NCT00392574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 15, 2015

Status Verified

August 1, 2010

Enrollment Period

1.5 years

First QC Date

October 24, 2006

Last Update Submit

April 27, 2015

Conditions

Acute Gastroenteritis in Adult Travelers

Keywords

Gastroenteritis

Outcome Measures

Primary Outcomes (1)

  • Time to last unformed stool

    Study days 1-3

Secondary Outcomes (2)

  • Clinical cure based on relief of signs and symptoms

    Study days 1-3

  • Microbiologic eradication rates

    Study days 1-3

Study Arms (2)

1

EXPERIMENTAL

Prulifloxacin

Drug: Prulifloxacin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PrulifloxacinDRUG

Tablet

1
PlaceboDRUG

Tablet

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Acute Bacterial Gastroenteritis;
  • Traveler from Industrialized Country;
  • Capable of giving Informed Consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INC Research

New Hope, Pennsylvania, 18938, United States

Location

MeSH Terms

Conditions

Gastroenteritis

Interventions

prulifloxacin

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Herbert Dupont, MD

    University of Texas

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 26, 2006

Study Start

August 1, 2006

Primary Completion

February 1, 2008

Study Completion

March 1, 2008

Last Updated

May 15, 2015

Record last verified: 2010-08

Locations

US(1)