Histamine 1 receptor antagonist ebastine as novel treatment in IBS

KULeuven0 个研究点目标入组 200 人开始时间: 2013年9月24日最近更新: 2024年6月10日

适应症

试验速览

暂无简介。

•1. Patients must meet the Rome III criteria for Irritable Bowel Syndrome:
•? 3 days per month, continuous or not, in the last 3 months have abdominal discomfort or pain, with at least two of the following three characteristics:
•- Reducing after defecation, and / or
•- associated with a change in frequency of stool, and / or
•- associated with a change of consistency / shape of the stool
•2. No identifiable organic explanation for the symptoms (including the execution of a test for lactose intolerance, celiac disease and giardia test)
•3. Age 18-65 years
•4. Signed informed consent
•5. Symptoms during the two weeks of screening
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 200
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. IBS constipation dominant
•2. Patient with history of:
•Celiac disease, Known milk allergy, giardiasis, inflammatory bowel disease, active intestinal infection, chronic intestinal ischemia, chronic subobstruction, pseudo-obstruction, dumping syndrome, pancreatic insufficiency, hepatic impairment, renal function impairment, cardiovascular disease, extensive gastrectomy and/or bowel resection, active malignant disease, thyroiddysfunction, insulin dependent diabetes mellitus, psychiatric disorder, any clinical condition in which the researcher does not allow to terminate the study safely
•3. Pregnancy, lactation
•4. Medication: Use of anti-allergica, antidepressants, and antipsychotics
•5. Patient uses drugs that reduce gastrointestinal motility and / or affect the visceral perception (anticholinergics, antispasmodics, 5-HT4 agonists, cholinomimetics, loperamide, laudanum, codeine, stimulant laxatives, macrogol, paraffin oil, analgesics).
•6. Complaints arise after abdominal surgery

发起方

KULeuven