updated: March 19, 2013
Last verified: March 2013
Results First Received: November 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Healthy Volunteers
Interventions: Drug: Ketorolac Tromethamine
Drug: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl)
Drug: Ketorolac Tromethamine with 5% Lidocaine HCl
Drug: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl

  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
1 month and 2 weeks; Medeval Limited Skelton House, Manchester Science Park, Lloyd Street North, Manchester M15 6SH, U.K.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment A, Treatment C, Treatment D, Treatment B Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
Treatment B, Treatment D, Treatment C, Treatment A Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
Treatment C, Treatment B, Treatment A, Treatment D Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
Treatment D, Treatment A, Treatment B, Treatment C Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN

Participant Flow for 7 periods

Period 1:   First Intervention (Day 1)
    Treatment A, Treatment C, Treatment D, Treatment B     Treatment B, Treatment D, Treatment C, Treatment A     Treatment C, Treatment B, Treatment A, Treatment D     Treatment D, Treatment A, Treatment B, Treatment C  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  

Period 2:   Washout (3-7 Days)
    Treatment A, Treatment C, Treatment D, Treatment B     Treatment B, Treatment D, Treatment C, Treatment A     Treatment C, Treatment B, Treatment A, Treatment D     Treatment D, Treatment A, Treatment B, Treatment C  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  

Period 3:   Second Intervention (After Washout)
    Treatment A, Treatment C, Treatment D, Treatment B     Treatment B, Treatment D, Treatment C, Treatment A     Treatment C, Treatment B, Treatment A, Treatment D     Treatment D, Treatment A, Treatment B, Treatment C  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  

Period 4:   Washout (3-7 Days)
    Treatment A, Treatment C, Treatment D, Treatment B     Treatment B, Treatment D, Treatment C, Treatment A     Treatment C, Treatment B, Treatment A, Treatment D     Treatment D, Treatment A, Treatment B, Treatment C  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  

Period 5:   Third Intervention (After Washout)
    Treatment A, Treatment C, Treatment D, Treatment B     Treatment B, Treatment D, Treatment C, Treatment A     Treatment C, Treatment B, Treatment A, Treatment D     Treatment D, Treatment A, Treatment B, Treatment C  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  

Period 6:   Washout (3-7 Days)
    Treatment A, Treatment C, Treatment D, Treatment B     Treatment B, Treatment D, Treatment C, Treatment A     Treatment C, Treatment B, Treatment A, Treatment D     Treatment D, Treatment A, Treatment B, Treatment C  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  

Period 7:   Fourth Intervention (After Washout)
    Treatment A, Treatment C, Treatment D, Treatment B     Treatment B, Treatment D, Treatment C, Treatment A     Treatment C, Treatment B, Treatment A, Treatment D     Treatment D, Treatment A, Treatment B, Treatment C  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     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
Treatment A, Treatment C, Treatment D, Treatment B Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
Treatment B, Treatment D, Treatment C, Treatment A Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
Treatment C, Treatment B, Treatment A, Treatment D Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
Treatment D, Treatment A, Treatment B, Treatment C Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
Total Total of all reporting groups

Baseline Measures
    Treatment A, Treatment C, Treatment D, Treatment B     Treatment B, Treatment D, Treatment C, Treatment A     Treatment C, Treatment B, Treatment A, Treatment D     Treatment D, Treatment A, Treatment B, Treatment C     Total  
Number of Participants  
[units: participants]
  4     4     4     4     16  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     4     4     4     4     16  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  34.25  ± 17.21     40.75  ± 19.97     34.0  ± 15.90     50.25  ± 10.31     39.8  ± 16.0  
Gender  
[units: participants]
         
Female     2     0     1     2     5  
Male     2     4     3     2     11  
Region of Enrollment  
[units: participants]
         
United Kingdom     4     4     4     4     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose ]

2.  Primary:   Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Post-dose (AUC 0-t)   [ Time Frame: Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose ]

3.  Primary:   Area Under the Plasma Concentration-time Profile From Time Zero to Infinity (AUC 0-∞)   [ Time Frame: Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose ]

4.  Secondary:   Time to Reach Maximum Plasma Concentration (Tmax)   [ Time Frame: Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) 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
No text entered.


  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


Responsible Party: David Bregman, M.D., Ph.D., Luitpold Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01355588     History of Changes
Other Study ID Numbers: ROX 2005-02
Study First Received: May 16, 2011
Results First Received: November 16, 2012
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency