Overall Study Design and Plan-Description Clause Samples
Overall Study Design and Plan-Description. This is a controlled, open-label, parallel-group study evaluating the efficacy and safety of Racecadotril in infants, children and adolescents with acute diarrhea. The number of subjects to be screened is 150 in order to enroll 124 subjects for either standard treatment (oral rehydration solution, ORS) alone or ORS plus Racecadotril.
Overall Study Design and Plan-Description. This is a prospective, open-label, multicenter, single-arm study evaluating the efficacy and safety of Racecadotril in infants and children with acute diarrhea in out-patients. The number of subjects to be screened is 50 in order to achieve 40 subjects treated with standard treatment (oral rehydration solution, ORS) plus Racecadotril.