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Efficacy and Safety of Navarixin (SCH 527123) in Participants With Allergen-Induced Asthma (P05363)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00688467
First received: May 29, 2008
Last updated: September 26, 2014
Last verified: September 2014
Results First Received: September 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Navarixin
Drug: Placebo

  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
No text entered.

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
Navarixin → Placebo Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2
Placebo → Navarixin Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2

Participant Flow for 2 periods

Period 1:   Treatment Period 1
    Navarixin → Placebo     Placebo → Navarixin  
STARTED     9     10  
COMPLETED     7     8  
NOT COMPLETED     2     2  
Adverse Event                 2                 1  
Did not meet protocol eligibility                 0                 1  

Period 2:   Treatment Period 2
    Navarixin → Placebo     Placebo → Navarixin  
STARTED     7     8  
COMPLETED     7     6  
NOT COMPLETED     0     2  
Protocol Violation                 0                 1  
Adverse Event                 0                 1  



  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
Navarixin → Placebo Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2
Placebo → Navarixin Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2
Total Total of all reporting groups

Baseline Measures
    Navarixin → Placebo     Placebo → Navarixin     Total  
Number of Participants  
[units: participants]
  9     10     19  
Age  
[units: Years]
Mean ± Standard Deviation
  34.3  ± 12.0     24.9  ± 4.0     29.4  ± 9.8  
Gender  
[units: Participants]
     
Female     6     7     13  
Male     3     3     6  



  Outcome Measures
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1.  Primary:   Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 3 to 7 Hours (AUC3-7hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin   [ Time Frame: Baseline and between 3 and 7 hours after allergen challenge ]

2.  Secondary:   Maximum Change From Baseline in FEV1 During the LAR Following 9 Days of Pretreatment With Navarixin   [ Time Frame: Baseline and between 3 and 7 hours after allergen challenge ]

3.  Secondary:   Change in Concentration of Methacholine That Initiated a 20% Reduction in FEV1 From 24 Hours Before (Baseline) to 24 Hours After Allergen Challenge   [ Time Frame: Baseline and 24 hours after allergen challenge ]

4.  Secondary:   Percent Change From Baseline in FEV1 Area Under the Curve From 0 to 2 Hours (AUC0-2hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin   [ Time Frame: Baseline and between 0 to 2 hours after allergen challenge ]

5.  Secondary:   Maximum Percent Change From Baseline in FEV1 During the Early Asthmatic Response Following 9 Days of Pretreatment With Navarixin   [ Time Frame: Baseline and between 0 to 2 hours after allergen challenge ]

6.  Secondary:   Change From Baseline in Sputum Neutrophils After Allergen Challenge Following 9 Days Pretreatment With Navarixin   [ Time Frame: Baseline and 7 and 24 hours after allergen challenge ]

7.  Secondary:   Change From Baseline in Peripheral Blood Eosinophil Count After Allergen Challenge Following 9 Days Pretreatment With Navarixin   [ Time Frame: Baseline and 7 and 24 hours after allergen challenge ]

8.  Secondary:   Change From Baseline in Sputum Interleukin 8 (IL-8) After Allergen Challenge Following 9 Days Pretreatment With Navarixin   [ Time Frame: Baseline and 7 and 24 hours after allergen challenge ]

9.  Secondary:   Change From Baseline in Sputum Neutrophil Elastase After Allergen Challenge Following 9 Days Pretreatment With Navarixin   [ Time Frame: Baseline and 7 and 24 hours after allergen challenge ]

10.  Secondary:   Change From Baseline in Sputum Myeloperoxidase (MPO) Level After Allergen Challenge Following 9 Days Pretreatment With Navarixin   [ Time Frame: Baseline and 7 and 24 hours after allergen challenge ]

11.  Secondary:   Change From Baseline in Sputum Eosinophil Cationic Protein (ECP) Level After Allergen Challenge Following 9 Days Pretreatment With Navarixin   [ Time Frame: Baseline and 7 and 24 hours after allergen challenge ]

12.  Secondary:   Number of Participants With an Adverse Event (AE)   [ Time Frame: Up to 48 days ]

13.  Secondary:   Number of Participants Discontinued From the Study Because of an Adverse Event   [ Time Frame: Up to 48 days ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00688467     History of Changes
Other Study ID Numbers: P05363, MK-7123-016
Study First Received: May 29, 2008
Results First Received: September 26, 2014
Last Updated: September 26, 2014
Health Authority: Canada: Health Canada