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NCT05690321
Opium Tincture Against Chronic Diarrhea - Patients
Conditions: Chronic Diarrhea
Sex: All
Ages: 20 Years – N/A
Phase: PHASE2
Enrollment: 16
Sponsor: Asbjørn Mohr Drewes
Location: Denmark
Summary
The purpose of this study is to investigate the mechanistic anti-propulsive effects of opium tincture on the gastrointestinal tract of a cohort of patients with chronic diarrhea
Eligibility Criteria
Inclusion Criteria:• Signed informed consent before any study specific proceduresAble to read and understand DanishMale or female with an age of 20 years or moreThe 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.ORNo specific underlying pathophysiology has been identified and treatment with loperamide has failed.At least 6 months post-surgery in the gastrointestinal tractNo sign of cancer at standard clinical follow-upChronic diarrhea defined as at least 3 daily bowel movements for the last weekExclusion Criteria:• 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 studyHistory 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 abuseKnown major stenosis of the intestinesKnown severe decreased renal function (defined as eGFR below 30)Known severe decreased hepatic function (defined as Child-Pugh class B or higher)Treatment with MAO- inhibitors during the entity of the studySevere COPD or acute severe asthma (defined as FEV1 below 50 % or acute ongoing exacerbation)Known cor pulmonaleFemale participants that are lactatingMedicine known to affect gastrointestinal motility must not be initiated during the entity of the studyTreatment with opium tincture during the last month
Source: ClinicalTrials.gov (NCT05690321). StuddyBuddy aggregates publicly available trial information.