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

This study has been completed.
Sponsor:
Information provided by:
Optimer Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00448422
First received: March 15, 2007
Last updated: September 22, 2010
Last verified: September 2010

March 15, 2007
September 22, 2010
December 2006
August 2008   (final data collection date for primary outcome measure)
Time to Last Unformed Stool (TLUS) [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]
  • Time to Last Unformed Stool (TLUS)
  • Clinical cure based on relief of signs and symptoms
  • Microbiologic eradication rates
  • Safety Parameters
Complete list of historical versions of study NCT00448422 on ClinicalTrials.gov Archive Site
  • Microbiologic eradication rates [ Time Frame: End of therapy/study ] [ Designated as safety issue: No ]
  • Clinical cure based on relief of signs and symptoms [ Time Frame: End of therapy/study ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Bacterial Gastroenteritis
Drug: prulifloxacin
Tablet
  • Experimental: 1
    Tablet
    Intervention: Drug: prulifloxacin
  • Placebo Comparator: 2
    Tablet
    Intervention: Drug: prulifloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
268
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00448422
OPT-099-002
No
Y.K. Shue, Optimer Pharmaceuticals
Optimer Pharmaceuticals
Not Provided
Study Director: Robert Steffen, MD University of Zurich
Optimer Pharmaceuticals
September 2010

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