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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 15, 2007

Last Updated Date

September 22, 2010

Start Date ^ICMJE

December 2006

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Time to Last Unformed Stool (TLUS)
Clinical cure based on relief of signs and symptoms
Microbiologic eradication rates
Safety Parameters

Change History

Complete list of historical versions of study NCT00448422 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

The clinical cure rate in the microbiologically-evaluable, intent-to-treat
(ITT), and modified intent-to-treat (mITT) populations.
The microbiologic-eradication rates in the microbiologic and mITT populations by subject and by pathogen, which will be determined by the
demonstrated absence of the original pathogens in the stool culture at the Test-of-Cure Visit.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Acute Bacterial Gastroenteritis

Intervention ^ICMJE

Drug: prulifloxacin

Tablet

Study Arm (s)

Experimental: 1
Tablet

Intervention: Drug: prulifloxacin
Placebo Comparator: 2
Tablet

Intervention: Drug: prulifloxacin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

268

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT00448422

Other Study ID Numbers ^ICMJE

OPT-099-002

Has Data Monitoring Committee

Responsible Party

Y.K. Shue, Optimer Pharmaceuticals

Study Sponsor ^ICMJE

Optimer Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Robert Steffen, MD

University of Zurich

Information Provided By

Optimer Pharmaceuticals

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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