DRUG
linaclotide
Oral administration once daily
Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
Status
Completed
Phase
Phase 3
Enrollment
500
Locations
61
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
The objective of this study is to evaluate the efficacy and safety of ASP0456 in patients with constipation predominant irritable bowel syndrome (IBS-C).
Full 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.
Interventions
Treatment arms and agents.
DRUG
Placebo
Oral administration once daily
Timeline
From registration to results.
First posted
Dec 15, 2014
Study start
Oct 21, 2014
Primary completion
Sep 19, 2015
Study completion
Mar 29, 2016
Results posted
Not reported
Registry updated
Oct 18, 2024
Outcomes
What the study measures.
Primary outcomes
Responder rate of Global assessment of relief of IBS symptoms during 12 weeks.
Time frame · 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
Time frame · 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 outcomes
Responder rate of SBM during 12 weeks
Time frame · During 12 weeks
SBM: Spontaneous Bowel Movement
Responder rate of Abnormal bowel habits improvement during 12 weeks
Time frame · During 12 weeks
Responder rate of Abdominal pain/discomfort relief during 12 weeks
Time frame · During 12 weeks
Weekly responder rate of Global assessment of relief of IBS symptoms
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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.
Time frame · From baseline to every week until 52 weeks
Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)
Time frame · Weeks 0, 4, 8, 12, 16, 20, 24, 28, 40, 52
IBS-QOL-J: Irritable bowel syndrome quality of life Japanese version
Eligibility
Who can take part.
- Minimum age
- 20 Years
- Maximum age
- 79 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
61 registered sites.
Japan. Showing up to 24 locations stored in the fast local snapshot.
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
Hyōgo, Japan
Site JP00058
Hyōgo, Japan
Site JP00059
Hyōgo, 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
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