NL-OMON55611已完成2 期
Perifere histamine 1 receptor blokkade in PDS - Peripheral histamine 1 receptor blockade in IBS
Z Leuven0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Patients meet the ROME III criteria for IBS and is NOT diagnosed with the
- •constipation dominant subform of IBS (IBS-C), 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
排除标准
- •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, breastfeeding, 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,
- •anti-inflammatory agents) OR mediaction knwon to prolong QTc-interval
- •(antifungals (ketoconazol) and macrolides (erytromycien, claritromycine))., 6.
- •Complaints arise after abdominal surgery
研究者
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