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, randomized, double-blind, multicenter study assessing the effectiveness of 20 mg and 40 mg of Aciphex QD versus placebo for healing endoscopically defined duodenal ulcers, 100 patients were treated for up to four weeks. Mean reductions from baseline in daily antacid dose were statistically significant for all Aciphex groups when compared to placebo at both Weeks 4 and 8 (p≤0. All Aciphex groups reported significantly greater rates of complete resolution of GERD daytime heartburn severity compared to placebo at Weeks 4 and 8 (p≤0. The median inhibitory effect of Aciphex on 24 hour gastric acidity is 88% of maximal after the first dose. The study was designed to provide at least 80% power to exclude a difference of at least 10% between Aciphex and omeprazole, assuming four-week healing response rates of 93% for both groups.
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