POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00423267
First received: January 17, 2007
Last updated: April 28, 2014
Last verified: April 2014
Results First Received: May 27, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Coccidioidomycosis
Interventions: Drug: Posaconazole
Drug: Fluconazole

  Participant Flow
  Hide Participant Flow

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
Posaconazole Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months. One subject from period A declined to participate in the amended protocol and discontinued study treatment after 12 months of study drug administration.
Fluconazole Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.

Participant Flow for 2 periods

Period 1:   Period A
    Posaconazole     Fluconazole  
STARTED     9     7  
COMPLETED     7     6  
NOT COMPLETED     2     1  
Withdrawal by Subject                 0                 1  
Non-compliance with protocol                 1                 0  
Administrative                 1                 0  

Period 2:   Period B
    Posaconazole     Fluconazole  
STARTED     12     0  
COMPLETED     12     0  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Posaconazole Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
Fluconazole Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
Total Total of all reporting groups

Baseline Measures
    Posaconazole     Fluconazole     Total  
Number of Participants  
[units: participants]
  9     7     16  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     7     14  
>=65 years     2     0     2  
Gender  
[units: participants]
     
Female     4     2     6  
Male     5     5     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A   [ Time Frame: 12 months ]

2.  Primary:   Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) in Period B   [ Time Frame: 12 months ]

3.  Secondary:   Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A   [ Time Frame: 12 months ]

4.  Secondary:   Number of Participants With Treatment-emergent Adverse Events (TEAEs) That Occurred With POS in Period B   [ Time Frame: 12 months ]

5.  Secondary:   Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A   [ Time Frame: 12 months ]

6.  Secondary:   Number of Participants With Laboratory Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS in Period B   [ Time Frame: 12 months ]

7.  Secondary:   Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period A   [ Time Frame: 12 months ]

8.  Secondary:   Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period B   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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: NCT00423267     History of Changes
Other Study ID Numbers: P04558
Study First Received: January 17, 2007
Results First Received: May 27, 2010
Last Updated: April 28, 2014
Health Authority: United States: Food and Drug Administration