@entity4480 vs placebo in the treatment of XXXX : a four-continent randomized clinical trial.

@entity1 @entity322 @entity390 @entity4480 @entity3142
OBJECTIVES: To further assess, in a phase 3 study, treatment with @entity4480 for @entity1 with @entity3142 ( @entity3142 ) in other geographical regions, including Argentina, Australia, Brazil, Finland, Poland, South Africa and Spain, as previous trials in North America and Europe provided evidence for the safety and efficacy of @entity4480 as a pharmacological treatment for @entity3142 in @entity1 . @entity1 AND METHODS: The study included 458 @entity1 aged 27-79 years enrolled in a double-blind, placebo-controlled trial. The @entity1 with predominantly @entity3142 were identified using a validated clinical algorithm. They were randomly assigned to receive placebo (231) or @entity4480 40 mg twice daily (227) for 12 weeks. The primary outcome variables included the @entity322 ( @entity322 ) and the Incontinence Quality of Life (I-QOL) questionnaire. Van Elteren's test was used to analyse the percentage changes in @entity322 where the stratification variable was weekly baseline @entity322 ( @entity322 < 14 and > or = 14). Analysis of covariance was used to analyse I-QOL scores. RESULTS: The mean baseline @entity322 was 18.4/week; 55% of @entity1 had a baseline @entity322 of > or = 14. There was a significantly greater median decrease in @entity322 with @entity4480 with placebo (54% vs 40%, P = 0.05), with comparable significant improvements in quality of life (I-QOL score increases of 10.3 vs 6.4, P = 0.007). The improvements with @entity4480 were associated with significantly greater increases in voiding intervals than with placebo (20.4 vs 8.5 min, P < 0.001). The placebo response was 10.7% and 12.5% higher than those reported in two European and North American phase 3 trials. This may have been related to more @entity1 being na  ve for @entity322 management in the current trial. Discontinuation rates for adverse events were 1.7% for placebo and 17.2% for @entity4480 (P < 0.001), with @entity390 being the most common reason for discontinuation (3.1%); it was the most common adverse event with @entity4480 , but was mild or moderate in most (81%), did not worsen in any @entity1 and resolved within 7 days in 60% and within 1 month in 86% of continuing @entity1 ; 88% of @entity1 who experienced @entity390 while taking @entity4480 completed the trial. CONCLUSIONS: These results show improvements in @entity322 and quality of life with @entity4480 40 mg twice daily for 12 weeks that are in keeping with those reported in two other recently completed phase 3 trials in Europe and North America.
