CTIS2022-501800-92-00进行中（未招募）1 期
Menthacarin® in the treatment of functional gastrointestinal disorders - D.02.01.2.02
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 65+（—）
- 性别
- All
入选标准
- •Adult male or female subject (=18 years old), Written informed consent in accordance with the legal requirements is voluntarily provided by the patient prior to the beginning of any trial-related tasks or investigations, Patient with willingness and ability to comply with all trial procedures and to attend all scheduled visits at the investigational site, Patient suffering from a functional gastrointestinal disorder: Patient suffers from at least one of the following functional abdominal symptoms at least 1 day/week for = 3 months on: - abdominal pain/cramping - bloating feeling, The presence of at least one of the functional abdominal symptoms - abdominal pain/cramping - bloating feeling - postprandial fullness with an intensity of = 4 points on a 0-10 points numeric rating scale (NRS) on at least one day within the last week prior to visit 1 (assessed retrospectively at visit 1), At visit 2 only: At least one of the functional abdominal symptoms - abdominal pain/cramping - bloating feeling - postprandial fullness assessed already at visit 1 with an intensity of = 4 points on a 0-10 NRS, was present on at least one day within the last week prior to visit 2 with an intensity of = 4 points on a 0-10 NRS (documented by daily diary assessment).
排除标准
- •Patient in whom abdominal symptoms are caused by an organic cause., Patient is immunocompromised (e.g. AIDS, lymphoma, long-term corticosteroid treatment)., Patient with a malignant disease or undergoing chemotherapy or radiation therapy, Patient with known or suspected history of alcohol or drug abuse according to the opinion of the investigator, Female patient who is pregnant, breast-feeding or planning pregnancy during the course of this clinical trial, Female patient of child-bearing potential not using or not willing to use consistently and correctly throughout the duration of this clinical trial one of the following contraceptive methods: established use of implants, injectables, or combined hormonal oral, intravaginal or transdermal contraceptives, placement of an intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), sexual abstinence and vasectomised partner, Patient exhibiting or indicating thoughts of suicide currently or in the past, Planned surgical intervention during the clinical trial, Previous inclusion in the present clinical trial, Patient participating in another clinical trial at the same time, or has taken part in a clinical trial within the last 30 days before inclusion in the present clinical trial, Patient unable to read and / or write, Patient with constipation and/or changes in bowel movements alternating between normal bowel movements and constipation, Patient who are members of the staff of the trial site, staff of the sponsor or involved Clinical Research Organizations (CROs), the investigator him- / herself or close relatives of the investigator, Evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel transit, Patient is currently experiencing bloody diarrhoea, Known hypersensitivity to peppermint, menthol, caraway, to umbelliferous plants or other ingredients of the investigational medicinal product, Concomitant use of any other treatments for functional gastrointestinal disorders, including herbal preparations (other than the investigational medicinal product), Patient is suffering from reduced production of gastric acid (achlorhydria), Liver diseases, Gallstones, inflammation of the bile duct (cholangitis) or other diseases of the gall
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