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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01208922
Recruitment Status : Completed
First Posted : September 24, 2010
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Traveler's Diarrhea Drug: Rifamycin SV MMX Drug: Ciprofloxacin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 835 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2010
Primary Completion Date : January 2016
Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: Rifamycin SV MMX
800 mg per day
Active Comparator: B Drug: Ciprofloxacin
1 g per day



Primary Outcome Measures :
  1. Time to Last Unformed Stool (TLUS) [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Clinical cure [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208922


Locations
Ecuador
Site 400
Quito, Ecuador
Site 401
Quito, Ecuador
Guatemala
Site 201
Antigua, Guatemala
Site 202
Panajachel, Guatemala
Site 200
Quetzaltenango, Guatemala
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
Study Chair: Professor Robert Steffen, M. D. University of Zurich, Switzerland

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01208922     History of Changes
Other Study ID Numbers: RIT-1/AID
First Posted: September 24, 2010    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

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
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antirheumatic Agents