NCT00448422

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
268

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

September 27, 2010

Status Verified

September 1, 2010

Enrollment Period

1.7 years

First QC Date

March 15, 2007

Last Update Submit

September 22, 2010

Conditions

Acute Bacterial Gastroenteritis

Keywords

Traveler'sDiarrhea

Outcome Measures

Primary Outcomes (1)

  • Time to Last Unformed Stool (TLUS)

    End of Therapy

Secondary Outcomes (2)

  • Microbiologic eradication rates

    End of therapy/study

  • Clinical cure based on relief of signs and symptoms

    End of therapy/study

Study Arms (2)

1

EXPERIMENTAL

Tablet

Drug: prulifloxacin

2

PLACEBO COMPARATOR

Tablet

Drug: prulifloxacin

Interventions

prulifloxacinDRUG

Tablet

12

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 an 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goa Medical College

Bambolim, Goa, India

Location

MeSH Terms

Conditions

Diarrhea

Interventions

prulifloxacin

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Steffen, MD

    University of Zurich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 15, 2007

First Posted

March 16, 2007

Study Start

December 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

September 27, 2010

Record last verified: 2010-09

Locations

IN(1)