Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Pred… (NCT02316899) | Clinical Trial Compass
CompletedPhase 3
Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
Japan500 participantsStarted 2014-10-21
Plain-language 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).
Who can participate
Age range20 Years – 79 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 depres…
What they're measuring
1
Responder rate of Global assessment of relief of IBS symptoms during 12 weeks.