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Sponsored by: |
Optimer Pharmaceuticals |
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Information provided by: | Optimer Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00392574 |
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 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), 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 |
Estimated Enrollment: | 375 |
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 |
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1: Experimental
Prulifloxacin
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Drug: Prulifloxacin
Tablet
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2: Placebo Comparator
Placebo
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Drug: Prulifloxacin
Tablet
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Optimer Pharmaceuticals ( Y. K. Shue ) |
Study ID Numbers: | OPT-099-001 |
Study First Received: | October 24, 2006 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00392574 History of Changes |
Health Authority: | United States: Food and Drug Administration; Mexico: National Institute of Public Health, Health Secretariat; Peru: Instituto Nacional de Salud |
Gastroenteritis |
Digestive System Diseases Diarrhea Gastrointestinal Diseases Giardiasis Gastroenteritis |
Digestive System Diseases Gastrointestinal Diseases Gastroenteritis |