Constipation-predominant Irritable Bowel Syndrome (IBS-C) Clinical Trial
Official title:
Phase II Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study in Patients With Constipation-predominant Irritable Bowel Syndrome
| Verified date | January 2020 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome.
| Status | Completed |
| Enrollment | 559 |
| Est. completion date | December 7, 2013 |
| Est. primary completion date | December 7, 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 64 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: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Global assessment of relief of IBS symptoms Responder | Weekly for 12 weeks | ||
| Secondary | SBM (Spontaneous Bowel Movement) Responder | Weekly for 12 weeks | ||
| Secondary | CSBM (Complete SBM) Responder | Weekly for 12 weeks | ||
| Secondary | Abnormal bowel habits improvement Responder | Weekly for 12 weeks | ||
| Secondary | Abdominal pain/discomfort relief Responder | Weekly for 12 weeks | ||
| Secondary | Changes in weekly average of SBM frequency | Weekly for 12 weeks | ||
| Secondary | Changes in weekly average of CSBM frequency | Weekly for 12 weeks | ||
| Secondary | Changes in weekly average of stool form scores | Weekly for 12 weeks | ||
| Secondary | Changes in weekly average of abdominal pain/discomfort severity | Weekly for 12 weeks | ||
| Secondary | Changes in weekly average of straining severity | Weekly for 12 weeks | ||
| Secondary | Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales) | Weekly for 12 weeks | ||
| Secondary | Safety assessed by the incidence of adverse events, vital signs, clinical laboratory tests and 12-lead ECGs | for 12 weeks |