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Study 2 of 5 for search of: | "Optimer Pharmaceuticals" [Exact] |
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Sponsored by: |
Optimer Pharmaceuticals |
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Information provided by: | Optimer Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00448422 |
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 |
Estimated Enrollment: | 338 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Capsule
|
Drug: prulifloxacin
capsule
|
2: Placebo Comparator
Capsule
|
Drug: prulifloxacin
capsule
|
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.
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-099-002 |
Study First Received: | March 15, 2007 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00448422 |
Health Authority: | United States: Food and Drug Administration; India: Ministry of Health; Guatemala: Ministerio de Salud Publica |
Traveler's Diarrhea |
Digestive System Diseases Diarrhea Gastrointestinal Diseases Gastroenteritis |