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Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS) (TARGET 1)

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ClinicalTrials.gov Identifier: NCT00731679
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Non-Constipation Irritable Bowel Syndrome
Interventions: Drug: Rifaximin
Drug: Placebo

  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
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Reporting Groups
  Description
Placebo Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Rifaximin Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.

Participant Flow:   Overall Study
    Placebo   Rifaximin
STARTED   314   309 
COMPLETED   292   283 
NOT COMPLETED   22   26 
Adverse Event                7                8 
Withdrawal by Subject                8                8 
Lost to Follow-up                7                8 
Noncompliance                0                1 
Pregnancy                0                1 



  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.
The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug.

Reporting Groups
  Description
Placebo Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Rifaximin Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Total Total of all reporting groups

Baseline Measures
   Placebo   Rifaximin   Total 
Overall Participants Analyzed 
[Units: Participants]
 314   309   623 
Age 
[Units: Participants]
     
<=18 years   1   1   2 
Between 18 and 65 years   275   274   549 
>=65 years   38   34   72 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.5  (14.6)   46.2  (15.0)   45.8  (14.8) 
Gender 
[Units: Participants]
     
Female   222   235   457 
Male   92   74   166 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   2   2 
Asian   1   2   3 
Native Hawaiian or Other Pacific Islander   1   0   1 
Black or African American   30   24   54 
White   280   281   561 
More than one race   2   0   2 
Unknown or Not Reported   0   0   0 


  Outcome Measures

1.  Primary:   Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).   [ Time Frame: 4 weeks ]

2.  Secondary:   Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).   [ Time Frame: 4 weeks ]


  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
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  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 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: David Sorscher
Organization: Salix
phone: 919-862-1827
e-mail: david.sorscher@salix.com


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

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00731679     History of Changes
Other Study ID Numbers: RFIB3007
First Submitted: July 16, 2008
First Posted: August 11, 2008
Results First Submitted: June 30, 2014
Results First Posted: July 28, 2014
Last Update Posted: July 28, 2014