Study to Assess the Absorption and Tolerability of Intranasal Ketorolac Tromethamine and to Assess the Effects of Oxymetazoline Hydrochloride and Fluticasone Propionate on the Absorption and Tolerability of Intranasal Ketorolac Tromethamine in Participants With Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01365650
First received: June 1, 2011
Last updated: June 24, 2015
Last verified: June 2015
Results First Received: August 6, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Allergic Rhinitis
Interventions: Drug: Ketorolac Tromethamine
Drug: Oxymetazoline Hydrochloride
Drug: Fluticasone Propionate

  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
December 18, 2007 through February 15, 2008; Medical Clinic

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
Symptomatic Allergic Rhinitis Treatment A: Single intranasal (i.n.) dose of Ketorolac tromethamine (KT) 30 mg (one 15 mg spray into each nostril) on day 1 of Period 1 followed by a 2-7 day washout interval Treatment B: Single i.n. dose of oxymetazoline hydrochloride (OH) followed 30 minutes later by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) of Period 2 followed by a 2-7 day washout interval Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) on day 1 of Period 3

Participant Flow for 3 periods

Period 1:   Treatment A
    Symptomatic Allergic Rhinitis  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 2:   Treatment B
    Symptomatic Allergic Rhinitis  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 3:   Treatment C
    Symptomatic Allergic Rhinitis  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     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
All Study Participants Treatment A: Single intranasal (i.n.) dose of Ketorolac tromethamine (KT) 30 mg (one 15 mg spray into each nostril) on day 1 of Period 1 followed by a 2-7 day washout interval Treatment B: Single i.n. dose of oxymetazoline hydrochloride (OH) followed 30 minutes later by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) of Period 2 followed by a 2-7 day washout interval Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) on day 1 of Period 3

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  24  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     22  
>=65 years     2  
Age  
[units: years]
Mean (Standard Deviation)
  42.6  (16.3)  
Gender  
[units: participants]
 
Female     9  
Male     15  
Region of Enrollment  
[units: participants]
 
Australia     24  



  Outcome Measures
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1.  Primary:   Cmax (the Maximum Observed Plasma Concentration)   [ Time Frame: Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine ]

2.  Primary:   Tmax (the Time to Maximum Concentration)   [ Time Frame: Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine ]

3.  Primary:   AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose)   [ Time Frame: Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine ]

4.  Primary:   AUC 0-∞ (the AUC From Time Zero to Infinity, Where Possible)   [ Time Frame: Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine ]

5.  Primary:   t1/2z (the Terminal Half-life, Where Possible)   [ Time Frame: Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine ]

6.  Primary:   MRT (the Mean Residence Time)   [ Time Frame: Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine ]


  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



Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01365650     History of Changes
Other Study ID Numbers: ROX 2007-03
Study First Received: June 1, 2011
Results First Received: August 6, 2012
Last Updated: June 24, 2015
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration