Opium Tincture Against Chronic Diarrhea - Patients
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active treatment Administration of opium tincture (Dropizol) |
Drug: Opium tincture
Self-administration of opium tincture (10 mg/ml) as 3x5 drops on day 1-3, 3x10 drops on days 4-6, and 1x10 drops on day 7 in each study period
Other Names:
|
| Placebo Comparator: Placebo treatment Administration of placebo (identical to opium tincture in taste and appearance) |
Drug: Placebo
Self-administration of placebo (10 mg/ml) as 3x5 drops on day 1-3, 3x10 drops on days 4-6, and 1x10 drops on day 7 in each study period
|
Outcome Measures
Primary Outcome Measures
- Bowel movement frequency [From day 1 to 7]
Difference in number of spontaneous bowel movements per day between arms
Secondary Outcome Measures
- Gastrointestinal transit [Measurement started on day 4 of each study period until expulsion of the capsule]]
Difference in hours from ingestion of a wireless motility capsule to expulsion of the capsule during active and placebo treatment
- Stool consistency [From day 1 to 7 in each study period]
Rated on the Bristol Stool Form Scale (ranging from type 1 - type 7)
- Pupil diameter [Day 1, 4 and 7 in each study period]
Measured in mm
- General cognition [Day 1, 4 and 7 in each study period]
Evaluated using the Mini-Mental State Examination
- Reaction time [Day 1, 4 and 7 in each study period]
Measured in milliseconds (ms) from a sound was provided and until the participant pressed a button
- Short-term memory [Day 1, 4 and 7 in each study period]
Measured as number of digits correctly remembered after visual presentation
- Gastrointestinal symptoms [Day 1, 4 and 7 in each study period]
Measured on the Gastrointestinal Symptom Rating Score (GSRS) questionnaire
- Constipation symptoms [Day 1, 4 and 7 in each study period]
Measured on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire
Eligibility Criteria
Criteria
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
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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.
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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.
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Specific underlying pathophysiology has been identified, but targeted treatment (e.g. antibiotics or bile acid sequestrants) and treatment with loperamide has failed.
OR
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No specific underlying pathophysiology has been identified and treatment with loperamide has failed.
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At least 6 months post-surgery in the gastrointestinal tract
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No sign of cancer at standard clinical follow-up
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Chronic diarrhea defined as at least 3 daily bowel movements for the last week
Exclusion Criteria:
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• Known allergy towards pharmaceutical compounds similar to Dropizol.
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Participation in other studies within 14 days of first visit (1 year if opioids involved).
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Expected need of medical/surgical treatment during the study
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History of psychiatric illness (e.g. mental retardation, schizophrenia, major depression)
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History of substance abuse (e.g. alcohol, THC, benzodiazepine, central stimulants and/or opioids)
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Family history of substance abuse
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Known major stenosis of the intestines
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Known severe decreased renal function (defined as eGFR below 30)
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Known severe decreased hepatic function (defined as Child-Pugh class B or higher)
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Treatment with MAO- inhibitors during the entity of the study
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Severe COPD or acute severe asthma (defined as FEV1 below 50 % or acute ongoing exacerbation)
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Known cor pulmonale
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Female participants that are lactating
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Medicine known to affect gastrointestinal motility must not be initiated during the entity of the study
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Treatment with opium tincture during the last month
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aalborg University Hospital | Aalborg | Denmark | 9000 | |
| 2 | Aarhus University hospital | Aarhus | Denmark |
Sponsors and Collaborators
- Asbjørn Mohr Drewes
- Aarhus University Hospital
Investigators
- Principal Investigator: Asbjørn Mohr Drewes, Aalborg University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Dropizol_patients
- 2020-000396-20