Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD)

Exclusion Criteria

• •Patients were excluded from the study if they met any of the following criteria:
• •1. Fever (\> 100.4F or 38C) or presence of signs and symptoms of systemic infection Note: antipyretic medication should not have been administered in the 6 hours before this assessment
• •2. Known or suspected infection with non-bacterial pathogen before randomization
• •3. Presence of diarrhea for \> 72 hours duration
• •4. Presence of grossly bloody stool
• •5. Presence of moderate to severe dehydration (i.e., presence of orthostatic hypotension and/or dehydration requiring treatment with intravenous fluids)
• •6. History of ulcerative colitis, diarrhea-predominant irritable bowel syndrome, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea. Note: lactose intolerance treated with lactase supplements or a lactose-free diet were not excluded if these regimens were maintained during the study.
• •7. Receiving more than two doses of an antidiarrheal medication (e.g., antimotility, absorbent, adsorbent, antisecretory, or probiotics) within 24 hours before randomization
• •8. Receiving one or more of the following antibiotics, which are active against gram negative bacteria TMP-SMX, fluorquinolone, azithromycin or rifaximin within 7 days before randomization
• •9. Females pregnant or breast feeding or not using adequate birth control
• •10. Known intolerance/hypersensitivity/resistance to rifamycin or rifamycin-related antibiotics or to any excipient included in the study medications
• •11. Patients unable or unwilling to comply with study protocol (e.g., alcoholism, mental illness, travel schedule)
• •12. Participation in a clinical study with another investigational drug in the 30 days prior to randomization or while participating in this study
• •13. Previous participation in this study