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Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers

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ClinicalTrials.gov Identifier: NCT00448422
Recruitment Status : Completed
First Posted : March 16, 2007
Last Update Posted : September 27, 2010
Sponsor:
Information provided by:
Optimer Pharmaceuticals LLC

Study Description
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Brief Summary:
The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of patients with acute bacterial gastroenteritis (traveler's diarrhea.

Condition or disease Intervention/treatment Phase
Acute Bacterial Gastroenteritis Drug: prulifloxacin Phase 3

Detailed Description:
This double-blind trial will compare the safety and efficacy of prulifloxacin versus placebo in adult travelers with acute gastroenteritis characterized by diarrhea with one or more of the following signs or symptoms: nausea, vomiting, abdominal pain or cramping, fecal urgency, moderate to severe other gastrointestinal-related symptoms, or tenesmus of <72 hours duration.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized Study to Compare the Safety and Efficacy of Prulifloxacin Versus Placebo in the Treatment of Acute Gastroenteritis in Adult Travelers
Study Start Date : December 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Tablet
 Drug: prulifloxacin
Tablet
Placebo Comparator: 2
Tablet
 Drug: prulifloxacin
Tablet


Outcome Measures
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Primary Outcome Measures :
  1. Time to Last Unformed Stool (TLUS) [ Time Frame: End of Therapy ]

Secondary Outcome Measures :
  1. Microbiologic eradication rates [ Time Frame: End of therapy/study ]
  2. Clinical cure based on relief of signs and symptoms [ Time Frame: End of therapy/study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of acute bacterial gastroenteritis
  • Traveler from an industrialized country
  • Capable of giving Informed Consent

Exclusion Criteria:

  • Fever (>100.3 degrees)
  • Pregnant or Breast Feeding or Not using adequate birth control
  • Known or Suspected (co-)Infection with non-bacterial pathogen
  • Symptoms of acute gastroenteritis of >72 hours duration
  • Bloody Diarrhea
  • Concomitant antibacterial with activity against enteric bacterial pathogens
  • History of IBD
  • Unable/Unwilling to comply with study protocol
  • Greater than two doses of an antidiarrheal medication within 24 hours
  • > 2 doses of anti-diarrheal medication within 24 hours
  • Antimicrobial treatment within 30 days
Contacts and Locations
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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): NCT00448422


Locations
India
Goa Medical College
Bambolim, Goa, India
Sponsors and Collaborators
Optimer Pharmaceuticals LLC
Investigators
Study Director: Robert Steffen, MD University of Zurich
More Information
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Responsible Party: Y.K. Shue, Optimer Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00448422     History of Changes
Other Study ID Numbers: OPT-099-002
First Posted: March 16, 2007    Key Record Dates
Last Update Posted: September 27, 2010
Last Verified: September 2010

Keywords provided by Optimer Pharmaceuticals LLC:
Traveler's
Diarrhea

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Prulifloxacin
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
 Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors