Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study (TARGET3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01543178
First received: February 27, 2012
Last updated: June 15, 2015
Last verified: June 2015
Results First Received: June 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Irritable Bowel Syndrome With Diarrhea
Interventions: Drug: open-label rifaximin
Drug: double-blind placebo
Drug: double-blind 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
The screening phase included a 10 (±3) day run-in treatment period, during which subjects received single-blind placebo and completed a daily IBS symptom diary. Subjects who had active symptoms of IBS with diarrhea, and satisfied other entry criteria, entered the open-label period of study.

Reporting Groups
  Description
Open-label Rifaximin

Subjects received open-label rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. Responders continued into Maintenance Phase 1 (treatment free). Nonresponders withdrew from the study.

Of the 2583 subjects in this group, 636 eventually met criteria for recurrence in Maintenance Phase 1, entered the double-blind period, and were randomized 1:1 to receive rifaximin 550 mg or placebo.

Double-blind Rifaximin (Retreatment) The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period. For participant flow during the open-label period, these subjects are included in the 2583 subjects in the open-label rifaximin group.
Double-blind Placebo (Retreatment) The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period. For participant flow during the open-label period, these subjects are included in the 2583 subjects in the open-label rifaximin group.

Participant Flow for 2 periods

Period 1:   Open-label Period
    Open-label Rifaximin     Double-blind Rifaximin (Retreatment)     Double-blind Placebo (Retreatment)  
STARTED     2583 [1]   0 [2]   0 [3]
COMPLETED     636     0     0  
NOT COMPLETED     1947     0     0  
[1] 2583 subjects entered the open-label period, but 4 received no rifaximin; 2579 received rifaximin.
[2] The double-blind rifaximin arm/group is not applicable to the open-label period.
[3] The double-blind placebo arm/group is not applicable to the open-label period.

Period 2:   Double-blind Period
    Open-label Rifaximin     Double-blind Rifaximin (Retreatment)     Double-blind Placebo (Retreatment)  
STARTED     0 [1]   328 [2]   308 [3]
COMPLETED     0     284 [4]   271 [5]
NOT COMPLETED     0     44     37  
[1] The open-label rifaximin arm/group is not applicable to the double-blind period.
[2] 636 subjects had recurrence in open-label period; 328 randomized to rifaximin.
[3] 636 subjects had recurrence in open-label period; 308 randomized to placebo.
[4] 295 completed 1st double-blind retreatment and 284 completed 2nd double-blind retreatment.
[5] 283 completed 1st double-blind retreatment and 271 completed 2nd double-blind retreatment.



  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.
Baseline results were summarized for the safety population, defined as patients who received at least 1 dose of study drug. Results are presented for patients in the open-label period only (1943) and for patients who eventually were randomized to rifaximin (329) or placebo (308) (ie, participated in both open-label and double-blind periods).

Reporting Groups
  Description
Open-label Rifaximin Only The 1943 subjects in this group did not continue into the double-blind period of the study. Open-label treatment was rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up.
Double-blind Rifaximin (Retreatment) The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.
Double-blind Placebo (Retreatment) The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.
Total Total of all reporting groups

Baseline Measures
    Open-label Rifaximin Only     Double-blind Rifaximin (Retreatment)     Double-blind Placebo (Retreatment)     Total  
Number of Participants  
[units: participants]
  1943     328     308     2579  
Age  
[units: participants]
       
<=18 years     8     0     1     9  
Between 18 and 65 years     1763     289     278     2330  
>=65 years     172     39     29     240  
Age  
[units: years]
Mean (Standard Deviation)
  46.3  (13.5)     47.9  (14.2)     45.6  (13.8)     46.4  (13.7)  
Gender  
[units: participants]
       
Female     1319     222     219     1760  
Male     624     106     89     819  



  Outcome Measures

1.  Primary:   Repeat Treatment Responders   [ Time Frame: 4-week treatment-free follow-up in double-blind repeat treatment phase. ]


  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
No text entered.


  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 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


No publications provided


Responsible Party: Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01543178     History of Changes
Other Study ID Numbers: RFIB3053
Study First Received: February 27, 2012
Results First Received: June 15, 2015
Last Updated: June 15, 2015
Health Authority: United States: Food and Drug Administration