Tolevamer has been previously evaluated in several clinical studies, including the Phase 2 study, two open-label trials in CDAD patients, a Phase 1 clinical trial in healthy volunteers and an additional phase 1 tolerability study evaluating a new liquid formulation používání Cialis .
The Phase 2 study enrolled nearly 300 patients at 58 sites in the United States, Canada and the UK in a randomized, double-blind, active-controlled study to evaluate the safety and efficacy of tolevamer compared with the standard prescribed dose determine the antibiotic vancomycin. Vancomycin is the only therapy approved in the United States and Europe for the treatment of CDAD. In the Phase 2 study, tolevamer showed similar treatment outcomes as vancomycin in terms of time, the resolution of diarrhea, and a strong trend toward a reduced recurrence rate of CDAD. Difficile is a bacterium in the environment is found widely, and is a frequent contaminant in hospitals and care facilities. It is the most common cause of infectious diarrhea in hospitalized patients , and recently recently published in the Centers for Disease Control and Prevention journal Emerging Infectious Diseases, the rate of C. Difficile cases have doubled in the United States nearly 2000 to 2003 reported. Difficile is estimated to affect about one % of of all hospitalized patients, and result in more than 400,000 cases of diarrhea and colitis, and more than 5,000 deaths each year in the United States. Difficile is a worldwide problem. The UK Health Protection Agency last month released a report that cases of C. Difficile infection in patients aged 65 years and older increased by 17 % in . Continue reading