PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

This study has been completed.
Sponsor:
Information provided by:
Optimer Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00468728
First received: May 1, 2007
Last updated: August 8, 2011
Last verified: August 2011
Results First Received: July 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Clostridium Infections
Diarrhea
Interventions: Drug: PAR-101/OPT-80
Drug: Vancomycin

  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
Subjects were enrolled from April 2007 to November 2009 by centers in the United States, Canada, France, Spain, Belgium, Germany, United Kingdom, Italy, and Sweden.

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
Vancomycin 125 mg administered 4 times daily (q6hr)
PAR-101/OPT-80 200 mg administered twice daily (q12hr)

Participant Flow for 3 periods

Period 1:   Enrollment
    Vancomycin     PAR-101/OPT-80  
STARTED     264     271  
COMPLETED     260 [1]   264 [1]
NOT COMPLETED     4     7  
[1] 1 fidaxomicin subject received vancomycin, 11 subjects didn't take drug

Period 2:   Treatment
    Vancomycin     PAR-101/OPT-80  
STARTED     260     264  
COMPLETED     256     253  
NOT COMPLETED     4     11  
criteria for mITT population                 4                 11  

Period 3:   Follow-up
    Vancomycin     PAR-101/OPT-80  
STARTED     256     253  
COMPLETED     222     222  
NOT COMPLETED     34     31  
mITT failure                 34                 31  



  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
Vancomycin 125 mg administered 4 times daily (q6hr)
PAR-101/OPT-80 200 mg administered twice daily (q12hr)
Total Total of all reporting groups

Baseline Measures
    Vancomycin     PAR-101/OPT-80     Total  
Number of Participants  
[units: participants]
  256     253     509  
Age  
[units: years]
Mean ± Standard Deviation
  62.7  ± 18.3     64.1  ± 18.0     63.4  ± 18.1  
Gender  
[units: participants]
     
Female     161     149     310  
Male     95     104     199  
Region of Enrollment  
[units: participants]
     
France     8     11     19  
United States     76     74     150  
Canada     82     79     161  
Spain     4     5     9  
Belgium     20     22     42  
Germany     19     18     37  
United Kingdom     27     26     53  
Italy     13     14     27  
Sweden     7     4     11  



  Outcome Measures
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1.  Primary:   Cure Rate at End of Therapy   [ Time Frame: Study day 10 (+/- 2 days) ]

2.  Secondary:   Recurrence   [ Time Frame: Study days 11-40 ]

3.  Secondary:   Global Cure   [ Time Frame: End of Study ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Scientific Officer
Organization: Optimer Pharmaceuticals, Inc.
phone: 1-855-343-4243
e-mail: medinfo@optimerpharma.com


No publications provided by Optimer Pharmaceuticals

Publications automatically indexed to this study:

Responsible Party: Y.K. Shue, Optimer Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00468728     History of Changes
Obsolete Identifiers: NCT00427869
Other Study ID Numbers: 101.1.C.004, 101.1.C.004
Study First Received: May 1, 2007
Results First Received: July 1, 2011
Last Updated: August 8, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ministry of Health and Consumption
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: The Italian Medicines Agency
Sweden: Medical Products Agency
Germany: BfArM