CompletedNCT05690321Updated Apr 22, 2024

Opium Tincture Against Chronic Diarrhea - Patients

A Phase 2 interventional study of Opium tincture and Placebo in Chronic Diarrhea, sponsored by Asbjørn Mohr Drewes. Completed at 2 sites in Denmark. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-04-22.

Sponsored by Asbjørn Mohr Drewes · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 11
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study 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

Read the 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.

Conditions studied

Chronic Diarrhea

Browse trials for

Diarrhea 852

Keywords

Diarrhea
Gastrointestinal transit

In context

Diarrhea

852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.

This study's enrollment of 11 is below the median of 136 across 713 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

Asbjørn Mohr Drewes is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: 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

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
  - Severe COPD or acute severe asthma (defined as FEV1 below 50 % or acute ongoing exacerbation)
  - Known 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

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 11 participants (actual)

Study arms

Active comparator
Active treatment
Administration of opium tincture (Dropizol)
Drug: Opium tincture
Placebo comparator
Placebo treatment
Administration of placebo (identical to opium tincture in taste and appearance)
Drug: Placebo

Interventions

DrugOpium 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
Also known as: Dropizol
DrugPlacebo
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

What researchers measure

Primary outcomes

Bowel movement frequency
Difference in number of spontaneous bowel movements per day between arms
Time frame: From day 1 to 7

Secondary outcomes

Gastrointestinal transit
Difference in hours from ingestion of a wireless motility capsule to expulsion of the capsule during active and placebo treatment
Time frame: Measurement started on day 4 of each study period until expulsion of the capsule]
Stool consistency
Rated on the Bristol Stool Form Scale (ranging from type 1 - type 7)
Time frame: From day 1 to 7 in each study period
Pupil diameter
Measured in mm
Time frame: Day 1, 4 and 7 in each study period
General cognition
Evaluated using the Mini-Mental State Examination
Time frame: Day 1, 4 and 7 in each study period
Reaction time
Measured in milliseconds (ms) from a sound was provided and until the participant pressed a button
Time frame: Day 1, 4 and 7 in each study period
Short-term memory
Measured as number of digits correctly remembered after visual presentation
Time frame: Day 1, 4 and 7 in each study period
Gastrointestinal symptoms
Measured on the Gastrointestinal Symptom Rating Score (GSRS) questionnaire
Time frame: Day 1, 4 and 7 in each study period
Constipation symptoms
Measured on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire
Time frame: Day 1, 4 and 7 in each study period

Study locations

2 sites

Aalborg University Hospital
Aalborg, 9000, Denmark
Aarhus University hospital
Aarhus, Denmark

References and documents

Individual participant data

Plan to share: Yes — Data can by provided upon request

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05690321
Lead sponsor: Asbjørn Mohr Drewes
Collaborators: Aarhus University Hospital
Responsible party: Asbjørn Mohr Drewes (Professor, Aalborg University Hospital) — Sponsor-investigator
First posted: Jan 19, 2023
Start date: Nov 17, 2022
Primary completion: Dec 21, 2023
Completion: Dec 21, 2023
Last update: Apr 22, 2024

Study contacts

Asbjørn Mohr Drewes

principal investigator · Aalborg University Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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