Status:
COMPLETED
Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
Traveler's Diarrhea
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
835 Patients enrolled
Trial Details
Trial ID
NCT01208922
Start Date
November 1 2010
End Date
May 1 2016
Last Update
February 27 2019
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 401
Quito, Ecuador
2
Site 200
Quetzaltenango, Guatemala
3
Site 101
Mapusa, Karaswada, India
4
Site 124
Ajmer, India