In this double-blind comparative study, AJG533 (elobixibat) 10 mg or AJG533 placebo was orally administered once daily before meals for 12 weeks in patients with chronic constipation, and the primary endpoint was the change from Week 2 of the observation period in the number of complete spontaneous bowel movements (CSBM) at Week 12 of the treatment period. The primary endpoint was the change in the number of complete spontaneous bowel movements (CSBM) from Week 2 of the observation period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Patients with chronic constipation are administered Elobixibat 10mg for 12 weeks
Patients with chronic constipation are administered placebo for 12 weeks
Yokohama City University
Yokohama, Kanagawa, Japan
RECRUITINGChange in the number of complete spontaneous bowel movements at week 12
Change in the number of complete spontaneous bowel movements at week 12 of the treatment period from week 2 of the observation period. \*Spontaneous defecation without residual sensation.
Time frame: Week 12
Change in the number of complete spontaneous bowel movements in each week of the treatment period.
Change in the number of complete spontaneous bowel movements in each week of the treatment period.
Time frame: Each Week 1-11
Change in the number of spontaneous bowel movements in each week of the treatment.
Change in the number of spontaneous bowel movements in each week of the treatment.
Time frame: Each Week 1-11
Proportion of responders** in the number of SBMs during each week.
Proportion of responders\*\* in the number of spontaneous bowel movements (SBMs) during each week of the treatment period. \*\*In this study, we will investigate the effect of the treatment on the number of SBMs of a subject who has at least one more SBM per week than in the second week of the observation period, and at least three times per week.
Time frame: Each Week 1-11
Proportion of responders** in the number of CSBMs during each week.
Proportion of responders\*\* in the number of complete spontaneous a bowel movements (CSBMs) during each week of the treatment period. \*\*In this study, we will investigate the effect of the treatment on the number of CSBMs of a subject who has at least one more CSBMs per week than in the second week of the observation period, and at least three times per week.
Time frame: Each Week 1-11
The rate of a responder in the number of CSBM during the treatment period.
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Definition of Responder: Patients with 3 or more CSBM per week and 1 or more CSBM per week from baseline for 9 weeks out of the entire treatment period (12 weeks), including at least 3 weeks in the treatment period weeks 9 to 12.
Time frame: Week 12
Percent change in fecal hardness based on the Bristol Stool Quality Scale at each week.
Percent change in fecal hardness from week 2 of the observation period based on the Bristol Stool Quality Scale at each week of the treatment period. the minimum is 1 and maximum values, is 7.Higher scores mean a better outcome.
Time frame: Each Week 1-11
The percentage of change in the presence or absence of residual sensation at each week.
The percentage of change from week 2 of the observation period in the presence or absence of residual sensation at each week of the treatment period.
Time frame: Each Week 1-11
Percent change in the degree of twitching at each week.
Percent change from week 2 of the observation period in the degree of twitching at each week of the treatment period.
Time frame: Each Week 1-11
The percentage of change in the presence or absence of bowel movements at each week.
The percentage of change in the presence or absence of bowel movements at each week of the treatment period from week 2 of the observation period.
Time frame: Each Week 1-11
Change in Japanese Patient assessment of constipation quality of life score
Change in Japanese Patient assessment of constipation quality of life score at 4 and 12 weeks of the treatment period from the baseline (V2) of the study drug.the minimum is 0 and maximum values is 4.Lower scores mean a better outcome.
Time frame: Week 4, 12
The changes in occupancy rate of intestinal microbiota.
At 4 weeks and 12 weeks of the treatment period, the changes in occupancy rate of intestinal microbiota in feces from before the start of the study drug (V2) are examined.
Time frame: Week 4, 12
The change in absolute values rates in blood and fecal bile acids.
At 4 weeks and 12 weeks of the treatment period, the change in absolute values in blood and fecal bile acids from before the start of the study drug (V2) are examined.
Time frame: Week 4, 12
The change in absolute values for organic acids.
At 4 weeks and 12 weeks of the treatment period, the change in absolute values for organic acids in feces from before the start of the study drug (V2) are examined.
Time frame: Week 4, 12
The change in absolute values of amino acids in blood and feces.
At 4 weeks and 12 weeks of the treatment period, the change in absolute values of amino acids in blood and feces. from before the start of the study drug (V2) are examined.
Time frame: Week 4, 12
The change in amount blood C4.
At 4 weeks and 12 weeks of the treatment period, the change in amount blood C4 from before the start of the study drug (V2) are examined.
Time frame: Week 4, 12