Opium tincture against chronic diarrhea

Phase 1

• Conditions: Chronic diarrhea; MedDRA version: 20.1Level: LLTClassification code 10066556Term: Chronic diarrheaSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-000396-20-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: 2020-08-25
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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.
OR
•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

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, 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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Main objective of the trial is to describe the efficacy and safety of opium tincture (Dropizol®, Pharmanovia A/S, Denmark) against chronic diarrhea.<br> ;Secondary Objective: Not applicable ;Primary end point(s): - To evaluate changeaverage number of bowel movements per day assessed by questionnaires<br><br>;Timepoint(s) of evaluation of this end point: - at baseline and at the end of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints:<br>1. To assess regional gastrointestinal transit times and contractions with opium tincture. <br>2. To assess mental function with opium tincture.<br>3. Measure change in continuous reaction time <br>4. To evaluate subjective symptoms of diarrhea <br>;Timepoint(s) of evaluation of this end point: Healthy volunteers <br>1. at baseline and during treatment <br>2. at baseline and at the end of treatment <br>3. at baseline and at the end of treatment <br>4. at baseline, during treatment and at the end of treatment <br>