Patients of chronic constipation without defecation desire will be orally administered elobixibat 10 mg once daily before meals for 4 weeks. The primary endpoint of the pre/post comparative study will be the percentage of improvement in bowel movements from Week 2 of the observation period at Week 4 of the treatment period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Patients of chronic constipation with loss of defecation desire are administered Elobixibat 10mg for 4 weeks
Yokohama City University
Yokohama, Kanagawa, Japan
RECRUITINGPercentage of change in loss of defecation desire
Percentage of change in loss of defecation desire in the fourth week of the treatment period from the second week of the observation period (patient questionnaire). The presence or absence of defecation desire was assessed using a 5-point scale on the patient questionnaire: 1. always, 2. almost always, 3. a little, 4. almost never, 5. never.
Time frame: Week 4
Presence of defecation desire
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire). The presence or absence of defecation desire was assessed using a 5-point scale on the patient questionnaire: 1. always, 2. almost always, 3. a little, 4. almost never, 5. never.
Time frame: Week 4
Satisfaction with defecation desire
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Time frame: Week 4
Satisfaction of straining
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period(patient questionnaire).
Time frame: Week 4
Degree of straining
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period(patient questionnaire).
Time frame: Week 4
Presence of a sense of incomplete evacuation
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
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Time frame: Week 4
Satisfaction with treatment
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Time frame: Week 4
Spontaneous bowel movement (SBM) frequency
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient daily).
Time frame: Week 4
Complete Spontaneous Bowel Movement (CSBM) frequency
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient daily).
Time frame: Week 4
Stool hardness based on the Bristol Stool Form Scale
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Time frame: Week 4
Constipation severity score
Comparison of the Constipation severity score at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Time frame: Week 4
Japanese version of the Patient Assessment of Constipation Quality of Life
Comparison of the Japanese version of the Patient Assessment of Constipation Quality of Life questionrair at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Time frame: Week 4
Change of bile acid cocentration
Comparison of the bile acid concentration at Week 4 of the treatment period with Week 2 of the observation period (serum and feces).
Time frame: Week 4
Change in defecation time.
Changes in the time from taking elobixibat to defecation each week during the treatment period
Time frame: Week 4