A Study to Assess the Clinical Effects of Navarixin in Participants With Psoriasis (MK-7123-009)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00684593
First received: May 22, 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: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: Navarixin 10 mg
Other: 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
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Reporting Groups
  Description
Navarixin Navarixin 30 mg administered orally once daily for 28 days.
Placebo Matching placebo to Navarixin administered orally once daily for 28 days.

Participant Flow:   Overall Study
    Navarixin     Placebo  
STARTED     21     10  
COMPLETED     21     8  
NOT COMPLETED     0     2  
Adverse Event                 0                 2  



  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.
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Reporting Groups
  Description
Navarixin Navarixin 30 mg administered orally once daily for 28 days.
Placebo Matching placebo to Navarixin administered orally once daily for 28 days.
Total Total of all reporting groups

Baseline Measures
    Navarixin     Placebo     Total  
Number of Participants  
[units: participants]
  21     10     31  
Age  
[units: Years]
Mean ± Standard Deviation
  49.5  ± 10.5     43.9  ± 13.4     47.7  ± 11.6  
Gender  
[units: Participants]
     
Female     2     2     4  
Male     19     8     27  



  Outcome Measures
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1.  Primary:   Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29   [ Time Frame: Baseline and Day 29 ]

2.  Secondary:   Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29   [ Time Frame: Day 29 ]

3.  Secondary:   Mean Maximum Plasma Concentration (Cmax) of Navarixin at Day 28   [ Time Frame: Day 28 ]

4.  Secondary:   Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC [0-24]) of Navarixin at Day 28   [ Time Frame: Day 28 ]

5.  Secondary:   Mean Terminal Phase Half-life (T1/2) of Navarixin at Day 28   [ Time Frame: Day 28 ]

6.  Secondary:   Median Time to Maximum Plasma Concentration (Tmax) of Navarixin at Day 28   [ Time Frame: Day 28 ]


  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: NCT00684593     History of Changes
Other Study ID Numbers: P04481, 2006-006601-83, P04481
Study First Received: May 22, 2008
Results First Received: September 26, 2014
Last Updated: September 26, 2014
Health Authority: Denmark: Danish Medicines Agency