The objective of this study is to investigate dose-responses of efficacy and safety of ASP0456 in patients with chronic constipation (diagnosed by Rome III criteria of functional constipation (FC), not including constipation due to organic diseases) compared to placebo and to find the appropriate dose for P3 study.
To determine optimum dose of ASP0456 for the patients with chronic constipation (not including constipation due to organic diseases) in Japan based on its efficacy and safety, multicentered, placebo-controlled, double-blind, parallel group comparative study will be conducted. After two-week observation period, the patient who meets the primary registration criteria will be randomized to the one from five groups and will start treatment period. The patients will take once daily orally before the breakfast for two weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
383
Change in weekly average of SBM frequency
SBM: Spontaneous Bowel Movement. SBM means the defecation without procedure of laxative, suppository, enema, or stool extraction on the day or preceding day of the defecation. SBM frequency is calculated as follows: (the week total number of SBM )/ (the total number of days on which the frequency of SBM is evaluable) x7
Time frame: From baseline to week 1
Weekly responder rate for SBM
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
Time frame: up to 2 weeks
Weekly responder rate for CSBM
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
Time frame: up to 2 weeks
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.
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
Time frame: up to 2 weeks
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Site: 35
Aichi, Japan
Site: 36
Aichi, Japan
Site: 27
Chiba, Japan
Site: 28
Chiba, Japan
Site: 29
Chiba, Japan
Site: 30
Chiba, Japan
Site: 48
Fukuoka, Japan
Site: 49
Fukuoka, Japan
Site: 50
Fukuoka, Japan
Site: 1
Hokkaido, Japan
...and 40 more locations
Weekly responder rate of the abdominal bowel habits improvement in chronic constipation.
Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2
Time frame: up to 2 weeks
Weekly responder rate of abdominal symptom relief of chronic constipation.
Score of abdominal symptom improvement effect (7 scores: 1-7) is 1 or 2
Time frame: up to 2 weeks
Score of the global assessment of relief of chronic constipation
Scores will be measured using a seven-point ordinal score
Time frame: up to 2 weeks
Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)
IBS-QOL-J: Irritable bowel syndrome quality of life Japanese version
Time frame: Week 0, and 2
Changes in weekly average of SBM frequency
SBM: Spontaneous Bowel Movement
Time frame: From baseline to every week until 2 weeks
Changes in weekly average of CSBM frequency
CSBM: Complete Spontaneous Bowel Movement
Time frame: From baseline to every week until 2 weeks
Changes in weekly average of stool form
Stool form will be measured using seven-point Bristol Stool Form Scale
Time frame: From baseline to every week until 2 weeks
Changes in weekly average of abdominal bloating severity scores
Abdominal bloating severity will be measured using a five-point ordinal score
Time frame: From baseline to every week until 2 weeks
Changes in weekly average of abdominal pain/discomfort severity scores
Abdominal pain/discomfort severity will be measured using a five-point ordinal score
Time frame: From baseline to every week until 2 weeks
Changes in weekly average of straining severity scores
Straining severity will be measured using a five-point ordinal score
Time frame: From baseline to every week until 2 weeks
Score of the abdominal bowel habits improvement in chronic constipation
Scores will be measured using a seven-point ordinal score
Time frame: up to 2 weeks
Score of the abdominal symptom relief of chronic constipation
Scores will be measured using a seven-point ordinal score
Time frame: up to 2 weeks
Safety assessed by development of incidence of adverse events, vital signs, clinical laboratory tests and body weight
Time frame: up to 2 weeks