Evaluation of Stool Hardness and Severity of Constipation
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Efficacy “Japanese Phase 3 Study”6,29
[Secondary endpoints]
Stool hardness based on Bristol Stool Form Scale (FAS)
The median (mean ± SD) weekly score of the Bristol Stool Form Scale was 2.1 ± 1.2 in the placebo group and 2.4 ± 1.1 in the GOOFICE® group at Week 2 of the observation period, 2.5 ± 1.2 in the placebo group and 4.4 ± 1.3 in the GOOFICE® group at Week 1 of the treatment period, and 2.7 ± 1.4 in the placebo group and 4.2 ± 1.2 in the GOOFICE® group at Week 2 of the treatment period. At both Week 1 and Week 2 of the treatment period, the median stool hardness based on the Bristol Stool Form Scale in the GOOFICE® group was significantly higher than in the placebo group (p < 0.0001 at both Week 1 and Week 2 of the treatment period, Wilcoxon rank sum test).
<Secondary endpoint> Stool consistency as measured using the Bristol Stool Form Scale
[Secondary endpoints]
Evaluation of severity of constipation (FAS)
The severity of constipation (mean ± SD) was 2.7 ± 0.8 in the placebo group and 2.7 ± 0.8 in the GOOFICE® group at Week 2 of the observation period, 2.3 ± 1.0 in the placebo group and 1.1 ± 1.1 in the GOOFICE® group at Week 1 of the treatment period, and 2.1 ± 1.1 in the placebo group and 1.0 ± 1.0 in the GOOFICE® group at Week 2 of the treatment period. At both Week 1 and Week 2 of the treatment period, severity of constipation was evaluated as significantly lower in the GOOFICE® group than in the placebo group (p < 0.0001 at both Week 1 and Week 2 of the treatment period, Wilcoxon rank sum test).
<Secondary endpoint> Severity of constipation
