Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers - Full Text View

Sponsor:	Optimer Pharmaceuticals
Information provided by:	Optimer Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00448422

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 (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 ]

Estimated Enrollment:	338
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
1: Experimental Tablet	Drug: prulifloxacin Tablet
2: Placebo Comparator 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
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

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

Locations

India, Goa
Goa Medical College
Bambolim, Goa, India

Sponsors and Collaborators

Optimer Pharmaceuticals

Investigators

Study Director:

Robert Steffen, MD

University of Zurich

More Information

No publications provided

Responsible Party:	Optimer Pharmaceuticals ( Y.K. Shue )
Study ID Numbers:	OPT-099-002
Study First Received:	March 15, 2007
Last Updated:	February 3, 2010
ClinicalTrials.gov Identifier:	NCT00448422 History of Changes
Health Authority:	United States: Food and Drug Administration; India: Ministry of Health; Guatemala: Ministerio de Salud Publica

Keywords provided by Optimer Pharmaceuticals:

Traveler's
Diarrhea

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Fluoroquinolones
Gastrointestinal Diseases

Therapeutic Uses
Enzyme Inhibitors
Gastroenteritis
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010