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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01208922
First received: September 23, 2010
Last updated: May 26, 2017
Last verified: May 2017
  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
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

Resource links provided by NLM:


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

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

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

Enrollment: 835
Study Start Date: October 2010
Study Completion Date: May 2017
Primary Completion Date: January 2016 (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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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: May 26, 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

ClinicalTrials.gov processed this record on August 17, 2017