CTIS2022-501780-41-00招募中1 期
Multicenter randomized controlled clinical trial comparing ebastine and mebeverine as treatment of irritable bowel syndrome
Z Leuven0 个研究点目标入组 200 人开始时间: 2022年12月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
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（—）
- 性别
- All
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures, Patients fulfilling the Rome IV criteria for non-constipated IBS, No organic cause that can explain the presenting symptoms (exclusion of coeliac disease (blood), lactose intolerance (breath test), inflammatory bowel disease and giardiasis (stool), Patients with lactose intolerance can be included if no improvement on lactose free diet during 6 weeks, Age 18-65
排除标准
- •History of coeliac disease, food allergy, giardiasis, inflammatory bowel disease, infectious gastroenteritis, motility disorder, serious liver kidney cardiac or pulmonary disease, known cardiac rhythm disorders, insulinedependent diabetes, psychiatric diseases, Pregnancy, breast feeding, Medication: the use of antidepressants or antipsychotics, anti-allergic medication or drugs affecting gastrointestinal motility / visceral sensitivity (anti-cholinergics, antispasmodics, 5-HT3 antagonists, 5-HT4 agonists, loperamide, codeine, laxatives, analgesics: only paracetamol is allowed as analgetic, other analgesics are forbidden.), CYP3A4-inducing and inhibiting drugs. Potent inhibitors of CYP3A4 include clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal and grapefruit. Inducers of CYP3A4 include phenobarbital, phenytoin, rifampicin, St. John’s Wort and glucocorticoids., Symptoms started following abdominal surgery, IBS constipation dominant (IBS-C), Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC of the respective medicinal products and which are listed below: For ebastine: Ingredients: microkristallijne cellulose natriumzetmeelglycolaat (type A) watervrij ypromell silicium magnesiumstearaat Filmomhulling: ypromellose titaandioxide (E171) macrogol 400 For duspatalin: Ingredients: Magnesiumstearaat, polyacrylaat dispersie 30%, talk, hypromellose, copolymeer van methacrylzuur en ethylacrylaat (1:1) dispersie 30%, glyceroltriacetaat Omhulling van de capsule: Gelatine, titaandioxide (E171), drukinkt: schellak (E904), propyleenglycol, sterke ammoniaoplossing, kaliumhydroxide, zwart ijzeroxide (E172).
研究者
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