Last updated: April 19, 2024
Sponsor: Asbjørn Mohr Drewes
Overall Status: Completed
Phase
2
Condition
Lactose Intolerance
Chronic Diarrhea
Stomach Discomfort
Treatment
Placebo
Opium tincture
Clinical Study ID
NCT05690321
Dropizol_patients
2020-000396-20
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 expectedto complete the study.
- The investigator will ensure that fertile female participants have a negativepregnancy test before each treatment visit and use contraception during theentity of the study.
- Specific underlying pathophysiology has been identified, but targeted treatment (e.g. antibiotics or bile acid sequestrants) and treatment with loperamide hasfailed. OR
- No specific underlying pathophysiology has been identified and treatment withloperamide has failed.
- At least 6 months post-surgery in the gastrointestinal tract
- No sign of cancer at standard clinical follow-up
- Chronic diarrhea defined as at least 3 daily bowel movements for the last week
Exclusion
Exclusion Criteria:
- • Known allergy towards pharmaceutical compounds similar to Dropizol.
- Participation in other studies within 14 days of first visit (1 year if opioidsinvolved).
- Expected need of medical/surgical treatment during the study
- History of psychiatric illness (e.g. mental retardation, schizophrenia, majordepression)
- History of substance abuse (e.g. alcohol, THC, benzodiazepine, central stimulantsand/or opioids)
- Family history of substance abuse
- Known major stenosis of the intestines
- Known 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 study
- Severe COPD or acute severe asthma (defined as FEV1 below 50 % or acute ongoingexacerbation)
- Known cor pulmonale
- Female participants that are lactating
- Medicine known to affect gastrointestinal motility must not be initiated duringthe entity of the study
- Treatment with opium tincture during the last month
Study Design
Total Participants: 11
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 17, 2022
Estimated Completion Date:
December 21, 2023
Study Description
Connect with a study center
Aalborg University Hospital
Aalborg, 9000
DenmarkSite Not Available
Aarhus University hospital
Aarhus,
DenmarkSite Not Available

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