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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
Enrollment 623
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 314 309
Completed 292 283
Not Completed 22 26
Reason Not Completed
Adverse Event             7             8
Withdrawal by Subject             8             8
Lost to Follow-up             7             8
Noncompliance             0             1
Pregnancy             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 314 309 623
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 309 participants 623 participants
<=18 years
1
   0.3%
1
   0.3%
2
   0.3%
Between 18 and 65 years
275
  87.6%
274
  88.7%
549
  88.1%
>=65 years
38
  12.1%
34
  11.0%
72
  11.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 314 participants 309 participants 623 participants
45.5  (14.6) 46.2  (15.0) 45.8  (14.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 309 participants 623 participants
Female
222
  70.7%
235
  76.1%
457
  73.4%
Male
92
  29.3%
74
  23.9%
166
  26.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 309 participants 623 participants
American Indian or Alaska Native
0
   0.0%
2
   0.6%
2
   0.3%
Asian
1
   0.3%
2
   0.6%
3
   0.5%
Native Hawaiian or Other Pacific Islander
1
   0.3%
0
   0.0%
1
   0.2%
Black or African American
30
   9.6%
24
   7.8%
54
   8.7%
White
280
  89.2%
281
  90.9%
561
  90.0%
More than one race
2
   0.6%
0
   0.0%
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
Show Outcome Measure DataHide 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.
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 314 309
Measure Type: Number
Unit of Measure: percentage of responders
31.2 40.8
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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
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
Show Outcome Measure DataHide 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.
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 314 309
Measure Type: Number
Unit of Measure: percentage of responders
28.7 39.5
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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
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   8/314 (2.55%)   3/309 (0.97%) 
Gastrointestinal disorders     
Rectal haemorrhage  1  1/314 (0.32%)  0/309 (0.00%) 
Small intestinal obstruction  1  1/314 (0.32%)  0/309 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/314 (0.32%)  0/309 (0.00%) 
Cholecystitis acute  1  1/314 (0.32%)  0/309 (0.00%) 
Infections and infestations     
Gastroenteritis  1  1/314 (0.32%)  0/309 (0.00%) 
Injury, poisoning and procedural complications     
Road traffic accident  1  0/314 (0.00%)  1/309 (0.32%) 
Musculoskeletal and connective tissue disorders     
Costochondritis  1  0/314 (0.00%)  1/309 (0.32%) 
Fracture nonunion  1  1/314 (0.32%)  0/309 (0.00%) 
Nervous system disorders     
Amnesia  1  1/314 (0.32%)  0/309 (0.00%) 
Psychiatric disorders     
Alcohol withdrawal syndrome  1  0/314 (0.00%)  1/309 (0.32%) 
Schizophrenia, paranoid type  1  1/314 (0.32%)  0/309 (0.00%) 
Vascular disorders     
Labile hypertension  1  1/314 (0.32%)  0/309 (0.00%) 
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   101/314 (32.17%)   103/309 (33.33%) 
Gastrointestinal disorders     
Abdominal distension  1  7/314 (2.23%)  7/309 (2.27%) 
Abdominal pain  1  23/314 (7.32%)  19/309 (6.15%) 
Diarrhoea  1  15/314 (4.78%)  14/309 (4.53%) 
Flatulence  1  11/314 (3.50%)  6/309 (1.94%) 
Nausea  1  13/314 (4.14%)  22/309 (7.12%) 
Vomiting  1  8/314 (2.55%)  11/309 (3.56%) 
Infections and infestations     
Bronchitis  1  8/314 (2.55%)  6/309 (1.94%) 
Nasopharyngitis  1  18/314 (5.73%)  7/309 (2.27%) 
Sinusitis  1  12/314 (3.82%)  7/309 (2.27%) 
Upper respiratory tract infection  1  9/314 (2.87%)  8/309 (2.59%) 
Urinary tract infection  1  6/314 (1.91%)  7/309 (2.27%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  7/314 (2.23%)  3/309 (0.97%) 
Nervous system disorders     
Headache  1  16/314 (5.10%)  18/309 (5.83%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/314 (1.27%)  9/309 (2.91%) 
Nasal congestion  1  1/314 (0.32%)  7/309 (2.27%) 
Pharyngolaryngeal pain  1  12/314 (3.82%)  8/309 (2.59%) 
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
Name/Title: David Sorscher
Organization: Salix
Phone: 919-862-1827
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