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

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: NCT00392574
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE October 24, 2006
First Posted Date  ICMJE October 26, 2006
Last Update Posted Date May 15, 2015
Study Start Date  ICMJE August 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2010)
Time to last unformed stool [ Time Frame: Study days 1-3 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2006)
  • Time to Last Unformed Stool (TLUS)
  • Clinical cure based on relief of signs and symptoms
  • Microbiologic eradication rates.
  • Safety Parameters
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2010)
  • Clinical cure based on relief of signs and symptoms [ Time Frame: Study days 1-3 ]
  • Microbiologic eradication rates [ Time Frame: Study days 1-3 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2006)
Clinical cure rate in microbiologically evaluable,ITT and MITT populations
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's Diarrhea
Official Title  ICMJE 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
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 subjects with acute bacterial gastroenteritis.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Gastroenteritis in Adult Travelers
Intervention  ICMJE
  • Drug: Prulifloxacin
    Tablet
  • Drug: Placebo
    Tablet
Study Arms  ICMJE
  • Experimental: 1
    Prulifloxacin
    Intervention: Drug: Prulifloxacin
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2010)
282
Original Enrollment  ICMJE
 (submitted: October 25, 2006)
375
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00392574
Other Study ID Numbers  ICMJE OPT-099-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Herbert Dupont, MD University of Texas
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP