Irritable Bowel Syndrome With Constipation (IBS-C) Clinical Trial
Official title:
Phase III Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study and Long-term Study in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Verified date | December 2019 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate the efficacy and safety of ASP0456 in patients with constipation predominant irritable bowel syndrome (IBS-C).
Status | Completed |
Enrollment | 500 |
Est. completion date | March 29, 2016 |
Est. primary completion date | September 19, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 79 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Japan | Site JP00004 | Aichi | |
Japan | Site JP00048 | Aichi | |
Japan | Site JP00049 | Aichi | |
Japan | Site JP00038 | Chiba | |
Japan | Site JP00039 | Chiba | |
Japan | Site JP00040 | Chiba | |
Japan | Site JP00041 | Chiba | |
Japan | Site JP00042 | Chiba | |
Japan | Site JP00002 | Fukuoka | |
Japan | Site JP00060 | Fukuoka | |
Japan | Site JP00061 | Fukuoka | |
Japan | Site JP00001 | Hokkaido | |
Japan | Site JP00006 | Hokkaido | |
Japan | Site JP00007 | Hokkaido | |
Japan | Site JP00057 | Hyogo | |
Japan | Site JP00058 | Hyogo | |
Japan | Site JP00059 | Hyogo | |
Japan | Site JP00030 | Kanagawa | |
Japan | Site JP00031 | Kanagawa | |
Japan | Site JP00032 | Kanagawa | |
Japan | Site JP00033 | Kanagawa | |
Japan | Site JP00034 | Kanagawa | |
Japan | Site JP00035 | Kanagawa | |
Japan | Site JP00036 | Kanagawa | |
Japan | Site JP00037 | Kanagawa | |
Japan | Site JP00056 | Kyoto | |
Japan | Site JP00003 | Osaka | |
Japan | Site JP00050 | Osaka | |
Japan | Site JP00051 | Osaka | |
Japan | Site JP00052 | Osaka | |
Japan | Site JP00053 | Osaka | |
Japan | Site JP00054 | Osaka | |
Japan | Site JP00055 | Osaka | |
Japan | Site JP00043 | Saitama | |
Japan | Site JP00044 | Saitama | |
Japan | Site JP00045 | Saitama | |
Japan | Site JP00046 | Saitama | |
Japan | Site JP00047 | Saitama | |
Japan | Site JP00005 | Tokyo | |
Japan | Site JP00008 | Tokyo | |
Japan | Site JP00009 | Tokyo | |
Japan | Site JP00010 | Tokyo | |
Japan | Site JP00011 | Tokyo | |
Japan | Site JP00012 | Tokyo | |
Japan | Site JP00013 | Tokyo | |
Japan | Site JP00014 | Tokyo | |
Japan | Site JP00015 | Tokyo | |
Japan | Site JP00016 | Tokyo | |
Japan | Site JP00017 | Tokyo | |
Japan | Site JP00018 | Tokyo | |
Japan | Site JP00019 | Tokyo | |
Japan | Site JP00020 | Tokyo | |
Japan | Site JP00021 | Tokyo | |
Japan | Site JP00022 | Tokyo | |
Japan | Site JP00023 | Tokyo | |
Japan | Site JP00024 | Tokyo | |
Japan | Site JP00025 | Tokyo | |
Japan | Site JP00026 | Tokyo | |
Japan | Site JP00027 | Tokyo | |
Japan | Site JP00028 | Tokyo | |
Japan | Site JP00029 | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Responder rate of Global assessment of relief of IBS symptoms 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. | During 12 weeks | |
Primary | Responder rate of CSBM 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. | During 12 weeks | |
Secondary | Responder rate of SBM during 12 weeks | SBM: Spontaneous Bowel Movement | During 12 weeks | |
Secondary | Responder rate of Abnormal bowel habits improvement during 12 weeks | During 12 weeks | ||
Secondary | Responder rate of Abdominal pain/discomfort relief during 12 weeks | During 12 weeks | ||
Secondary | Weekly responder rate of Global assessment of relief of IBS symptoms | 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 | Up to 52 weeks | |
Secondary | Weekly responder rate of CSBM | 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 | Up to 52 weeks | |
Secondary | Weekly responder rate of SBM | 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 | Up to 52 weeks | |
Secondary | Weekly responder rate of Abnormal bowel habits improvement | Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2 | Up to 52 weeks | |
Secondary | Weekly responder rate of Abdominal pain/discomfort relief | Score of abdominal pain/discomfort improvement effect (7 scores: 1-7) is 1 or 2. | Up to 52 weeks | |
Secondary | 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 | ||
Secondary | 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 | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 40, 52 | |
Secondary | Percentage of subjects with SBM within 24 hours after start of the initial administration | Up to 24 hours | ||
Secondary | Percentage of subjects with CSBM within 24 hours after start of the initial administration | Up to 24 hours | ||
Secondary | Safety assessed by development of incidence of adverse events, vital signs, and clinical laboratory tests | Up to 52 weeks |
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