Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
- Conditions
- Irritable Bowel Syndrome With Constipation (IBS-C)
- Interventions
- Drug: Placebo
- Registration Number
- NCT02316899
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The objective of this study is to evaluate the efficacy and safety of ASP0456 in patients with constipation predominant irritable bowel syndrome (IBS-C).
- Detailed Description
\<Period I (double-blind period)\> A multicenter, collaborative, double-blind, parallel comparative study is conducted using IBS-C patients as subjects to verify efficacy of ASP0456 and examine the safety. After the 2-week bowel habit observation period, subjects satisfying the primary enrollment criteria are randomly allocated to either ASP0456 group or placebo group, and orally administered the drug or placebo once daily before breakfast for 12 weeks.
\<Period II (non-blind period)\> A multicenter, collaborative, non-blind, non-controlled study is conducted to examine safety and efficacy of ASP0456 in long-term administration in IBS-C patients. After Period I, subjects satisfying the transfer criteria are orally administered ASP0456 once daily before breakfast for 40 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- Patients who had abdominal pain or discomfort repeatedly for at least 3 days per month during the 3 months before screening examination associated with at least 2 out of the following 3 conditions: (1) Improvement with defecation; (2) Onset associated with a change in frequency of stool; and (3) Onset associated with a change in form (appearance) of stool, and had the above symptom (IBS symptom) 6 months or more before the screening examination period
- Patients with ≥ 25% of stools hard or lumpy (with each bowel movement occurring without antidiarrheal, laxative, suppository or enema) and <25% of them loose (mushy) or watery during the 3 months before the screening examination
- Patients who had pancolonoscopy or contrast enema (or sigmoidoscopy) after the onset of IBS symptom and had no organic changes
- Patient with history of surgical resection of stomach, gallbladder, small intestine, or large intestine (excluding resection of appendicitis and benign polyp)
- Patient with history or current affection of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Patient with history or current affection of ischemic colitis
- Patient currently affected by infectious enteritis
- Patient currently affected by hyperthyroidism or hypothyroidism
- Patient currently affected by active peptic ulcer
- In the case of a female patient, the one currently affected by endometriosis or uterine adenomyosis
- Patient with high depression or anxiety considered to influence drug evaluation
- Patient with history of abuse of drug or alcohol within a year before consent acquisition, or with current abuse
- Patient who used or underwent or will use or undergo drug/therapy/test prohibited to combine 3 days before the start of bowel habit observation period (Day -17) or thereafter
- Patient with history or current affection of malignant tumor
- Patient currently affected by serious cardiovascular disease, respiratory disease, kidney disease, hepatic disease, gastrointestinal disease (excluding IBS), hemorrhagic disease, or neural/mental disease
- Patient with history of drug allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (Period I) Placebo Up to 12 weeks ASP0456 (Period II) linaclotide From 12 weeks to 52 weeks ASP0456 (Period I) linaclotide Up to 12 weeks
- Primary Outcome Measures
Name Time Method Responder rate of Global assessment of relief of IBS symptoms during 12 weeks. During 12 weeks The responder of the evaluation items during the 12 weeks shall be the subject satisfying weekly responder of the evaluation items for over 6 weeks of the 12 weeks.
Responder rate of CSBM during 12 weeks During 12 weeks CSBM: Complete Spontaneous Bowel Movement. The responder of the evaluation items during the 12 weeks shall be the subject satisfying weekly responder of the evaluation items for over 6 weeks of the 12 weeks.
- Secondary Outcome Measures
Name Time Method Responder rate of SBM during 12 weeks During 12 weeks SBM: Spontaneous Bowel Movement
Responder rate of Abnormal bowel habits improvement during 12 weeks During 12 weeks Responder rate of Abdominal pain/discomfort relief during 12 weeks During 12 weeks Weekly responder rate of Global assessment of relief of IBS symptoms Up to 52 weeks The weekly responder of the evaluation items shall be the subject satisfying the followings at the time of evaluation in each week.Score of Global assessment of relief of IBS symptoms (7 scores: 1-7) is 1 or 2
Weekly responder rate of CSBM Up to 52 weeks Weekly responder of CSBM: The weekly mean 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
Weekly responder rate of SBM Up to 52 weeks Weekly responder of SBM: The weekly mean 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 of Abnormal bowel habits improvement Up to 52 weeks Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2
Weekly responder rate of Abdominal pain/discomfort relief Up to 52 weeks Score of abdominal pain/discomfort improvement effect (7 scores: 1-7) is 1 or 2.
