Opium tincture against chronic diarrhea - Patients: An investigator initiated, randomized placebo-controlled, clinical trial

Mech-Sense, Aalborg University Hospital0 个研究点目标入组 40 人开始时间: 2020年8月25日最近更新: 2022年1月10日

适应症

试验速览

暂无简介。

•General inclusion criteria
•Signed informed consent before any study specific procedures
•Able to read and understand Danish
•Male or female with an age of 20 years or more
•The researcher believes that the participant understands what the study entails, are capable of following instructions, can attend when needed, and are expected to complete the study.
•The investigator will ensure that fertile female participants have a negative pregnancy test before each treatment visit and use contraception during the entity of the study.
•Specific underlying pathophysiology has been identified, but targeted treatment (e.g. antibiotics or bile acid sequestrants) and treatment with loperamide has failed.
•No specific underlying pathophysiology has been identified and treatment with loperamide has failed.
•At least 6 months post-surgery
•No sign of cancer at standard clinical follow-up
•Chronic diarrhea defined as at least 3 daily bowel movements for the last week
•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 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Known allergy towards pharmaceutical compounds similar to Dropizol.
•Participation in other studies within 14 days of first visit (1 year if opioids involved).
•Expected need of medical/surgical treatment during the study
•History of psychiatric illness (e.g. mental retardation, schizophrenia, major depression)
•History of substance abuse (e.g. alcohol, THC, benzodiazepine, central stimulants and/or opioids)
•Family history of substance abuse
•Known major stenosis of the intestines
•Metal implants or pacemaker
•Severe decreased renal function (defined as eGFR below 30)
•Severe decreased hepatic function (defined as Child-Pugh class B or higher)
•Treatment with MAO- inhibitors during the entity of the study
•Severe COPD or acute severe asthma (defined as FEV1 below 50 % or acute ongoing exacerbation)
•Cor pulmonale
•Female participants that are lactating
•Medicine known to affect gastrointestinal motility must not be initiated during the entity of the study
•Treatment with opium tincture during the last month

发起方

Mech-Sense, Aalborg University Hospital