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August 5, 2002
Results of a phase II trial of URSO 250 for the prevention of the recurrence of colorectal adenomatous polyps showed no statistically significant differences between the URSO 250 group and the placebo group. 594 subjects who had undergone the removal of a colorectal adenoma or a localized early stage cancerous tumor were given URSO 250 or placebo for a treatment period of one year. At a one-year follow-up, the number, size and histology of colorectal polyps were recorded. In the overall study population, there was no statistically significant difference in mean number of recurring polyps between the URSO 250 and placebo groups. However, says Axcan Pharma, in a sub-group of subjects with early stage colorectal cancer, there was a confirmed trend showing a 26% reduction of polyp recurrence rate in the URSO 250 group.