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

Acute Gastroenteritis in Adult Travelers 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: NCT00392574
• Other study ID #: OPT-099-001
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2006
• Last updated: April 27, 2015
• Start date: August 2006
• Est. completion date: March 2008

Study information

• Verified date: August 2010
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationMexico: National Institute of Public Health, Health SecretariatPeru: Instituto Nacional de Salud
• 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 subjects with acute bacterial gastroenteritis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: March 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Gastroenteritis in Adult Travelers
• Gastroenteritis

Intervention

Drug:
• Prulifloxacin
Tablet
• Placebo
Tablet

Locations

Country	Name	City	State
United States	INC Research	New Hope	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to last unformed stool		Study days 1-3	No
Secondary	Clinical cure based on relief of signs and symptoms		Study days 1-3	No
Secondary	Microbiologic eradication rates		Study days 1-3	No