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

Primary Purpose

Acute Bacterial Gastroenteritis

Status

Completed

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

prulifloxacin

About this trial

This is an interventional treatment trial for Acute Bacterial Gastroenteritis focused on measuring Traveler's, Diarrhea

Eligibility Criteria

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

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

Sites / Locations

Goa Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Tablet

Outcomes

Primary Outcome Measures

Time to Last Unformed Stool (TLUS)

Secondary Outcome Measures

Microbiologic eradication rates

Clinical cure based on relief of signs and symptoms

Full Information

NCT ID

NCT00448422

First Posted

March 15, 2007

Last Updated

September 22, 2010

Sponsor

Optimer Pharmaceuticals LLC

1. Study Identification

Unique Protocol Identification Number

NCT00448422

Brief Title

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

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

September 2010

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Optimer Pharmaceuticals LLC

4. Oversight

Data Monitoring Committee

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 patients with acute bacterial gastroenteritis (traveler's diarrhea.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Bacterial Gastroenteritis

Keywords

Traveler's, Diarrhea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

268 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Tablet

Arm Title

Arm Type

Placebo Comparator

Arm Description

Tablet

Intervention Type

Drug

Intervention Name(s)

prulifloxacin

Intervention Description

Tablet

Primary Outcome Measure Information:

Title

Time to Last Unformed Stool (TLUS)

Time Frame

End of Therapy

Secondary Outcome Measure Information:

Title

Microbiologic eradication rates

Time Frame

End of therapy/study

Title

Clinical cure based on relief of signs and symptoms

Time Frame

End of therapy/study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Steffen, MD

Organizational Affiliation

University of Zurich

Official's Role

Study Director

Facility Information:

Facility Name

Goa Medical College

City

Bambolim

State/Province

Goa

Country

India

12. IPD Sharing Statement

Learn more about this trial

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

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