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

This study is currently recruiting participants.
Verified April 2013 by Dr. Falk Pharma GmbH
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01208922
First received: September 23, 2010
Last updated: April 26, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Traveler's Diarrhea
 Drug: Rifamycin SV MMX
Drug: Ciprofloxacin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • Time to Last Unformed Stool (TLUS) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical cure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 776
Study Start Date: October 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Rifamycin SV MMX
800 mg per day
Active Comparator: B Drug: Ciprofloxacin
1 g per day

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent,
  • Signs or symptoms of indication of acute bacterial diarrhea (traveller's diarrhea)

Exclusion Criteria:

  • Fever,
  • Grossly bloody stool,
  • Females pregnant or breast feeding,
  • Participation in an other clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208922

Locations
India
Site 106 Recruiting
Bangalore, Karnataka, India
Contact: Arun Narayan, Dr.         drarunnarayan@gmail.com    
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
Principal Investigator: Professor Robert Steffen, M. D. University of Zurich, Switzerland
  More Information

No publications provided

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01208922     History of Changes
Other Study ID Numbers: RIT-1/AID
Study First Received: September 23, 2010
Last Updated: April 26, 2013
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Diarrhea
Dysentery
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ciprofloxacin
Rifamycins
 Rifamycin SV
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Anti-Bacterial Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013