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

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

Tracking Information
First Submitted Date  ICMJE March 15, 2007
First Posted Date  ICMJE March 16, 2007
Last Update Posted Date September 27, 2010
Study Start Date  ICMJE December 2006
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2008)
Time to Last Unformed Stool (TLUS) [ Time Frame: End of Therapy ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2007)
  • 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: January 16, 2008)
  • Microbiologic eradication rates [ Time Frame: End of therapy/study ]
  • Clinical cure based on relief of signs and symptoms [ Time Frame: End of therapy/study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2007)
  • The clinical cure rate in the microbiologically-evaluable, intent-to-treat
  • (ITT), and modified intent-to-treat (mITT) populations.
  • The microbiologic-eradication rates in the microbiologic and mITT populations by subject and by pathogen, which will be determined by the
  • demonstrated absence of the original pathogens in the stool culture at the Test-of-Cure Visit.
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 vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers
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 patients with acute bacterial gastroenteritis (traveler's diarrhea.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Bacterial Gastroenteritis
Intervention  ICMJE Drug: prulifloxacin
Tablet
Study Arms  ICMJE
  • Experimental: 1
    Tablet
    Intervention: Drug: prulifloxacin
  • Placebo Comparator: 2
    Tablet
    Intervention: Drug: prulifloxacin
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 27, 2010)
268
Original Enrollment  ICMJE
 (submitted: March 15, 2007)
244
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00448422
Other Study ID Numbers  ICMJE OPT-099-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Y.K. Shue, Optimer Pharmaceuticals
Study Sponsor  ICMJE Optimer Pharmaceuticals LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Steffen, MD University of Zurich
PRS Account Optimer Pharmaceuticals LLC
Verification Date September 2010

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