This multi-center, double-blind, randomized and placebo-controlled clinical trial compares the safety and efficacy of Prulifloxacin versus placebo in adult travelers suffering from acute bacterial gastroenteritis.
Clinical trial sites included locations in India, Guatemala, and Mexico. The primary endpoint is time to last unformed stool (TLUS) and secondary endpoints include clinical cure based on relief of symptoms and microbiological eradication rates.
The company previously reported positive top-line data from the first Phase III trial which showed that Prulifloxacin met the primary endpoint of TLUS, a measure of the time to resolution of diarrhea, compared to placebo with a p-value of <0.0001. If the results of this second study are also positive, the company expects to use these studies as a basis for a new drug application filing in 2009. Michael Chang, CEO and president of Optimer, said: "We look forward to completing the analysis of the data from this trial and we expect top-line results in the fourth quarter."