NCT05690321
Completed
Phase 2
Opium Tincture Against Chronic Diarrhea - Patients An Investigator Initiated, Randomized Placebo-controlled, Double-blinded, Clinical Trial
Asbjørn Mohr Drewes2 sites in 1 country11 target enrollmentStarted: November 17, 2022Last updated:
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Asbjørn Mohr Drewes
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- Bowel movement frequency
Overview
Brief 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
Detailed Description
Opium tincture is used a symptomatic drug against chronic diarrhea even though no clinical studies have investigated the effect on gastrointestinal function. With this randomized, double-blind, placebo-controlled cross-over trial in 16 patients with chronic diarrhea, we wish to provide evidence-based insights into the effects of opium tincture on gastrointestinal function. Additionally, effects on the central nervous system will be investigated a tertiary aim.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •No specific underlying pathophysiology has been identified and treatment with loperamide 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 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
- •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
Arms & Interventions
Active treatment
Active Comparator
Administration of opium tincture (Dropizol)
Intervention: Opium tincture (Drug)
Placebo treatment
Placebo Comparator
Administration of placebo (identical to opium tincture in taste and appearance)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Bowel movement frequency
Time Frame: From day 1 to 7
Difference in number of spontaneous bowel movements per day between arms
Secondary Outcomes
- General cognition(Day 1, 4 and 7 in each study period)
- Gastrointestinal transit(Measurement started on day 4 of each study period until expulsion of the capsule])
- Stool consistency(From day 1 to 7 in each study period)
- Pupil diameter(Day 1, 4 and 7 in each study period)
- Reaction time(Day 1, 4 and 7 in each study period)
- Short-term memory(Day 1, 4 and 7 in each study period)
- Gastrointestinal symptoms(Day 1, 4 and 7 in each study period)
- Constipation symptoms(Day 1, 4 and 7 in each study period)
Investigators
Asbjørn Mohr Drewes
Professor
Aalborg University Hospital
Study Sites (2)
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