Complete Spontaneous Bowel Movement Frequency

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Efficacy “Japanese Phase 3 Study”6,29

[Secondary endpoints]
Changes in complete spontaneous bowel movement frequency (Week 2 of the observation period vs. Weeks 1 and 2 of the treatment period) (FAS)

The change (mean ± SD) in the complete spontaneous bowel movement frequency from Week 2 of the observation period to Week 1 of the treatment period was 0.62 ± 1.44 times in the placebo group and 3.39 ± 3.86 times in the GOOFICE® group. The change in the complete spontaneous bowel movement frequency from Week 2 of the observation period to Week 2 of the treatment period was 0.86 ± 1.45 times in the placebo group and 2.98 ± 3.10 times in the GOOFICE® group. In the GOOFICE® group, the change in the complete spontaneous bowel movement frequency significantly increased as compared with the placebo group at both Week 1 and Week 2 of the treatment period (p < 0.0001 at both Week 1 and Week 2 of the treatment period, analysis of covariance).


Change in CSBM Frequencies
(Observation period 2nd week vs. Administration period 1st and 2nd weeks)
Change in CSBM Frequencies

CSBM frequency (Week 2 of the observation period, Weeks 1 and 2 of the administration period)
CSBM frequency (Week 2 of the observation period, Weeks 1 and 2 of the administration period)
6)EA Pharma Co., Ltd.: In-house data (investigation of efficacy and safety in patients with chronic constipation) <Data submitted for review for approval>
29)Nakajima A, et al.:Lancet Gastroenterol Hepatol 2018;3(8):537-547
(The authors include those who have received an advisory fee from EA Pharma Co., Ltd.
This study was supported by EA Pharma Co., Ltd. and Mochida Pharmaceutical Co., Ltd.)

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 changes of SBM frequency from the 2nd week of observation period

Amount of change of CSBM 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
Changes in SBM Frequency and CSBM Frequency
7)EA Pharma Co., Ltd.: In-house data (investigation of safety and efficacy of long-term administration in patients with chronic constipation) <Data submitted for review for approval>
29)Nakajima A, et al.:Lancet Gastroenterol Hepatol 2018;3(8):537-547
(The authors include those who have received an advisory fee from EA Pharma Co., Ltd.
This study was supported by EA Pharma Co., Ltd. and Mochida Pharmaceutical Co., Ltd.)

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