Weekly responder rate for SBM
Time frame · up to 2 weeks
Registry description
The weekly average value of SBM frequency is more than 3 and over 1 more than the weekly mean value of SBM frequency in the bowel habit observation period
Weekly responder rate for CSBM
Time frame · up to 2 weeks
Registry description
The weekly average value of CSBM frequency is more than 3 and over 1 more than the weekly mean value of CSBM frequency in the bowel habit observation period
Percentage of subjects with SBM within 24 hours after the start of initial treatment
Time frame · up to 24 hours
Change in weekly average of CSBM frequency
Time frame · From baseline to week 1
Proportion of subjects with CSBM within 24 hours after the start of initial treatment
Time frame · up to 24 hours
Weekly responder rate of the global assessment of relief of chronic constipation.
Time frame · up to 2 weeks
Registry description
The weekly responder of the evaluation items shall be the subject satisfying the following at the time of evaluation in each week: Score of Global assessment of relief of chronic constipation symptoms (7 scores: 1-7) is 1 or 2
Weekly responder rate of the abdominal bowel habits improvement in chronic constipation.
Time frame · up to 2 weeks
Registry description
Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2
Weekly responder rate of abdominal symptom relief of chronic constipation.
Time frame · up to 2 weeks
Registry description
Score of abdominal symptom improvement effect (7 scores: 1-7) is 1 or 2
Score of the global assessment of relief of chronic constipation
Time frame · up to 2 weeks
Registry description
Scores will be measured using a seven-point ordinal score
Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)
Time frame · Week 0, and 2
Registry description
IBS-QOL-J: Irritable bowel syndrome quality of life Japanese version
Changes in weekly average of SBM frequency
Time frame · From baseline to every week until 2 weeks
Registry description
SBM: Spontaneous Bowel Movement
Changes in weekly average of CSBM frequency
Time frame · From baseline to every week until 2 weeks
Registry description
CSBM: Complete Spontaneous Bowel Movement
Changes in weekly average of stool form
Time frame · From baseline to every week until 2 weeks
Registry description
Stool form will be measured using seven-point Bristol Stool Form Scale
Changes in weekly average of abdominal bloating severity scores
Time frame · From baseline to every week until 2 weeks
Registry description
Abdominal bloating severity will be measured using a five-point ordinal score
Changes in weekly average of abdominal pain/discomfort severity scores
Time frame · From baseline to every week until 2 weeks
Registry description
Abdominal pain/discomfort severity will be measured using a five-point ordinal score
Changes in weekly average of straining severity scores
Time frame · From baseline to every week until 2 weeks
Registry description
Straining severity will be measured using a five-point ordinal score
Score of the abdominal bowel habits improvement in chronic constipation
Time frame · up to 2 weeks
Registry description
Scores will be measured using a seven-point ordinal score
Score of the abdominal symptom relief of chronic constipation
Time frame · up to 2 weeks
Registry description
Scores will be measured using a seven-point ordinal score
Safety assessed by development of incidence of adverse events, vital signs, clinical laboratory tests and body weight
Time frame · up to 2 weeks