None listed
Conditions
Interventions
• Placebo Comparator: Placebo
• Placebo (two matching tablets) orally twice daily for 3 days (72 hours)
• Experimental: Rifamycin SV MMX
• Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally
Sponsors
Santarus, Inc.,
Eligibility
Inclusion criteria
Inclusion criteria: •• Male and female patients 18 years of age or older. • Female and male patients of child-bearing potential must agree to use effective method of birth control(this method must be approved by the investigator an may include the abstinence) • Men and women fertile patients must agree to use an effective contraceptive method (this method must be approved by the investigator and may include abstinence). • Recent travel (i.e., must be within 30 days of randomization) from an industrialized country. • Experiencing signs and symptoms indicative of acute bacterial diarrhea, defined as at least three unformed, watery or soft stools, with the 24 hours preceding randomization and the duration of illness ≤ 72 hours before. • Capable of willing to give informed consent
Exclusion criteria
Exclusion criteria: • • Fever (> 100.4 ° F to 38 ° C) or presence of signs and symptoms of systemic infection. • Known or suspected with non- bacterial pathogen before randomization. • Presence of diarrhea for > 72 hours duration • Presence of grossly bloody stool. • Females pregnant or breast or not using adequate birth control. • Known intolerance / hypersensitivity / resistance to rifamycin or rifampin-related antibiotics.
Contacts
Public ContactNicolas Emilio Sandoval
INC Research Peru S.A.C
Outcome results
None listed