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Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's Diarrhea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00392574
First Posted: October 26, 2006
Last Update Posted: May 15, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of subjects with acute bacterial gastroenteritis.

Condition Intervention Phase
Acute Gastroenteritis in Adult Travelers Drug: Prulifloxacin Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Time to last unformed stool [ Time Frame: Study days 1-3 ]

Secondary Outcome Measures:
  • Clinical cure based on relief of signs and symptoms [ Time Frame: Study days 1-3 ]
  • Microbiologic eradication rates [ Time Frame: Study days 1-3 ]

Enrollment: 282
Study Start Date: August 2006
Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Prulifloxacin
Drug: Prulifloxacin
Tablet
Placebo Comparator: 2
Placebo
Drug: Placebo
Tablet

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 gas-related symptoms, or tenesmus of ≤72 hours duration.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosis of Acute Bacterial Gastroenteritis;
  • Traveler from 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 Gastroenteritis of >72 hours;
  • Bloody Diarrhea;
  • Concomitant antibacterial with activity against enteric bacterial pathogens;
  • History of IBD;
  • Unable/Unwilling to comply with study protocol;
  • > 2 doses of anti-diarrheal medication within 24 hours;
  • Antimicrobial Treatment within 30 days
  Contacts and Locations
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): NCT00392574


Locations
United States, Pennsylvania
INC Research
New Hope, Pennsylvania, United States, 18938
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Herbert Dupont, MD University of Texas
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00392574     History of Changes
Other Study ID Numbers: OPT-099-001
First Submitted: October 24, 2006
First Posted: October 26, 2006
Last Update Posted: May 15, 2015
Last Verified: August 2010

Keywords provided by Merck Sharp & Dohme Corp.:
Gastroenteritis

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