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A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans

This study has been completed.
Sponsor:
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Alan C. Moss, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01542541
First received: February 27, 2012
Last updated: December 18, 2015
Last verified: December 2015
Results First Received: December 18, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Intestinal FDG Uptake
Intervention: Drug: Rifaximin

  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
No text entered.

Reporting Groups
  Description
Rifaximin Rifaximin: 550mg BID for 2 days
Control Randomly-selected matched PET-CT scans performed on same day as intervention group.

Participant Flow:   Overall Study
    Rifaximin     Control  
STARTED     38     30  
COMPLETED     30     30  
NOT COMPLETED     8     0  



  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
Rifaximin Rifaximin: 550mg BID for 2 days
Control Randomly-selected matched PET-CT scans performed on same day as intervention group.
Total Total of all reporting groups

Baseline Measures
    Rifaximin     Control     Total  
Number of Participants  
[units: participants]
  38     30     68  
Age  
[units: years]
Mean (Standard Deviation)
  56  (19)     56  (19)     56  (19)  
Gender  
[units: participants]
     
Female     17     15     32  
Male     21     15     36  
Region of Enrollment  
[units: participants]
     
United States     38     30     68  



  Outcome Measures

1.  Primary:   SUVmax of FDG in Each Colonic Segment   [ Time Frame: Day 2 ]

2.  Secondary:   SUVavg in Each Colonic Segment   [ Time Frame: Day 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Dr Alan Moss
Organization: BIDMC
phone: 6176673197
e-mail: amoss@bidmc.harvard.edu



Responsible Party: Alan C. Moss, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01542541     History of Changes
Other Study ID Numbers: 2010-P-000101
Study First Received: February 27, 2012
Results First Received: December 18, 2015
Last Updated: December 18, 2015
Health Authority: United States: Food and Drug Administration