A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00717860
First received: July 16, 2008
Last updated: September 6, 2011
Last verified: September 2011
Results First Received: July 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Fungal Infection
Interventions: Drug: caspofungin acetate
Drug: Comparator: Micafungin sodium

  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
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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
Caspofungin Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
Micafungin Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.

Participant Flow:   Overall Study
    Caspofungin     Micafungin  
STARTED     61     60  
COMPLETED     34     32  
NOT COMPLETED     27     28  
Clinical adverse experience                 5                 9  
Laboratory adverse experience                 2                 2  
Lack of Efficacy                 7                 13  
Discontinued for other reason                 6                 1  
Withdrew consent                 7                 3  



  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
Caspofungin Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
Micafungin Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
Total Total of all reporting groups

Baseline Measures
    Caspofungin     Micafungin     Total  
Number of Participants  
[units: participants]
  61     60     121  
Age  
[units: years]
Mean ± Standard Deviation
  68.9  ± 11.2     69.3  ± 9.0     69.1  ± 10.1  
Gender  
[units: participants]
     
Female     11     14     25  
Male     50     46     96  



  Outcome Measures
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1.  Primary:   Number of Participants With a Significant Drug-related Adverse Experience   [ Time Frame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis ]

2.  Secondary:   Number of Participants With a Specific Safety Finding   [ Time Frame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis ]

3.  Secondary:   Number of Participants With Favorable Overall Response at the End of Study Therapy   [ Time Frame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis ]


  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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00717860     History of Changes
Other Study ID Numbers: MK-0991-062, 2008_013
Study First Received: July 16, 2008
Results First Received: July 28, 2011
Last Updated: September 6, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency