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

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ClinicalTrials.gov Identifier: NCT00468728
Recruitment Status : Completed
First Posted : May 3, 2007
Results First Posted : July 29, 2011
Last Update Posted : April 21, 2017
Information provided by (Responsible Party):
Optimer Pharmaceuticals LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Clostridium Infections
Interventions: Drug: PAR-101/OPT-80
Drug: Vancomycin

  Participant Flow

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
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] 
[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 
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 256   253   509 
[Units: Years]
Mean (Standard Deviation)
 62.7  (18.3)   64.1  (18.0)   63.4  (18.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      161  62.9%      149  58.9%      310  60.9% 
Male      95  37.1%      104  41.1%      199  39.1% 
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

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

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

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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Optimer Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00468728     History of Changes
Obsolete Identifiers: NCT00427869
Other Study ID Numbers: 5119-019
101.1.C.004 ( Other Identifier: Optimerpharma Study Number )
First Submitted: May 1, 2007
First Posted: May 3, 2007
Results First Submitted: July 1, 2011
Results First Posted: July 29, 2011
Last Update Posted: April 21, 2017