Changes in weekly average of SBM frequency, CSBM frequency, stool form scores, abdominal pain/discomfort severity, abdominal bloating severity, and straining severity. From baseline to every week until 52 weeks Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales) Weeks 0, 4, 8, 12, 16, 20, 24, 28, 40, 52 IBS-QOL-J: Irritable bowel syndrome quality of life Japanese version
Percentage of subjects with SBM within 24 hours after start of the initial administration Up to 24 hours Percentage of subjects with CSBM within 24 hours after start of the initial administration Up to 24 hours Safety assessed by development of incidence of adverse events, vital signs, and clinical laboratory tests Up to 52 weeks
Trial Locations
- Locations (61)
Site JP00001
🇯🇵Hokkaido, Japan
Site JP00048
🇯🇵Aichi, Japan
Site JP00038
🇯🇵Chiba, Japan
Site JP00040
🇯🇵Chiba, Japan
Site JP00039
🇯🇵Chiba, Japan
Site JP00042
🇯🇵Chiba, Japan
Site JP00041
🇯🇵Chiba, Japan
Site JP00002
🇯🇵Fukuoka, Japan
Site JP00006
🇯🇵Hokkaido, Japan
Site JP00061
🇯🇵Fukuoka, Japan
Site JP00007
🇯🇵Hokkaido, Japan
Site JP00058
🇯🇵Hyogo, Japan
Site JP00057
🇯🇵Hyogo, Japan
Site JP00030
🇯🇵Kanagawa, Japan
Site JP00032
🇯🇵Kanagawa, Japan
Site JP00034
🇯🇵Kanagawa, Japan
Site JP00035
🇯🇵Kanagawa, Japan
Site JP00036
🇯🇵Kanagawa, Japan
Site JP00037
🇯🇵Kanagawa, Japan
Site JP00056
🇯🇵Kyoto, Japan
Site JP00050
🇯🇵Osaka, Japan
Site JP00053
🇯🇵Osaka, Japan
Site JP00054
🇯🇵Osaka, Japan
Site JP00043
🇯🇵Saitama, Japan
Site JP00055
🇯🇵Osaka, Japan
Site JP00045
🇯🇵Saitama, Japan
Site JP00044
🇯🇵Saitama, Japan
Site JP00046
🇯🇵Saitama, Japan
Site JP00047
🇯🇵Saitama, Japan
Site JP00005
🇯🇵Tokyo, Japan
Site JP00009
🇯🇵Tokyo, Japan
Site JP00008
🇯🇵Tokyo, Japan
Site JP00011
🇯🇵Tokyo, Japan
Site JP00010
🇯🇵Tokyo, Japan
Site JP00012
🇯🇵Tokyo, Japan
Site JP00013
🇯🇵Tokyo, Japan
Site JP00014
🇯🇵Tokyo, Japan
Site JP00016
🇯🇵Tokyo, Japan
Site JP00017
🇯🇵Tokyo, Japan
Site JP00023
🇯🇵Tokyo, Japan
Site JP00026
🇯🇵Tokyo, Japan
Site JP00027
🇯🇵Tokyo, Japan
Site JP00029
🇯🇵Tokyo, Japan
Site JP00060
🇯🇵Fukuoka, Japan
Site JP00024
🇯🇵Tokyo, Japan
Site JP00059
🇯🇵Hyogo, Japan
Site JP00004
🇯🇵Aichi, Japan
Site JP00015
🇯🇵Tokyo, Japan
Site JP00018
🇯🇵Tokyo, Japan
Site JP00031
🇯🇵Kanagawa, Japan
Site JP00003
🇯🇵Osaka, Japan
Site JP00052
🇯🇵Osaka, Japan
Site JP00049
🇯🇵Aichi, Japan
Site JP00025
🇯🇵Tokyo, Japan
Site JP00033
🇯🇵Kanagawa, Japan
Site JP00051
🇯🇵Osaka, Japan
Site JP00019
🇯🇵Tokyo, Japan
Site JP00020
🇯🇵Tokyo, Japan
Site JP00021
🇯🇵Tokyo, Japan
Site JP00022
🇯🇵Tokyo, Japan
Site JP00028
🇯🇵Tokyo, Japan