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 LLC

ClinicalTrials.gov Identifier:

NCT00448422

First received: March 15, 2007

Last updated: September 22, 2010

Last verified: September 2010

History of Changes

Purpose

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.

Condition	Intervention	Phase
Acute Bacterial Gastroenteritis	Drug: prulifloxacin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) 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: Gastroenteritis

U.S. FDA Resources

Further study details as provided by Optimer Pharmaceuticals LLC:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]


Enrollment:	268
Study Start Date:	December 2006
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Tablet	Drug: prulifloxacin Tablet
Placebo Comparator: 2 Tablet	Drug: prulifloxacin 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 other gastrointestinal-related symptoms, or tenesmus of <72 hours duration.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448422

Locations


India
Goa Medical College
Bambolim, Goa, India

Sponsors and Collaborators

Optimer Pharmaceuticals LLC

Investigators


Study Director:	Robert Steffen, MD	University of Zurich

More Information


Responsible Party:	Y.K. Shue, Optimer Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00448422 History of Changes
Other Study ID Numbers:	OPT-099-002
Study First Received:	March 15, 2007
Last Updated:	September 22, 2010
Health Authority:	United States: Food and Drug Administration India: Ministry of Health Guatemala: Ministerio de Salud Publica

Keywords provided by Optimer Pharmaceuticals LLC:


Traveler's Diarrhea

Additional relevant MeSH terms:


Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Prulifloxacin Fluoroquinolones Anti-Bacterial Agents Anti-Infective Agents	Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 29, 2016

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