Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00269412
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : December 23, 2009
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
This is placebo-controlled study of three rifaximin doses in patients with DIBS. Subjects will be randomized to receive daily doses of placebo BID, rifaximin 275 mg BID, rifaximin 550 mg BID, or 1100 mg BID for 14 days. These four groups will subsequently receive an additional two weeks of placebo for a total of 4 weeks of treatment. A fifth group of subjects will receive rifaximin 550 mg BID for a period of 28 days. Subjects who successfully respond to treatment at the end of the 28-day Treatment Phase will be followed in a Post-treatment Phase that includes study visits during Weeks 6, 8, 12 and 16. Subjects who relapse during the Post-treatment Phase will be discontinued from the study.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Rifaximin Phase 2

Detailed Description:
While IBS is one of the most common chronic medical conditions the etiology of IBS is unknown. Although not a life-threatening illness, IBS is considered to be a serious condition that has a substantial impact on a subject's day-to-day function. IBS is characterized by abdominal pain and altered bowel habits, including diarrhea, constipation, or alternating diarrhea and constipation. Symptoms are typically intermittent but may be continuous.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess The Efficacy and Safety of Three Different Doses (275, 550 AND 1100 MG) of Rifaximin Administered BID For Either Two or Four Weeks in The Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome
Study Start Date : December 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Rifaximin
U.S. FDA Resources

Primary Outcome Measures :
  1. The primary objective of this trial is to evaluate the efficacy of a 14-day course of oral rifaximin at 550 mg BID versus placebo in providing adequate relief from Diarrhea-associated IBS (DIBS) symptoms.

Secondary Outcome Measures :
  1. To evaluate the dose-response relationship of placebo administered for 28 days and rifaximin administered at 275 mg BID, 550 mg BID, or 1100 mg BID for 14 days;
  2. to evaluate the efficacy of 550 mg BID for 4 weeks to determine if there are any differences when treatment is extended for an additional 2-week period when compared to a similar dosing regimen for 2 weeks;
  3. to evaluate the durability of response over a 12-week Post-treatment Phase in subjects with DIBS who achieved a response during the acute Treatment Phase of the study.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female subject 18 years of age or older.
  2. Irritable bowel syndrome confirmed by the Rome II Criteria
  3. Lower endoscopic examination that demonstrates normal colonic anatomy

Exclusion Criteria:

  1. Subject has exclusively constipation-predominant IBS (CIBS) that is characterized by < 3 bowel movements/week or hard and lumpy stools.
  2. Subject has alternating IBS, but is currently presenting with constipation associated IBS symptoms.
  3. Subject has had adequate control of their DIBS and their symptom of bloating the week preceding the screening visit or at the time of randomization. Bloating includes the following symptoms: abdominal fullness, bloating, gas, or swelling.
  4. Subjects has a positive stool culture for O & P (ovum and parasite) and/or Clostridium difficile
  5. Subject has failed to record 2 negative weekly global assessments during the past 10 days prior to randomization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00269412

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Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00269412     History of Changes
Other Study ID Numbers: RFIB2001
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Irritable bowel syndrome

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents