A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267) (STOP CHAGAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01377480
First received: May 13, 2011
Last updated: July 13, 2015
Last verified: July 2015
Results First Received: July 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chagas Disease
Interventions: Drug: Posaconazole
Drug: Placebo for posaconazole
Drug: Benznidazole

  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
A total of 393 participants were screened, 123 were eligible for enrollment, and 120 were randomized

Reporting Groups
  Description
Posaconazole POS 400 mg (10 mL) oral suspension twice daily for 60 days
Placebo POS placebo (10 mL) oral suspension twice daily for 60 days
Posaconazole + Benznidazole POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
Benznidazole + Placebo BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days

Participant Flow:   Overall Study
    Posaconazole     Placebo     Posaconazole + Benznidazole     Benznidazole + Placebo  
STARTED     32 [1]   30     28 [2]   30  
COMPLETED     32     29     18     19  
NOT COMPLETED     0     1     10     11  
Protocol Violation                 0                 0                 0                 4  
Evidence of drug-induced hepatotoxicity                 0                 1                 1                 0  
Withdrawal by Subject                 0                 0                 1                 0  
Serious adverse event                 0                 0                 1                 1  
Not specified                 0                 0                 7                 6  
[1] Includes 2 participants randomized to POS + BNZ but who only received POS
[2] 2 participants received only POS and were analyzed as part of the posaconazole group



  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
Posaconazole POS 400 mg (10 mL) oral suspension twice daily for 60 days
Placebo POS placebo (10 mL) oral suspension twice daily for 60 days
Posaconazole + Benznidazole POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
Benznidazole + Placebo BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
Total Total of all reporting groups

Baseline Measures
    Posaconazole     Placebo     Posaconazole + Benznidazole     Benznidazole + Placebo     Total  
Number of Participants  
[units: participants]
  32     30     28     30     120  
Age  
[units: years]
Mean (Standard Deviation)
  40.3  (8.6)     42.2  (7.8)     40.2  (8.4)     40.4  (7.7)     40.8  (8.1)  
Gender  
[units: Participants]
         
Female     16     7     13     17     53  
Male     16     23     15     13     67  



  Outcome Measures

1.  Primary:   Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction   [ Time Frame: Day 180 ]


  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: NCT01377480     History of Changes
Other Study ID Numbers: P05267, MK-5592-055
Study First Received: May 13, 2011
Results First Received: July 13, 2015
Last Updated: July 13, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica