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Time to Occurrence of First Spontaneous Bowel Movement

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Efficacy “Japanese Phase 3 Study6,29

[Secondary endpoints]
Time to the occurrence of first spontaneous bowel movement (FAS)

The median time to the occurrence of the first spontaneous bowel movement was 25.5 hours in the placebo group and 5.2 hours in the GOOFICE® group. The results of estimation by the Kaplan-Meier method and the log-rank test showed that the time to the occurrence of the first spontaneous bowel movement in the GOOFICE® group was significantly shorter than that in the placebo group (p = 0.0001).


<Secondary endpoint> Time before the first SBM
Two line graphs comparing the percentage of subjects experiencing spontaneous bowel movements (SBM) over time between placebo and Goofice® 10 mg groups. The left graph spans 0–48 hours, and the right graph spans 0–336 hours. In both graphs, the Goofice® group shows a faster and higher rate of SBM occurrence than the placebo group. A table below the graphs shows median time to first SBM: 25.5 hours for placebo (n=63) and 5.2 hours for Goofice® (n=69), with a statistically significant difference (p = 0.0001, log-rank test).

[Secondary endpoints]
Percentage of patients who had spontaneous bowel movement within 24 hours and 48 hours after the start of administration of the investigational product (FAS)

The percentage of patients with the occurrence of spontaneous bowel movement within 24 hours after the start of administration of the investigational product was 41.3% (26/63 patients) in the placebo group and 85.5% (59/69 patients) in the GOOFICE® group. The percentage of the patients with the occurrence of spontaneous bowel movement was significantly higher in the GOOFICE® group than in the placebo group (p < 0.0001 Fisher's exact test). The percentage of patients with the occurrence of spontaneous bowel movement within 48 hours after the start of administration of the investigational product was 69.8% (44/63 patients) in the placebo group and 92.8% (64/69 patients) in the GOOFICE® group. The percentage of the patients with the occurrence of spontaneous bowel movement was significantly higher in the GOOFICE® group than in the placebo group (p = 0.0012, Fisher's exact test).


  • Percentage of patients who experienced SBM
    within 24 hours after the start of the
    investigational product

    Bar graph comparing the percentage of patients who experienced spontaneous bowel movement (SBM) within 24 hours after starting treatment. The y-axis shows percentage (0–100%), and the x-axis shows two groups: Placebo (41.3%, n=63) and Goofice® 10 mg (85.5%, n=69). The Goofice® group had a significantly higher SBM rate within 24 hours (p < 0.0001, Fisher's exact test).


  • Percentage of patients who experienced SBM
    within 48 hours after the start the
    investigational product

    Bar graph comparing the percentage of patients who experienced spontaneous bowel movement (SBM) within 48 hours after starting treatment. The y-axis shows percentage (0–100%), and the x-axis shows two groups: Placebo (69.8%, n=63) and Goofice® 10 mg (92.8%, n=69). The Goofice® group had a significantly higher SBM rate within 48 hours (p = 0.0012, Fisher's exact test).
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.）

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