Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea

Phase 3

Completed

• Conditions: Traveler's Diarrhea
• Interventions: Drug: Rifamycin SV-MMX®; Drug: Ciprofloxacin

• Registration Number: NCT01208922
• Lead Sponsor: Dr. Falk Pharma GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-09-23
• Study First Posted: 2010-09-24
• Study Start: 2010-11
• Primary Completion: 2016-01
• Study Completion: 2016-05
• Results First Submitted: 2018-02-08
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-16
• Last Update Submitted: 2018-10-16
• Results First Posted: 2019-02-27
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 835

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Rifamycin SV-MMX®	Rifamycin SV-MMX® 200 mg tablets
Group B	Ciprofloxacin	Ciprofloxacin 500 mg capsules

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Clinical Cure	5 days	Clinical Cure Rate: 24-hour period with no clinical symptoms except mild flatulence, no fever, no watery stools and no more than 2 soft stools OR 48-hour period with no stools or only formed stools, and no fever, with our without symptoms of enteric infection.

Trial Locations

Locations (19)

Site 122; 🇮🇳 Panaji, India

Site 102; 🇮🇳 Pondichéry, India

Site 103; 🇮🇳 Vijayawada, India

Site 101; 🇮🇳 Mapusa, Karaswada, India

Site 120; 🇮🇳 Calangute, India

Site 116; 🇮🇳 Lucknow, India

Site 119; 🇮🇳 Salcette, India

Site 118; 🇮🇳 Bardez, India

Site 107; 🇮🇳 Margao, India

Site 110; 🇮🇳 Margao, India

Site 111; 🇮🇳 Tiswadi, India

Site 401; 🇪🇨 Quito, Ecuador

Site 200; 🇬🇹 Quetzaltenango, Guatemala

Site 124; 🇮🇳 Ajmer, India

Site 104; 🇮🇳 Hyderabad, India

Site 114; 🇮🇳 Kolkata, India

Site 123; 🇮🇳 New Delhi, India

Site 115; 🇮🇳 Pushkar, India

Site 109; 🇮🇳 Varanasi, India