Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's Diarrhea - Full Text View

Sponsor:	Optimer Pharmaceuticals
Information provided by:	Optimer Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00392574

Purpose

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.

Condition	Intervention	Phase
Acute Gastroenteritis in Adult Travelers	Drug: Prulifloxacin Drug: Placebo	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea Gastroenteritis

Drug Information available for: NM 441

U.S. FDA Resources

Further study details as provided by Optimer Pharmaceuticals:

Primary Outcome Measures:

Time to last unformed stool [ Time Frame: Study days 1-3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical cure based on relief of signs and symptoms [ Time Frame: Study days 1-3 ] [ Designated as safety issue: No ]
Microbiologic eradication rates [ Time Frame: Study days 1-3 ] [ Designated as safety issue: No ]

Enrollment:	282
Study Start Date:	August 2006
Study Completion Date:	March 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Prulifloxacin	Drug: Prulifloxacin Tablet
Placebo Comparator: 2 Placebo	Drug: Placebo Tablet

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 gas-related symptoms, or tenesmus of ≤72 hours duration.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Acute Bacterial Gastroenteritis;
Traveler from 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392574

Locations

United States, Pennsylvania
INC Research
New Hope, Pennsylvania, United States, 18938

Sponsors and Collaborators

Optimer Pharmaceuticals

Investigators

Study Director:

Herbert Dupont, MD

University of Texas

More Information

No publications provided

Responsible Party:	Y. K. Shue, Optimer Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00392574 History of Changes
Other Study ID Numbers:	OPT-099-001
Study First Received:	October 24, 2006
Last Updated:	August 31, 2010
Health Authority:	United States: Food and Drug Administration; Mexico: National Institute of Public Health, Health Secretariat; Peru: Instituto Nacional de Salud

Keywords provided by Optimer Pharmaceuticals:

Gastroenteritis

Additional relevant MeSH terms:

Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012