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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	December 22, 2005
Last Updated Date	December 6, 2007
Start Date ^†	December 2005
Current Primary Outcome Measures ^† (submitted: December 22, 2005)	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.
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00269412 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: June 21, 2007)	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; 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; 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.
Original Secondary Outcome Measures ^† (submitted: December 22, 2005)	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; • 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; • 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

Descriptive Information
Brief Title ^†	Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome
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
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.
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 Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Condition ^†	Irritable Bowel Syndrome
Intervention ^†	Drug: Rifaximin
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	525
Completion Date
Primary Completion Date
Eligibility Criteria ^†	Inclusion Criteria: Male or female subject 18 years of age or older. Irritable bowel syndrome confirmed by the Rome II Criteria Lower endoscopic examination that demonstrates normal colonic anatomy Exclusion Criteria: Subject has exclusively constipation-predominant IBS (CIBS) that is characterized by < 3 bowel movements/week or hard and lumpy stools. Subject has alternating IBS, but is currently presenting with constipation associated IBS symptoms. 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. Subjects has a positive stool culture for O & P (ovum and parasite) and/or Clostridium difficile Subject has failed to record 2 negative weekly global assessments during the past 10 days prior to randomization.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00269412
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	Salix Pharmaceuticals
Collaborators ^††
Investigators ^†
Information Provided By	Salix Pharmaceuticals
Verification Date	December 2007
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.