A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bow… (NCT01714843) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
Japan559 participantsStarted 2012-08-10
Plain-language summary
This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome.
Who can participate
Age range20 Years – 64 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:
* 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
What they're measuring
1
Global assessment of relief of IBS symptoms Responder