Clinical Study “Spontaneous Bowel Movement Frequency”
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Efficacy “Japanese Phase 3 Study”6,29
[Primary endpoint (confirmatory analysis item)]
Changes in spontaneous bowel movement frequency 〔Week 2 of the observation period vs. Week 1 of the treatment period〕 (FAS)
Changes (mean ± SD) in spontaneous bowel movement (SBM) frequency from Week 2 of the observation period to Week 1 of the treatment period was 1.73 ± 1.88 times in the placebo group and 6.40 ± 4.73 times in the GOOFICE® group. The change in the spontaneous bowel movement frequency was significantly larger in the GOOFICE® group than in the placebo group, and superiority was verified (p < 0.0001, analysis of covariance).
Change in SBM frequency
Observation period 2nd week vs. Administration period 1st week
SBM frequency (Week 2 of the observation period and Week 1 of the treatment period)
[Secondary endpoints]
Changes in spontaneous bowel movement frequency〔Week 2 of the observation period vs. Week 2 of the treatment period〕(FAS)
Changes (mean ± SD) in spontaneous bowel movement frequency from Week 2 of the observation period to Week 2 of the treatment period were 1.79 ± 1.78 times in the placebo group and 5.00 ± 3.20 times in the GOOFICE® group. The changes in the spontaneous bowel movement frequency in the GOOFICE® group showed significant increases as compared with the placebo group (p < 0.0001, analysis of covariance).
Observation period 2nd week vs. Administration period 2nd week
SBM frequency (Week 2 of the observation period and Week 2 of the treatment period)
Efficacy “Japanese Long-term Administration Study”7,29
Changes from Week 2 of the observation period and time course of bowel movement frequency (spontaneous bowel movement/complete spontaneous bowel movement)
A comparative test was conducted to examine the changes in the spontaneous bowel movement frequency and the complete spontaneous bowel movement frequency between Week 2 of the observation period and Weeks 4, 12, 24, 36, and 52 of the treatment period. At all time points, significant increases were observed as compared with Week 2 of the observation period (p < 0.0001 for all, one-sample t-test).
The spontaneous bowel movement frequency and the complete spontaneous bowel movement frequency per week increased from Week 1 of the treatment period and remained as follows up to Week 52.
Amount of changes of SBM frequency from the 2nd week of observation period
Amount of change of CSBM frequency from the 2nd week of observation period
Changes in SBM Frequency and CSBM Frequency
