Randomized controlled trial to determine the efficacy and safety of ramosetron hydrochloride in male patients with diarrheal-predominant IBS symptom
Not Applicable
- Conditions
- Irritable bowel syndrome
- Registration Number
- JPRN-UMIN000005237
- Lead Sponsor
- Department of Hepatology and Pancreatology, Kyushu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who have bowel move disturbance by organic lesion such as IBD(UC and crohn disease etc.) and cancer. 2) Patients suspected of obstruction in stomach and intestines, and with a history of total gastric resection or bowel resection but not appendicectomy 3) Patients with serious complications (liver, kidney, heart, lung, circulatory, or metabolic disorder) 4) Patients with a history of drug allergy 5) Patients who are taking psychotropic drug 6) Others, including patients who are unfit for the study as determined by the attending doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IBS-QOL-J
- Secondary Outcome Measures
Name Time Method 1.Subjective symptom (abdominal pain, abdominal fullness) 2.Defecation (bowel frequency, stool form) 3. Blood cytokine level 4.Serum concentration of serotonin 5.Patient's impression