Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448422
Status:
COMPLETED
Last Update Posted:
2010-09-27
First Post:
2007-03-15
Brief Title:
Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers
Sponsor:
Optimer Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Organization:
Optimer Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 travelers diarrhea
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None