Status:
COMPLETED
Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 substanti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
525 Patients enrolled
Trial Details
Trial ID
NCT00269412
Start Date
December 1 2005
End Date
September 1 2008
Last Update
November 25 2019
Active Locations (67)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
2
Premeire Pharmaceutical Research
Tempe, Arizona, United States, 85282
3
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
4
Lovelace Scientific Resources
Irvine, California, United States, 92618