EA Pharma Co., Ltd. logo linking to the homepage, displayed at the top left corner of all website pages for medical professional

Eisai Group logo displayed at the top right corner of all pages on the EA Pharma's website
日本語ページ

Complete Spontaneous Bowel Movement Frequency

For information on warnings, contraindications, and precautions, please refer to the "Drug information" page in the package insert.

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)
Bar chart comparing changes in Complete Spontaneous Bowel Movement (CSBM) frequencies between placebo and Elobixibat 10 mg groups during the 1st and 2nd weeks of the administration period, relative to the 2nd week of the observation period. In Week 1, the placebo group (n=63) shows a mean change of 0.62/week, while the Elobixibat group (n=67) shows a significant increase to 3.39/week (p<0.0001). In Week 2, the placebo group (n=63) shows a change of 0.86/week, and the Elobixibat group (n=65) increases to 2.98/week (p<0.0001). Data are presented as mean ± SD and analyzed using ANCOVA with baseline CSBM frequency as covariate.

CSBM frequency (Week 2 of the observation period, Weeks 1 and 2 of the administration period)
Bar chart showing Complete Spontaneous Bowel Movement (CSBM) frequency in times per week for placebo and Goofice® 10 mg groups across three timepoints: Week 2 of the observation period, Week 1 of the administration period, and Week 2 of the administration period. In the observation period, CSBM frequency was 0.48/week (placebo, n=63) and 0.55/week (Goofice®, n=69). In Week 1 of administration, frequencies increased to 1.10/week (placebo, n=63) and 3.96/week (Goofice®, n=67). In Week 2, frequencies were 1.33/week (placebo, n=63) and 3.57/week (Goofice®, n=65). Error bars indicate mean ± SD.
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
Line graph showing changes in spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM) frequency over a 52-week treatment period with Elobixibat in 340 participants. The x-axis spans weeks 1 to 52, and the y-axis shows frequency changes (0–10 times/week). Orange dots represent weekly mean values with error bars (Mean ± SD). Asterisks indicate statistically significant increases (p < 0.0001) compared to Week 2 of the observation period. Both SBM and CSBM frequencies increased from Week 1 and remained elevated through Week 52.

Amount of change of CSBM frequency from the 2nd week of observation period
Bar graph showing the amount of change in complete spontaneous bowel movement (CSBM) frequency from Week 2 of the observation period in 340 participants treated with Elobixibat. Each bar represents the mean change at specific time points during the 52-week treatment period, with error bars indicating standard deviation (Mean ± SD). Asterisks denote statistically significant increases (p < 0.0001) compared to Week 2 of the observation period, based on a one-sample t-test.

Changes in SBM Frequency and CSBM Frequency
Line graph showing changes in spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM) frequency over a 52-week treatment period in 340 participants receiving Goofice® 10 mg. The x-axis spans weeks 0 to 52, and the y-axis shows bowel movement frequency (0–10 times/week). The orange line represents SBM frequency and the brown line represents CSBM frequency. Both lines show an initial increase followed by sustained levels throughout the treatment period. Error bars indicate mean ± standard deviation.
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.）

This site uses cookies to provide better content, analyze access, and improve the convenience of the site. By continuing to browse this site, you agree to the use of cookies. For more information and to change cookie settings, please click here (PDF).

You are now leaving the EA Pharma website.

Thank you for browsing the EA Pharma website.
You are about to visit an external website.
(A new browsing window will be opened)

Click here to proceed

The Section is for Medical Professionals.

Terms of Use

The purpose of the section is to provide useful information to medical professionals (doctors, dentists, pharmacists, nurses, nutritionists, care workers, etc.) working in medical institutions.
Please note that the section is not intended to provide information to medical professionals outside of the approved countries, nor to the general public.

Doctor, Nurse, Pharmacist, Other Medical Professionals

If you are not a medical professional

Return to Top Page