Opium tincture against chonic diarrhea

Phase 1

• Conditions: Chronic diarrhea - The effect of opium tincture on the gastrointestinal function; MedDRA version: 20.1Level: LLTClassification code 10066556Term: Chronic diarrheaSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-004875-41-DK
• Lead Sponsor: Mech-Sense, Aalborg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-12
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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.
•Opioid naïve*
•Healthy (assessed by a study-affiliated medical doctor)

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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion 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 study
•History of psychiatric illness (e.g. mental retardation, schizophrenia, affective disorders (depression), personality disorders or treatment with psychoactive medications)
•History of substance abuse (e.g. alcohol, nicotine, THC, benzodiazepine, central stimulants and/or opioids)
•Family history of substance abuse
•Increased intracranial pressure
•Known major stenosis of the intestines
•Planned MRI within the next 3 months
•Metal implants or pacemaker
•Severe decreased renal function (defined as eGFR below 45)
•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
•Use of any analgesic medication within 48 hours before start as well as for the duration of the study (urine drug test will be performed prior to treatment start).
•Intake of alcohol within 48 hours before start of study period as well as for the duration of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified