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

Primary Purpose

Acute Gastroenteritis in Adult Travelers

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Prulifloxacin
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gastroenteritis in Adult Travelers focused on measuring Gastroenteritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • INC Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Prulifloxacin

Placebo

Outcomes

Primary Outcome Measures

Time to last unformed stool

Secondary Outcome Measures

Clinical cure based on relief of signs and symptoms
Microbiologic eradication rates

Full Information

First Posted
October 24, 2006
Last Updated
April 27, 2015
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00392574
Brief Title
Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's Diarrhea
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 subjects with acute bacterial gastroenteritis.
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 gas-related symptoms, or tenesmus of ≤72 hours duration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastroenteritis in Adult Travelers
Keywords
Gastroenteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Prulifloxacin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Prulifloxacin
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Time to last unformed stool
Time Frame
Study days 1-3
Secondary Outcome Measure Information:
Title
Clinical cure based on relief of signs and symptoms
Time Frame
Study days 1-3
Title
Microbiologic eradication rates
Time Frame
Study days 1-3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Dupont, MD
Organizational Affiliation
University of Texas
Official's Role
Study Director
Facility Information:
Facility Name
INC Research
City
New Hope
State/Province
Pennsylvania
ZIP/Postal Code
18938
Country
United States

12. IPD Sharing Statement

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

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