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

Dr. Falk Pharma GmbH19 sites in 3 countries835 target enrollmentNovember 2010

ConditionsTraveler's Diarrhea

InterventionsRifamycin SV-MMX®Ciprofloxacin

DrugsRifamycin SV-MMX®Ciprofloxacin

Overview

Phase: Phase 3
Intervention: Rifamycin SV-MMX®
Conditions: Traveler's Diarrhea
Sponsor: Dr. Falk Pharma GmbH
Enrollment: 835
Locations: 19
Primary Endpoint: Time to Last Unformed Stool (TLUS)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

May 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dr. Falk Pharma GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent,
•Men or women between 18 and 85 years of age,
•History of arriving from their country of residence in the industrialized part of the world within the past 4 weeks,
•Presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or soft stools accompanied by symptoms within 24 hours preceding randomisation with duration of illness ≤ 72 hours),
•Presence of one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, fecal urgency),
•Women of childbearing potential had to apply during the entire duration of the study a highly effective method of birth control

Exclusion Criteria

•Residency in any country with high incidence rate of TD within the past 6 months,
•Fever (defined as a body (oral) temperature \>100.4°F or 38.0°C; antipyretic medication should not have been administered in the 6 hours prior to this assessment),
•Known or suspected infection with non-bacterial pathogen,
•Presence of diarrhoea of \>72 hours duration,
•Presence of grossly bloody stool,
•Presence of moderate or severe dehydration (i.e. symptoms of hypovolemia such as orthostatic hypotension, dizziness or wrinkling of skin),
•History of inflammatory bowel disease or celiac disease,

Arms & Interventions

Group A

Rifamycin SV-MMX® 200 mg tablets

Intervention: Rifamycin SV-MMX®

Group B

Ciprofloxacin 500 mg capsules

Intervention: Ciprofloxacin

Outcomes

Primary Outcomes

Time to Last Unformed Stool (TLUS)

Time Frame: 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.