Constipation-predominant Irritable Bowel Syndrome (IBS-C)
Conditions
Keywords
irritable bowel syndrome (IBS), linaclotide, constipation, ASP0456
Brief summary
This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome.
Detailed description
This study is a multicenter, double-blind, placebo-controlled, parallel-group, comparative study to investigate dose-responses of efficacy, safety, and pharmacokinetics of ASP0456 in patients with constipation-predominant irritable bowel syndrome (IBS-C) according to the Rome III Diagnostic Criteria (2006 revised edition, established by the Rome III Committee) after oral administration of ASP0456.
Interventions
DRUGlinaclotide
oral
DRUGplacebo
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
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
* Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine * Patients with other concurrent diseases that may affect the digestive tract passage or large intestinal function * Patients with other concurrent diseases that may affect the assessment of abdominal pain/discomfort * Patients with blood pressure, pulse rate, clinical laboratory test, or 12-lead ECG at the time of screening examination that was rated as Grade 2 or greater on the Severity Criteria for Drug Adverse Reaction and judged to be clinically significant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global assessment of relief of IBS symptoms Responder | Weekly for 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessed by the incidence of adverse events, vital signs, clinical laboratory tests and 12-lead ECGs | for 12 weeks |
| SBM (Spontaneous Bowel Movement) Responder | Weekly for 12 weeks |
| CSBM (Complete SBM) Responder | Weekly for 12 weeks |
| Abnormal bowel habits improvement Responder | Weekly for 12 weeks |
| Abdominal pain/discomfort relief Responder | Weekly for 12 weeks |
| Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales) | Weekly for 12 weeks |
| Changes in weekly average of CSBM frequency | Weekly for 12 weeks |
| Changes in weekly average of stool form scores | Weekly for 12 weeks |
| Changes in weekly average of abdominal pain/discomfort severity | Weekly for 12 weeks |
| Changes in weekly average of straining severity | Weekly for 12 weeks |
| Changes in weekly average of SBM frequency | Weekly for 12 weeks |
Countries
Japan
Outcome results
None listed