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
  Purpose

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 Intervention Phase
Acute Bacterial Gastroenteritis
Drug: prulifloxacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Optimer Pharmaceuticals:

Primary Outcome Measures:
  • Time to Last Unformed Stool (TLUS) [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 268
Study Start Date: December 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Tablet
Drug: prulifloxacin
Tablet
Placebo Comparator: 2
Tablet
Drug: prulifloxacin
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 other gastrointestinal-related symptoms, or tenesmus of <72 hours duration.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448422

Locations
India
Goa Medical College
Bambolim, Goa, India
Sponsors and Collaborators
Optimer Pharmaceuticals
Investigators
Study Director: Robert Steffen, MD University of Zurich
  More Information

No publications provided

Responsible Party: Y.K. Shue, Optimer Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00448422     History of Changes
Other Study ID Numbers: OPT-099-002
Study First Received: March 15, 2007
Last Updated: September 22, 2010
Health Authority: United States: Food and Drug Administration
India: Ministry of Health
Guatemala: Ministerio de Salud Publica

Keywords provided by Optimer Pharmaceuticals:
Traveler's
Diarrhea

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

ClinicalTrials.gov processed this record on July 31, 2014