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

Acute Bacterial Gastroenteritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448422
• Other study ID #: OPT-099-002
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2007
• Last updated: September 22, 2010
• Start date: December 2006
• Est. completion date: August 2008

Study information

• Verified date: September 2010
• Source: Optimer Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Ministry of HealthGuatemala: Ministerio de Salud Publica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bacterial Gastroenteritis
• Gastroenteritis

Intervention

Drug:
• prulifloxacin
Tablet

Locations

Country	Name	City	State
India	Goa Medical College	Bambolim	Goa

Sponsors (1)

Lead Sponsor	Collaborator
Optimer Pharmaceuticals LLC

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Last Unformed Stool (TLUS)		End of Therapy	No
Secondary	Microbiologic eradication rates		End of therapy/study	No
Secondary	Clinical cure based on relief of signs and symptoms		End of therapy/study	No