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Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS) (TARGET 2)

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ClinicalTrials.gov Identifier: NCT00724126
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : July 28, 2014
Last Update Posted : November 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, 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
Enrollment 637
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Rifaximin
Hide Arm/Group Description Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period. Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Period Title: Overall Study
Started 321 316
Completed 302 301
Not Completed 19 15
Reason Not Completed
Adverse Event             2             0
Withdrawal by Subject             8             6
Lost to Follow-up             6             6
Noncompliance             2             1
Subject randomized although ineligible             1             1
Subject had to leave vicinity of site             0             1
Arm/Group Title Placebo Rifaximin Total
Hide Arm/Group Description Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period. 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 of all reporting groups
Overall Number of Baseline Participants 320 315 635
Hide Baseline Analysis Population Description
The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 315 participants 635 participants
<=18 years
1
   0.3%
0
   0.0%
1
   0.2%
Between 18 and 65 years
282
  88.1%
285
  90.5%
567
  89.3%
>=65 years
37
  11.6%
30
   9.5%
67
  10.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 320 participants 315 participants 635 participants
46.3  (14.6) 45.9  (13.9) 46.1  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 315 participants 635 participants
Female
225
  70.3%
227
  72.1%
452
  71.2%
Male
95
  29.7%
88
  27.9%
183
  28.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 315 participants 635 participants
American Indian or Alaska Native
2
   0.6%
1
   0.3%
3
   0.5%
Asian
2
   0.6%
6
   1.9%
8
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
3
   1.0%
3
   0.5%
Black or African American
14
   4.4%
21
   6.7%
35
   5.5%
White
302
  94.4%
282
  89.5%
584
  92.0%
More than one race
0
   0.0%
2
   0.6%
2
   0.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 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).
Hide Description

The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.

Adequate relief of global IBS symptoms was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.
Arm/Group Title Placebo Rifaximin
Hide Arm/Group Description:
Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Overall Number of Participants Analyzed 320 315
Measure Type: Number
Unit of Measure: percentage of responders
32.2 40.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rifaximin
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.
2.Secondary Outcome
Title 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)
Hide Description

The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.

Adequate relief of bloating was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.
Arm/Group Title Placebo Rifaximin
Hide Arm/Group Description:
Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Overall Number of Participants Analyzed 320 315
Measure Type: Number
Unit of Measure: percentage of responders
31.9 41.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rifaximin
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Logistic
Comments The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.
Time Frame 12 weeks. Adverse events were collected during the 2-week treatment period and during the 10-week follow-up period.
Adverse Event Reporting Description Non-systematic (patient reports) and systematic methods (investigator examinations/laboratory tests) were used to collect adverse events. A subject reporting more than one adverse event for a particular MedDRA preferred term or system organ class was counted only once for that MedDRA preferred term or system organ class.
 
Arm/Group Title Placebo Rifaximin
Hide Arm/Group Description Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period. Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
All-Cause Mortality
Placebo Rifaximin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Rifaximin
Affected / at Risk (%) Affected / at Risk (%)
Total   7/320 (2.19%)   7/315 (2.22%) 
Cardiac disorders     
Atrial fibrillation  1  0/320 (0.00%)  1/315 (0.32%) 
Gastrointestinal disorders     
Abdominal pain  1  1/320 (0.31%)  0/315 (0.00%) 
General disorders     
Chest pain  1  2/320 (0.63%)  1/315 (0.32%) 
Non-cardiac chest pain  1  0/320 (0.00%)  1/315 (0.32%) 
Infections and infestations     
Appendicitis  1  1/320 (0.31%)  0/315 (0.00%) 
Meningitis  1  0/320 (0.00%)  1/315 (0.32%) 
Metabolism and nutrition disorders     
Metabolic acidosis  1  1/320 (0.31%)  0/315 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc displacement  1  0/320 (0.00%)  1/315 (0.32%) 
Neck pain  1  1/320 (0.31%)  0/315 (0.00%) 
Pain in extremity  1  1/320 (0.31%)  0/315 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  1/320 (0.31%)  1/315 (0.32%) 
Nervous system disorders     
Hypoaesthesia  1  0/320 (0.00%)  1/315 (0.32%) 
Psychiatric disorders     
Bipolar I disorder  1  1/320 (0.31%)  0/315 (0.00%) 
Mental status changes  1  1/320 (0.31%)  0/315 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/320 (0.31%)  0/315 (0.00%) 
Vascular disorders     
Hypertension  1  0/320 (0.00%)  1/315 (0.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Rifaximin
Affected / at Risk (%) Affected / at Risk (%)
Total   94/320 (29.38%)   86/315 (27.30%) 
Gastrointestinal disorders     
Abdominal pain  1  11/320 (3.44%)  10/315 (3.17%) 
Constipation  1  8/320 (2.50%)  1/315 (0.32%) 
Diarrhoea  1  7/320 (2.19%)  13/315 (4.13%) 
Nausea  1  11/320 (3.44%)  5/315 (1.59%) 
Infections and infestations     
Bronchitis  1  9/320 (2.81%)  7/315 (2.22%) 
Nasopharyngitis  1  16/320 (5.00%)  12/315 (3.81%) 
Sinusitis  1  4/320 (1.25%)  10/315 (3.17%) 
Upper respiratory tract infection  1  30/320 (9.38%)  27/315 (8.57%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  8/320 (2.50%)  7/315 (2.22%) 
Nervous system disorders     
Headache  1  26/320 (8.13%)  20/315 (6.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Sorscher
Organization: Salix
Phone: 919-862-1827
EMail: david.sorscher@salix.com
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00724126     History of Changes
Other Study ID Numbers: RFIB3008
First Submitted: July 26, 2008
First Posted: July 29, 2008
Results First Submitted: June 30, 2014
Results First Posted: July 28, 2014
Last Update Posted: November 28, 2019