A Randomised, Double-blind, Double-dummy, Multi-centre, Comparative Parallel-group Study to Evaluate the Efficacy and Safety of Oral Daily Rifamycin SV-MMX® 400 mg b.i.d. vs. Ciprofloxacin 500 mg b.i.d. in the Treatment of Acute Infectious Diarrhoea in Travellers (ERASE)

NCT01208922 Phase 3 COMPLETED Results posted

The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea.

Details

Lead sponsor	Dr. Falk Pharma GmbH
Phase	Phase 3
Status	COMPLETED
Enrolment	835
Start date	2010-11
Completion	2016-05

Conditions

• Traveler's Diarrhea

Interventions

• Rifamycin SV-MMX®
• Ciprofloxacin

Primary outcomes

• Time to Last Unformed Stool (TLUS) — 5 days
  Time to Last Unformed Stool (TLUS), defined as the interval in hours between the first dose of study drug and the last unformed stool passed, after which clinical cure was declared.

Countries

Ecuador, Guatemala, India