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

NCT ID: NCT00448422

Last Updated: 2010-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-08-31

Brief Summary

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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

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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.

Conditions

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Acute Bacterial Gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Tablet

Group Type EXPERIMENTAL

prulifloxacin

Intervention Type DRUG

Tablet

2

Tablet

Group Type PLACEBO_COMPARATOR

prulifloxacin

Intervention Type DRUG

Tablet

Interventions

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prulifloxacin

Tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role lead

Responsible Party

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Optimer Pharmaceuticals

Principal Investigators

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Robert Steffen, MD

Role: STUDY_DIRECTOR

University of Zurich

Locations

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Goa Medical College

Bambolim, Goa, India

Site Status

Countries

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India

Other Identifiers

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OPT-099-002

Identifier Type: -

Identifier Source: org_study_id