Opium Tincture Against Chronic Diarrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-17

Study Completion Date

2023-12-21

Brief Summary

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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

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Detailed Description

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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

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Chronic Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active treatment

Administration of opium tincture (Dropizol)

Group Type ACTIVE_COMPARATOR

Opium tincture

Intervention Type DRUG

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

Placebo treatment

Administration of placebo (identical to opium tincture in taste and appearance)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Dropizol

Eligibility Criteria

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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.

OR

* 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
* 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No