Last updated: January 27, 2023
Sponsor: Asbjørn Mohr Drewes
Overall Status: Completed
Phase
N/A
Condition
Chronic Diarrhea
Lactose Intolerance
Colic
Treatment
N/AClinical Study ID
NCT05702190
Dropizol_healthy
2020-004875-41
Ages > 20 All Genders Accepts Healthy Volunteers
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, arecapable of following instructions, can attend when needed, and are expected tocomplete the study.
- The investigator will ensure that fertile female participants have a negativepregnancy test before each treatment visit and use contraception during the entity ofthe study.
- Opioid naïve (in this study "opioid naïve" is defined as a person who does not have ahistory of opioid use/addiction. If the opioids were used more than five years beforethe start of experiment as an analgesic to treat pain post-surgery etc., this personwill be considered opioid naïve. If the person has never used opioids to treat painbut has participated in pain studies where opioids were given more than a year beforethis experiment, this person will be considered opioid naïve)
- Healthy (assessed by a study-affiliated medical doctor)
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, affectivedisorders (depression), personality disorders or treatment with psychoactivemedications)
- History of substance abuse (e.g. alcohol, nicotine, tetrahydrocannabinol (THC),benzodiazepine, central stimulants and/or opioids)
- Family history of substance abuse
- Known increased intracranial pressure
- Known major stenosis of the intestines
- Planned MRI within the next 3 months
- Metal implants or pacemaker
- Known severe decreased renal function (defined as estimated glomerular filtration rate (eGFR) below 45)
- Known severe decreased hepatic function (defined as Child-Pugh class B or higher)
- Treatment with Monoamine oxidase (MAO) inhibitors during the entity of the study
- Known severe chronic obstructive pulmonary disease (COPD) or acute severe asthma (defined as forced expiratory volume in 1 second (FEV1) below 50 % or acute ongoingexacerbation)
- Known cor pulmonale
- Female participants that are lactating
- Medicine known to affect gastrointestinal motility must not be initiated during theentity of the study
- Use of any analgesic medication within 48 hours before start as well as for theduration 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 theduration of the study.
Study Design
Total Participants: 20
Study Start date:
March 09, 2021
Estimated Completion Date:
June 01, 2022
Study Description
Connect with a study center
Aalborg University Hospital
Aalborg, 9000
DenmarkSite Not Available

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