Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
NCT ID: NCT01208922
Last Updated: 2019-02-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
835 participants
INTERVENTIONAL
2010-11-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A
Rifamycin SV-MMX® 200 mg tablets
Rifamycin SV-MMX®
2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
Group B
Ciprofloxacin 500 mg capsules
Ciprofloxacin
1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
Interventions
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Rifamycin SV-MMX®
2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
Ciprofloxacin
1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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,
18 Years
85 Years
ALL
No
Sponsors
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Dr. Falk Pharma GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Professor Robert Steffen, M. D.
Role: PRINCIPAL_INVESTIGATOR
University of Zurich, Switzerland
Locations
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Site 401
Quito, , Ecuador
Site 200
Quetzaltenango, , Guatemala
Site 101
Mapusa, Karaswada, India
Site 124
Ajmer, , India
Site 118
Bardez, , India
Site 120
Calangute, , India
Site 104
Hyderabad, , India
Site 114
Kolkata, , India
Site 116
Lucknow, , India
Site 107
Madgaon, , India
Site 110
Madgaon, , India
Site 123
New Delhi, , India
Site 122
Panjim, , India
Site 102
Puducherry, , India
Site 115
Pushkar, , India
Site 119
Salcette, , India
Site 111
Tiswadi, , India
Site 109
Varanasi, , India
Site 103
Vijayawada, , India
Countries
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Other Identifiers
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RIT-1/AID
Identifier Type: -
Identifier Source: org_study_id
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