Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

• Status: Completed
• Trial end date: 2016-03-29
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Linaclotide

Criteria

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